FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078714 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 28/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathic Medicine in Gout In Old Age Patient. 
Scientific Title of Study   Role Of Homoeopathy In Gout In Geriatrics 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Prakashbhai Rajai 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Practice of Medicine Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
Surat
GUJARAT
395001
India 
Phone  9081595927  
Fax    
Email  rajaimansi6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ayaz Dawoodbhai Ghoghari 
Designation  Assistant Professor In Practice Of Medicine  
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Practice of Medicine Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
Surat
GUJARAT
395001
India 
Phone  9016537835  
Fax    
Email  ayazghoghari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mansi Prakashbhai Rajai 
Designation  M D Scholar Part 2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine and Hospital 
Address  Department Of Practice of Medicine Division Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
Surat
GUJARAT
395001
India 
Phone  9081595927  
Fax    
Email  rajaimansi6@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College Of Homoeopathic Medicine and Hospital Surat 395001 Gujarat India  
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine And Hospital  
Address  C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Anand Mangal Society Bhatar road Surat 395001 Gujarat India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mansi Prakashbhai Rajai  CD Pachchigar College Of Homoeopathic Medicine And Hospital   Department Of Practice of Medicine Division Of MD 2nd Floor CD Pachchigar College Of Homoeopathic Medicine And Hospital Surat 395001 Gujarat India
Surat
GUJARAT 
9081595927

rajaimansi6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C D Pachchigar College Of Homoeopathic Medicine And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M109||Gout, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine   Homoeopathic Medicine Dose As Per Requirement Of Case Through Sublingual Mode Of Administration Within Time Duration Of 9 Months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age group 65 year and above along with both sex irrespective of socioeconomic condition and religion.
Cases which are diagnosed clinically according to patient history and sign and symptoms,High Serum uric acid.
Veg and nonveg diet and family history will be included.
Pre diagnosed case
Drug induced gout case.
Rome criteria for diagnosis of gout.
 
 
ExclusionCriteria 
Details  Advance pathological cases along with comorbidities will be excluded
Critical emergency and surgical case
Irreversible pathological and genetic disorder case are excluded cases with irregular follow up and patient who left the treatment in between.
Patient who does not follow diet and regimen

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Removal Of Symptoms Of Patient  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To Relief The Patient From Gout Triggering Factor And To Give Healthy Life In Old Age Patient  Within 9 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

6

BRIEF  RESUME  OF  INTENDED  WORK:

6.1

NEED  FOR  STUDY:

          Gout is once known as ‘’Disease of king and king of diseases ‘. It is most common form of inflammatory arthropathy that develop when crystal of uric acid build up in the body. (1)It causes   sudden, severe attack of pain, tenderness, redness, warmth and swelling in some joints.

        The prevalence of   gout <1% to 6.8% and an incidence of 0.58 _ 2.89 per 1,000 person-years. (2) A recent cross-sectional study conducted in a managed care population using data from 1990–1999 found a 60% increase in prevalent gout over 10-years. (3) Worldwide incidence of gout increases gradually due to poor dietary habits such as fast foods, lack of exercises, increased incidence of obesity, seafood, sugary food and drinks ,alcoholic consumption .Certain medication like aspirin, diuretic drug and some genetic disorder also affect. There are also some other risk factors, such as medical conditions like diabetes, kidney diseases and cardiovascular  diseases. (3)Gout is one of the true crystal deposition disease and inflammatory monarticular arthritis which further lead to polyarticular arthritis. It occurs in response to presence of monosodium urate crystal in joint, bone, soft tissues. Hyperuricemia - increased uric acid pool is the biological hallmark of Gout. Many times it is confused as rheumatic condition i.e rheumatoid arthritis resemblance in presentation.  Hyperuricemia may do not have gout; however the risk of gout increases dramatically with increasing serum urate level. In most cases, patients seeking allopathic treatment for gout take frequent painkiller to get rid of pain. The painkiller will provide temporary relief but the main problem persists. Homoeopathy is a system of medicine which focuses on treating man as a whole and not just symptoms.

       Homoeopathy believes in individualization, and law of similia similibus curanter. So, medicines are selected on basis of symptom similarity in each suffering individual. Thus, homoeopathic medicines help treat disease from root cause, and treat man as a whole.   Homoeopathic medicines can be a big boon for all those who suffer from high uric acid. Homoeopathic medicines will not only treat the symptoms of gout but these medicines will work by reducing the uric acids overproduction by the body and accelerating the removal of this waste product through the kidneys by restoration of harmony in vital functions of individuals.Homeopathy helps in controlling the pain during the acute attack of gout as well as helps in preventing the recurrence of such episodes. It helps in reducing stiffness and improves the mobility of the joints. Homoeopathy medicine can be seen helpful to see changes intensity of pain and which potency is affected in which geriatric age group, physical and mental symptoms changes of patient, life and living of patient how is changed, uric acid level changes .With continued treatment from a homeopath, the patient notices reduction in the frequency of attacks and intensity of pains with gradually leading to complete relief .The disease can be removed only if cause is removed. Thus, Homeopathic medicines can be used for the long-term care for gout and improve the quality of life of old age

6.2

REVIEW  OF  LITERATURE:

 

Historical Concept-

          Egyptians were the first to recognize gout as a disease in 2640 BC. Hippocrates recognized its debilitating nature by the fifth century BC, calling it the “unwalkable disease.” Galen was also first to description of tophus as chalk like structure. Podagra, a manifestation of gout, was first used by a Dominican monk named Randolphus of Bocking in 1200 AD. In Greek, pod means “foot” while Agra translates to “seizure” or “to take.” The term also has Latin roots, with the word gutta translating to “drop.’ (4)

        Alexander of Tralles (525 – 605 A.D.), a Byzantine physician, and his contemporary, Aetius, were the first to indicate the usefulness of colchicum in the treatment of gout. (4)

         In 1683 English physician Sydenham distinguished gout from other form of arthritis and differentiated an acute and advanced [chronic] form (5) .Anton van Leeuwenhoek (1632–1723), the Dutch biologist who became the father of microscopy, discovered that the gouty tophus was made up of crystals, but the actual nature of the crystal remained unknown. In 1776 the chemical identity of uric acid was first established as a constituent of a renal calculus by the Swedish chemist Scheele, and the English chemist Woolaston demonstrated urate in a tophus from his own ear in 1797 (4)

          It was not until 1763 that the Viennese physician Baron von Storck began to use colchicum extract specifically for terminating acute gouty attacks. In the mid-1800s, Sir Alfred B. Garrod published identification of increased levels of uric acid published his identification of increased levels of uric acid in the blood of gouty patient’s investigations that characterize many of the aspects of clinical gout as clinicians know it today. In the late 1800s, it was discovered that high-dose salicylates were an efficacious remedy for acute gout (6). McCarty and hollander publish experiments which demonstrate that synovial fluid contain monosodium urate crystals which would serve as basis for diagnosis of gout (4)

 

DEFINATION –

Gout is the term used to describe the constellation of clinical features that result from deposition of microcrystals of sodium urate monohydrate or uric acid from hyperuricaemic body fluids.

 

These include acute arthritis, tenosynovitis, bursitis or cellulitis, tophaceous deposits ,renal disease and urolithasis (7)

 

EPIDEMIOLOGY: -

•       The incidence of gout varies in population from 0.2 to 3.5 per 1000, with an overall prevalence of 2-26 per 1000.

•       Gout is found to have increased prevalence in recent years.

•       It is rare in children and premenopausal females.

•       The risk of developing gout increases with age   and   with serum uric acid (SUA) levels.

•       Serum uric acid levels are higher in men, increase with age and are positively   associated with body weight. (8)

•       Prevalence rises up to 10% in men and 6% in women more than 80 years old age.

•       It occurs in men 2–6 folds more than women. (9)

ETIOLOGY  :-

Gout happens when urate, a substance in your body, builds up and forms needle-shaped crystals in your joints.  This leads to:-

       Pain, Swelling, Redness, Changes in how you move and use the affected joint. .

The other factor to develop gout  :--

High urate levels and a family history of gout .Mostly seen in men than female [postmenopausal] with increasing age. Drinking alcohol and sugar-sweetened beverages, such as soda. Having an unhealthy diet and eating foods that are rich in purines (usually from animal sources), a substance that breaks down into urate. A group of conditions that include high blood pressure, high blood sugar, abnormal cholesterol levels and obesity. Chronic kidney disease, psoriasis, cancer. Rare genetic conditions that lead to increased urate. Diuretics, Low-dose aspirin, fructose syrup and some other medications. (10)       

 

PATHOGENSIS-

     About one-third of the body uric acid pool is derived from dietary sources and two -thirds from endogenous purine metabolism.

 

        The concentration of uric acid in body fluids depends on the balance between endogenous synthesis and elimination by the kidneys (two-thirds) and Gut (one-third).

 

          Purine nucleotide synthesis and degradation are regulated by a network of enzyme pathways, but xanthine oxidase plays a pivotal role in catalysing the conversion of hypoxanthine to xanthine and Xanthine to uric acid (8)

CLINICAL FEATURES:-

      The classical presentation is with an acute monoarthritis , which affects

 the  first metatarsophalangeal joint in over 50% of cases.  Other common sites are the ankle, mid foot, and knee, small joints of hands, wrist and elbow. Large proximal joints are rarely involved. Typical features include: rapid onset, reaching maximum severity in 2–6 hours, worse in the early morning. Severe pain, often described as the ‘worst pain ever’.

       Extreme tenderness, so the patient is unable to wear a sock or to let bedding rest on the joint .Marked swelling with overlying red, shiny skin.

Self-limiting over 5–14 days, with complete resolution.

        During the attack, the joint shows signs of marked synovitis, swelling, erythema. There may be accompanying fever, malaise and even delirium, especially if a large joint such as the knee is involved.   As the attack subsides, desquamation of overlying skin are common .In old age may be atypical, with painful tophi and chronic symptoms, rather than acute attacks. In old age may be atypical, with painful tophi and chronic symptoms, Rather than acute attacks. Joints of the upper limbs are more frequently affected Some people never have a second episode and in others several years may elapse before a second attack occurs. Patients with repeated attacks may progress to chronic gout, with chronic pain, joint damage, deformity and functional impairment. Patients with uncontrolled hyperuricaemia who suffer multiple attacks of acute gout may also progress to chronic gout .Crystals may be deposited in the joints and soft tissues to produce irregular firm nodules called tophi. Tophi have a white color, differentiating them from rheumatoid nodules (8).

 

CLINICAL CLASSIFICATION

Gout can occur in four phases –

 

ASYMPTOMATIC HYPERURICEMIA:-

Majority of patients with asymptomatic hyperuricemia never develop gout. The risk of acute gout attack increases with the level of serum urate. This stage ends with the first gout attack. (1)

 

ACUTE  GOUTY ARTHRITIS :-

    The big toe (first metatarsophalangeal joint) is the classic site for gout. One-third of patients may get their first attack at another site such as the in-step of the foot, ankle, knee, or hand, joints. The attack is   acute, it starts in the night, the joint and surrounding tissues the signs are swollen, hot, red, shiny and extremely painful. There is a mild fever with chills. (11)Left untreated, the attack will start to improve in a week or two and the skin over the involved joint may desquamate as the episode subsides.

    Atypical manifestations include bursitis, cellulitis or mild pain and discomfort without swelling, lasting a day or two. The erythema over affected joint during an attack is characteristic of gouty synovitis .Acute gout in one joint may provoke migratory attacks affecting other joints over subsequent days. Acute gout can precipitate by dietary excess, trauma, surgery and many other medical illness Polyarticular gout attacks are more common in women, especially with diuretic use.

        First attacks are seldom associated with residual disability, but recurrent attacks are followed by progressive cartilage and bone erosion, deposition of tophi, secondary osteoarthritis and disability associated with permanent restriction of joint function. (7)

 

 

 

 INTERCRITICAL GOUT :-

After an acute attack, some people never have a second episode, in others next episode occurs after years. In most a second attack may occur within one year and the frequency of attacks gradually increases with time. After resolution of the acute attack, the patient is in the inter-critical stage. (11)  Although the disease seems to be inactive, hyperuricemia persists, and subclinical inflammation may be present in the joints (1). Monosodium urate crystal deposit continues.

 

CHRONIC TOPHACEOUS GOUT:-.

       Although patients may present with tophi as their initial symptom, chronic tophaceous gout usually develops ten or more years after an acute attack. However, microtophi are documented early in the disease in patients with hyperuricemia. (1) Tophi appear as firm, nodular or fusiform swellings. In inflamed tophi, the overlying skin may be erythematous. In ulcerated tophi, white chalky material, the urate crystals, may exude. (11)Tophi may be intra articular, per articular, or extra-articular, the most common sites being the digits of hands and feet, knees, and the olecranon bursa. They lead to destructive deforming arthritis with extensive bone destruction. (1)

       Tophi may develop rapidly in feet or hands of post-menopausal women with heart failure and renal insufficiency who develop acute or sub-acute gouty arthritis following prolonged diuretic administration. Crystal deposits appear in cartilage, synovial membranes, tendons and soft tissues. The classic location of a tophus is the helix and antihelix of the ear. (12)

 

After gouty arthritis, renal disease is the most frequent complication of hyperuricaemia. Urate nephropathy is attributed to the disposition of monosodium urate crystals in the renal interstitial tissue. Other manifestations include uric acid calculi (11).

 

PROGNOSIS :-

The prognosis of gout depends on the comorbidity of each individual.

Mortality is higher in individual with cardiovascular comorbidity.

When gout receives proper treatment, most patients will live a normal life with mild sequelae.

Patients whose symptoms appear earlier in life will usually have a more severe disease at presentation.

For those who do not modify their lifestyle, recurrent flare-ups are common. (1)

 

DIFFERINCIAL DIAGNOSIS:-

1. Rheumatic arthritis

2. Osteoarthritis

3. Septic arthritis

4. Crystalline-associated arthropathies Calcium pyro-phosphatase deposition   disease (CPPD)

 5. Psoriatic arthritis (1)

 

INVESTIGATIONS:-

1. Synovial fluid analysis

2. Serum uric acid level

3. Urine analysis

4. Renal function test

5. X-ray of affected part

6 CRP

7 ESR

8 CT scan (1)

 

COMPLICATION:-

Tophi, joint deformity, osteoarthritis, bone loss.  Urate nephropathy and nephrolithiasis.Gout might also cause ocular complications, such as conjunctivitis, uveitis from the urate crystal precipitation. (1)

 

TREATMENT:-

Acute gout

NSAIDs, Colchicine Local or systemic corticosteroids

Long term treatment = Uricosuric drug – allopurinol, febuxostat, probencid.

Treat associated problems, e.g. obesity, hyperlipidemia, hypertension (13)

 

MANAGEMENT:-

 Dietary changes – Avoiding Purine rich food such as asparagus, spinach , red meat, organ meat, sea food, food rich in fructose –sugary drinks, alcohol- especially beer and hard liquor.

Stress relief – Yoga and Meditation

Physical activity – Exercise, Controlled weight reduction in obese patients. Avoiding use of thiazides or loop diuretics, niacin and other medications. (12)

 

HOMOEOPATHY VIEW –

          Homoeopathy is based upon the easily comprehensible principle, law of nature, individualization and restores the sick to health gently. In gout, homoeopathy can give cure in acute as well as chronic cases. Certain homoeopathic medicines work directly on the "uric acid diathesis," but the constitutional method of taking a holistic approach to case taking, analyzing symptoms, and then choosing a similimum for a chronic case will lead to a cure. The totality of symptoms in the mental and physical plane and peculiar characteristic symptoms help in finding the similimum. Homoeopathy has a holistic approach to patients, homoeopathic medicines help and improve the general health of person, because it treats the person as whole and not only the disease.

 

         One of the three principles of homeopathy is the law of similars: ‘similia similibus   curantur’, which means ‘like cures like.’ Put simply, a disease is cured with a substance that causes similar symptoms/disease in a healthy human being.Individualization in Homoeopathy includes its unique holistic consultation process, means two persons having the same complaints will vary in their symptoms,presentation, modalities, physical makeup and mental expressions which will be known by a proper case taking. Homoeopathy is the science dealing with the deranged vital force and functional changes in the individual patient, irrespective of the name of the disease.

     

“Gout and Its cure by J. Compton Burnett”

“In a given case of gout the symptoms are not those of the individual himself, but of its material presence in the individual : the pain, the swelling, the redness, the tenderness, the fever, the restlessness- these are produced by the gouty material, which we see from the fact that they disappear as soon as this material is washed out ; so that what we require are remedies that are homeopathic to the state of the patient which preceded the gouty deposit into the tissue, inclusive of these deposits.In fact ,the pathology of gout must be considered, in prescribing adequately ,Homeopathically.” (14)

 

In aphorism 259, Dr Hahnemann advises for consider minuteness of dose necessary and proper in homoeopathic treatment everything must be removed from diet and regimen which can have any medicinal action , in order that the small dose may not be overwhelmed and extinguished or distributed by any foreign medical irritant. (15)

Hahnemann in aphorism 153 states that more importance is given to the characteristics which is defined as the more striking, singular, uncommon, peculiar, signs and symptoms which help in finding out a similimum cure and ‘supply where necessary. (15)

In 261 Aphorism, Dr Hahnemann gives an idea about the most appropriate regimen, removal of obstacles for cure and ‘supply where necessary. (16)

 

Some of homoeopathic remedy which are much important for treatment of gout from source book like. Homoeopathic Therapeutics by ,

Lilienthal, Phatak, and Robert [The Rheumatic Remedies], Boericke’s new manual of homoeopathic materia medica. Are as under –

 

1] ANTIMONIUM CRUDUM - Weakness and shaking of hands in writing, followed by offensive flatus. Twitching in muscles. Jerks in arms. Pain in the joints of fingers. Pain in feet. (17)  Worse in evening, better open air. (18)

 

2] ABROTANUM Pain in shoulders, arms, wrists, and ankles. Pricking and coldness in fingers and feet. Contraction of limbs worse cold air (17) , better motion. (18)

 

3] BELLADONNA – Shifting rheumatic pain; jerking limbs, agg touch (18).

 

4] BENZOICUM ACIDUM – Nodes and gouty concretions on the joints of upper and lower limb; cracking in the joints on motion (urates of soda); urine very deep red, strong-smelling, and of high specific gravity (19) , worse open air. (18)

 

5] BRYOINA ALBA – joints red, swollen hot. Pins and needles in soles, preventing walking. Constant motion of left arm and leg, with sighing. Swelling of elbow. Knees totter and bend under him when walking. (17) worse touch better pressure (18)

 

6] COLCHICUM AUTUMNALE- where the gout attacks many joints, with burning and tearing pains, aggravated by the touch, and at night muscular pains, swelling, and coldness of legs and feet, with the pain, weariness, heaviness, and inability to move ; feeling of muscular weakness. (19)

 

7] GUAIACUM -Gouty inflammation and abscess of the knee ; followed by contraction of limbs ; immovable stiffness of the contracted limbs ; can bear no heat, with pain in joints (19),worse motion (18)

 

8] LEDUM - (maltreated by large doses of Colchicum); lancinating, tearing pains; worse by motion and at midnight, when joints feel so hot that he throws off’ all covering; ball of great toe swollen and painful, gouty nodosities in joints; fine tearing pain in toes. (19)

 

9] LYCOPODUM CLAVATUM – Tophi , ameliorated by heat ; muscular contractions ; drawing, tearing in the limbs at night and on alternate days ; worse at rest ; muscles and joints rigid, painful, with numbness ;  better in warmth (19); alternation of heat and cold in gout . (20)

 

10] RHODODENDRON CHRYSANTHUM - Arthritic node; paralytic weakness of the limbs, aggravated in rough weather, and rest; sensation in lower legs and feet as if asleep. (19)

 

11] SULPHUR –For gout; urine charged with uric acid; stiffness in the knee or ankle-joints; better by dry warm weather. (19)

 

12] URTICA URENS- Continuous Pain in deltoid [right]; agg rotating arm inwards; could not put on the coat; acute gout (17) worse from touch. (18)

 

Many more of medicine are present for gout.

 

6.3

 

 

 

 

OBJECTIVE  OF  THE  STUDY:

 

-       To study the clinical presentation   of gout in geriatrics age group.

-        To determine the role of individualized homoeopathic medicine in treatment of gout in   geriatric’s age group.

 

 

7

Material  and  Methods:

7.1

SOURCES  OF  DATA:

 

 O.P.D & I.P.D OF C.D.Pachchigar homoeopathic medical college and hospital.

Peripheral centre O.P.D allotted by C.D.Pachchigar homoeopathic medical college and hospital

 

7.2

MATERIALS:

1.    College OPD standard case taking format.

2.    Homoeopathic software Synthesis by Dr. Frederik Schroyens, MD. 

3.    Consent form of patient.

4.    Various books of allied science, MateriaMedica and Organon, Repertory, online materials.

5.     Rome Diagnostic  Criteria for gout

 

7.3

METHOD  OF  COLLECTION  OF  DATA:

1.    Study design – Experimental study.

2.    Study type – Prospective study.

3.    Study population – cases having complain of Gout who treated with homoeopathic medicine at C.D. Pachchigar College of homoeopathic medicine and hospital.

4.    Sample size – 30 cases.

5.    Sampling techniques-simple randomization.

6.    Selection criteria.

Case will be taken from IPD & OPD of C.D.Pachchigar homoeopathic medical college and hospital.

 

Periphery OPD of C.D.Pachchigar homoeopathic medical college and hospital.

 

According to the Rome criteria, to be diagnosed with gout, patients must meet 2 of the following 4 criteria: -

1.    History of attack of painful ,swollen joints with abrupt onset and initial remission with in one to two weeks

2.    Serum uric acid level >7mg/dl in men / women >6 mg/dl

3.    The presence of tophi

4.    Monosodium urate crystal in synovial fluid or tissues (21)

 

 Inclusion criteria-

1.    Age group 65 year and above along with both sex irrespective of socioeconomic condition and religion.

2.    Cases which are diagnosed clinically according to patient history and sign and symptoms, high serum uric acid.

3.    Veg and non – veg diet and family history will be included.

4.    Pre diagnosed case

5.    Drug induced gout case.

6.    Rome criteria for diagnosis of gout.

 

Exclusion criteria.

(1)  Advance pathological cases along with comorbidities will be  excluded

(2)  Critical emergency and surgical case

(3)  Irreversible pathological and genetic disorder case are excluded cases with irregular follow up and those patient who left the treatment in between.

(4)  Patient who doesnot follow diet and  regimen

 

-       Follow up cases will be done at every 7,15,21,30 days as per requirement of case.

 

-       Patient who  come under  withdrawal criteria as follows :-

Any Anticipated circumstances Principal Investigator may terminate the research on Patient, regardless of Patients consent.

The patient is not benefitting from the treatment than patient can withdraw.

Any patient who is found to be uncooperative during the study.

Any patient who wishes to withdraw his/her consent for participation in the study.

If any patient met with the emergency state like accident

-       If the patient did not report for the 2 regular follow-ups than patient will be dropped out from the study

 

-       Patient with Informed concerned:-

All the patients will be informed about the research study and their role in the study through patient information sheet.

 

All the enrolled patients will be giving voluntary consent as per the format.

 

 

 

-       Intervention-

 

Medicines will be dispensed from the dispensed from periphery OPD of    C.D.Pachchigar homoeopathic medical college and hospital.

 

 IPD & OPD of C.D.Pachchigar homoeopathic medical college and   hospital.

-       All the data will be recorded in standardized case record with the following steps –

 

•       Recording and interpretation.

•       Analysis of the case.

•       Synthesizing the case.

•       Erecting totality.

•       Repertorization.

•       The higher matched and graded medications in the repertorized chart will be analyzed and then validated from Homoeopathic Materia Medica to arrive at the prescription.

-       Selection of medicine in each case will be based on the data such as etiological factors, mental, physical generals, concomitants, characteristic particulars, repertorial approach and clinical indications ; on the basis of totality of symptoms

-       The remedy will be selected on the basis of totality of symptoms and either from reportorial or non-reportorial approach

 

-       In each case suitable potency will be selected according to demand of the case based on Homoeopathic principles, with consideration of the potency selection criteria of  susceptibility of patient

 

-       Dose and Repetition of remedy will be done according to Homoeopathic principles laid down in Organon of medicine

 

-       All the medicines will be administrated through oral , sublingual route

 

-       All the records will be maintained as per standard procedure of institution

 

-       Response will be analysed in to 3 criteria :-

 

SIGNIFICANT IMPROVEMENT = General improvement at all levels with the feeling of wellbeing both mentally and physically with disappearance of the presenting symptoms

 

MODERATE IMPROVEMENT = patient relieved from presenting complains in frequency and intensity and duration.

 

Mild Improvement – Patients who will have symptomatic amelioration.

 

NO IMPROVEMENT = when there is neither increase nor decrease in the intensity of symptoms.

 

-       Analysis and evaluation will be done based on homoeopathic principles for totality formation

 

-       Conclusion:-

        Patient’s record will be maintained to draw the conclusion.

        Conclusion will be drawn in view of the objectives laid down in the study

-       Ethical issues:-

    Informed consent will be obtained from every patient.

    All the forms, reports and the records will be kept confidential

 

 

7.4

DOES  THE  STUDY  REQUIRING ANY  INVESTIGATION  TO  BE CONDUCTED  ON  PATIENTS  OR OTHER  HUMANS  OR  ANIMALS?

 

 

As per requirement of the case

7.5

 

HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE?

 

 

YES

 

 

 

 

 

 


8

BIBLIOGRAPHY :

 

 

1.

Fenando A, Rednam M, Gujarathi R, Widrich J. GOUT. [Online].: StatPearls Publishing; 2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK546606/.

2.

Dehlin M, Lennart J, Edward R. Global epidemiology of gout :prevalence , incidence , treatment patterns and risk factors. [Online].; 2020. Available from: https://doi.org/10.1038/s41584-020-0441-1.

3.

Singh JA, Reddy SG, Kundukalam J. Risk Factor For Gout & Prevention : A Systematic Review of the Literature. [Online].; 2011. Available from: https://journals.lww.com/co-rheumatology/abstract/2011/03000/risk_factors_for_gout_and_prevention__a_systematic.13.aspx.

4.

Nuki G, Simkin PA. A concise history of gout and hyperuricemia and their treatment. [Online].; 2006. Available from: https://pubmed.ncbi.nlm.nih.gov/16820040/.

5.

Mackenzie CR. Gout and Hyperuricemia: an Historical Perspective. [Online].; 2015. Available from: https://doi.org/10.1007/s40674-015-0012-9.

6.

BHATTACHARJEE S. A brief history of gout. [Online].; 2009. Available from: https://pubmed.ncbi.nlm.nih.gov/20374319/.

7.

Golwalla F, Golwalla SA. Golwalla’s medicine for students. 25th ed. Nandkar MY, editor.: Jaypee Brother Medical Publisher; 2017.

8.

Penman ID, Ralston SH, Strachan MW, Hobson RP, editors. DAVIDSON’S PRINICIPLES & PRACTICE OF MEDICINE. 24th ed.: ELSEVIER; 2022.

9.

Ragab G, Elshahaly M, Bardin T. Gout: An old disease in new perspective – A review. [Online].; 2017. Available from: https://pubmed.ncbi.nlm.nih.gov/28748116/.

10.

National Institute of Arthritis and Musculoskeletal and Skin disease. [Online]. Available from: https://www.niams.nih.gov/health-topics/gout/basics/symptoms-causes.

11.

Munjal YP, editor. API TEXTBOOK OF MEDICINE. 9th ed.: The Association Of Medicine; 2012.

12.

Mathew GK, Aggarwal P. MEDICINE : PREP MANUAL FOR UNDERGRADUATES. 5th ed.: Elsevier India.

13.

PHD MD Jameson LJ, Jameson JL, MD Kasper DL, MD Longo DL, MD Fauci AS, MD Hauser SL, et al., editors. Harrison’s Principles of Internal Medicine. 20th ed.: MC GRAW HILL EDUCATION.

14.

MD BRUNETT JC. GOUT & ITS CURE: BOERICKE & TAFEL.; 1895.

15.

Hahnemann S. Organon of medicine. 6th ed.: B JAIN PUBLISHER; 2018.

16.

Sarkar BK. ORGANON OF MEDICINE. 2017th ed.: BIRLA PUBLICIATIONS Pvt Ltd.

17.

Phatak SR. MATERIA MEDICA OF HOMOEOPATHIC MEDICINE. Second edition - revised & enlarged ed.: B JAIN PUBLISHER; 2007.

18.

Boericke W. Boericke’s New Manual of Homeopathic Materia Medica with Repertory. Third Revised & Augmented Edition Based on Ninth Edition ed.: B.Jain Large Print; Third edition (1 April 2010).

19.

MD SL. HOMOEOPATHIC THERAPEUTICS. Second, Revised, & Enlarged Edition ed.: BOERICKE & TAFEL; 1879.

20.

Robert HA. THE RHEUMATIC REMEDIES. 2005th ed.: B JAIN PUBLISHER.

21.

Dalbeth N, Fransen J, Jansen TL, Neogi T, Schumacher HR, Taylor WJ. New classification criteria for gout :a framework for progress. [Online].; 2013. Available from: https://academic.oup.com/rheumatology/article/52/10/1748/1792139.


 
Close