| CTRI Number |
CTRI/2024/12/078653 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Kents Repertory Helps Treat Kidney Stones with Homoeopathy |
|
Scientific Title of Study
|
Utility of Kents Repertory in cases of Renal stone |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fenil Jagdishkumar Miyani |
| Designation |
M.D. Scholar part - 2 |
| Affiliation |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat GUJARAT 395001 India |
| Phone |
8160181397 |
| Fax |
|
| Email |
fenilmiyani000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dhaivat Upadhyay |
| Designation |
Associate Professor Department Of Case Taking And Repertory |
| Affiliation |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat GUJARAT 395001 India |
| Phone |
9033764079 |
| Fax |
|
| Email |
udhaivat@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dhaivat Upadhyay |
| Designation |
Associate Professor Department Of Case Taking And Repertory |
| Affiliation |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat GUJARAT 395001 India |
| Phone |
9033764079 |
| Fax |
|
| Email |
udhaivat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar college of homoeopathic medicine and Hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Fenil Jagdishkumar Miyani |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat Surat GUJARAT |
8160181397
fenilmiyani000@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 Hopsital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicine As Per Requirement Of Case Through Sublingual mode of Administration within time duration of 9 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Renal stone size less than 12mm. |
|
| ExclusionCriteria |
| Details |
Renal stone size more than 12mm.
patient come with complication like pyelonephritis, hydronephrosis, calculous anuria, chronic renal failure, scarring, abscess and any other life threatening complication.
patient with any pathological disease, critically ill cases which required hospitalization. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To remove Symptoms Of Patients |
Removal Of Symptoms Of Renal Stone Depends On The Condition Of The Patients Probably 25 To 30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Relief The Patient From Renal Stone And Also Relieving From Recurring Tendency Of Renal Stone |
To Improve The Pain of patients within 2 months & after that will assessed recurrency of Renal Stone episode within 9 months. |
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2025 |
| 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
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Brief Summary
|
|
| BRIEF RESUME OF INTENDED WORK: | |
| NEED FOR STUDY: In present times, many people are having unhealthy lifestyle such as inappropriate diets, sedentary habits and inadequate hydration, this type of lifestyle leads to various health issues, including vitamin deficiency, weight gain and other medical conditions. Among these, renal stones are very common condition. National health and Nutrition Examination Survey data indicate that up to 19% of men and 9% of women will develop at least one stone during their lifetime. Depending on the size of renal stone, some are treated with medication, while others require surgery. Some individuals are afraid to the surgical process, and simultaneously, surgical treatment is also very expensive. In India, many people do not have good socio-economic conditions, so they cannot afford surgery. Those who are hesitant about surgical interventions, may choose homeopathy as an alternative. Homeopathic treatment does not require any surgery in cases of renal stone and it is more affordable compared to surgery. In case of recurrent occurrence, renal stones are not easily removed by cesarean section or lithotripsy. Homeopathy not only cure the disease but also prevent their recurrence. | |
| REVIEW OF LITERATURE: INTRODUCTION The term ‘nephrolithiasis’ is derived from the Greek words ‘Nephros’ which means ‘kidney’ and ‘Lithos’ which means ‘stone’. Nephrolithiasis is common worldwide; this is the third commonest disorder of the urinary tract after urinary tract infection and prostatic hyperplasia. (1) EPIDEMIOLOGY In India, maximum prevalence occurs in Jammu and Kashmir, Punjab, Haryana, Delhi, Rajasthan, Madhya Pradesh and Gujarat. Peak age is 20 to 30years. Recurrence is common; it is 15% at one year, 30 to 40% at 5 years and 50% at 10 years. (1) PATHOGENESIS Normal urine contains both solvents and solutes; imbalance of their relative concentrations results in precipitation of solutes leading to pathological crystallisation which occurs in three stages: stage 1 “under saturation†when | | | crystals remain dissolved; stage 2 “saturation†in which urine is saturated with crystals; stage 3 “super saturation†when urine becomes oversaturated with crystals. ‘Nucleation’ is an important initial step, followed by crystal aggregation and stone formation. (1) RISK FACTORS 1)Dietary factors that are associated with an increased risk of nephrolithiasis include animal protein, oxalate, sodium, sucrose, and fructose. (2) 2)Higher intake of supplemental calcium. (2) 3)Higher intake of animal protein. (2) 4)Intake of vitamin c supplements. (2) 5)Decreased urine output. (2) 6)Urinary stasis. (3) 7)Deficiency of vitamin A. (3) 8)Renal infection. (3) TYPES OF RENAL STONES 1)Oxalate stone :- It is most common type of renal stones and accounts for 70% of all renal stones. Irregular, sharp projection may lead to haematuria, Radioopaque. (3) 2)Phosphate stone :- They are form in alkaline urine. Soft, gray-white. They are large and fill most of collecting system, forming “stag-horn stoneâ€. Radiopaque. (3) 3)Uric acid and Urate stone :- They are form in acidic urine. Hard, smooth, multiple and yellow in colour. Radiolucent. (3) 4)Cystine stone :- They are form in acidic urine. Hard, multiple. Radiopaque. (3) 5)Xanthine stone :- They are smooth, brick red in colour. Radiolucent. (3) CLINICAL FEATURES 1)Large staghorn stones are usually asymptomatic. (3) 2)Haematuria. (3) 3)Pain felt at renal angle. (3) 4)Pyuria. (3) 5)Common presentation is renal or ureteric colic; acute loin pain radiating to the groin with nausea and vomiting. (1) 6)Stone moving down the ureter causes intermittent ureteric obstruction with acute colicky pain. (1) 7)Urgency, frequency, strangury occur with stone at ureter ovesical junction. (1) 8)Presence of fever indicates the infection. (1) | | | INVESTIGATION 1)Urine examination (3) 2)Blood examination (3) 3)Renal function test (3) 4)Plain X-ray (3) 5)Ultrasonography (3) 6)CT Scan (3) Homeopathy is a system of alternative medicine that was developed in the late 18th century by Samuel Hahnemann. It is based on the principle of “like cures likeâ€. Clinical practice in homeopathic system of medicine is based upon the integration of Homeopathic Materia Medica, Organon of Medicine & Repertory. Each of the discipline has it’s own importance but at the same time they are so intimately related to each other that it become difficult to practice homeopathy if any one of these three discipline is not understand properly. Amongst these three, Repertory is an importance tool to find the similimum, each repertory has its own artistic way of presentation, which enables the physician to get best result if used properly by understanding that repertory. (4) KENT’S REPERTORY Repertory of Homeopathic Materia Medica was published by Dr. J.T. Kent in 1897. Kent’s repertory is based on the philosophy of deductive logic that is from GENERAL TO PARTICULAR. (5) (4) TYPOGRAPHY | BOLD LETTR | 3 marks | First grade | | Italic letter | 2 marks | Second grade | | Roman letter | 1 marks | Third grade | (5) (4) Total no. of chapters- 37 chapters. (5) (4) It starts with MIND chapter and ends with GENERALITIES chapter. (5) (4) Total no. of medicine- 648 medicines. (5) (4) ARRANGEMENT OF RUBRICS All rubrics are arranged alphabetically in all the chapters. Rubrics are arranged from general to particulars. (5) (4) | | | Rubric starts with a general symptom or a state with a list of large group of medicines. This is followed by side, time, modality and extension. (5) (4) Side: whenever rubric can be divided into side, general rubric is followed immediately by side, firstly right side than left side. (5) (4) Time: Here also Kent follows logic of general to particulars. Day time Morning Forenoon Noon Afternoon Evening Twilight Night Midnight After midnight (5) (4) Modalities: they are arranged as follows: Ailments from Alternating with Modifying factors, aggravation, amelioration. (5) (4) Extension: this is the last subrubric (5) (4) | |
| OBJECTIVE OF THE STUDY: • To study the utility of “Repertory of homeopathic material medica by Dr. J.T. Kent†in management of cases of renal stones. • To find utility of homeopathic medicines in cases of renal stone with the help of “Repertory of homeopathic material medica by Dr. J.T. Kent.†| |
| MATERIAL AND METHODS: | |
| SOURCES OF DATA: PROJECT SITE – OPD & IPD of C. D. Pachchigar College of Homoeopathic Medicine & Hospital; Near Navjivan Circle, Udhana Magdalla Road, Surat. 395001 | |
| MATERIALS: 1. Case performa prepared for C.D. Pachchigar General Hospital O.P.D. 2. Kent’s repertory. 3. Homoeopathic computerized software: Zomeo software version 13.8.0 4. Repertorization sheet. 5. Book of organon of medicine, philosophy, material medica, repertory, all homoeopathic books & literature related to my topic, software & soft or hard research material. | |
| METHOD OF COLLECTION OF DATA: 1. Study design – Prospective Analytical study 2. Study population – 100 cases of renal stone treated with help of Kent’s repertory. 3. Sample size – 30 cases. 4. Sampling techniques-simple randomization. 5. Selection criteria. Inclusion criteria: 1. Patient’s age between 20 to 60 years, in both sexes. 2. Renal stone size less than 12 mm. Exclusion criteria: 1. Patient’s age less than 20 years and more than 60 years. 2. Renal stone size more than 12mm. 3. Patient comes with complication like pyelonephritis, hydronephrosis, calculous anuria, malignancy, chronic renal failure, scarring, abscess and any other life threatening complication. 4. Patient with any pathological disease, critically ill cases which required hospitalization. | | | • Patient is selected on basis of inclusion & exclusion criteria, history & clinical finding. • Case taking will be done according to guidelines mentioned by Dr. Hahnemann in Aphorisms 83-104. • After proper analysis and evaluation of symptoms, totality of symptoms will be formed. • Repertorization will be done by using Kent’s Repertory from zomeo software version 13.8.0. • Totality formation will be done as per the instructions given by Dr. Hahnemann in organon of medicine. • Investigations for diagnosis of the disease will be done as per the requirement of the case. • The remedies will be used in various potency as per the requirement of the case. • Remedies will be administered as per guidelines given by Dr. Hahnemann in organon of medicine. • The remedies will be repeated as per the requirement of the case, on the basis of teachings by Dr. Hahnemann in Organon of medicine. • Homoeopathic remedies will be dispensed from C.D. PACHCHIGAR college & hospital homoeopathic pharmacy as per the guidelines of master Hahnemann advised in organon of medicine. Response was analysed as per following criteria’s: 1. Significant Improvement: disappearance of all sign and symptoms with no relapse for 3 months. 2. Improvement: decreased in intensity and/or frequency of presenting complaints with feeling of well being. 3. No improvement: neither increase nor decrease in symptoms of the patient or worse condition of patient. | |
| DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? | As per requirement of the case | |
| HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE? | YES | |
| BIBLIOGRAPHY: | | | 1. Munjal YP. API Textbook of Medicine. Ninth ed. Mumbai: Association of Physicians of India; 2012. 2. Harrison TR. Harrison’s Principles of Internal Medicine. Twenty first ed. New York: Mcgraw-Hill Medical; 2022. 3. Naseem A. A Concise Textbook of Surgery. 2nd ed. Gorakhpur: Pulse Publication; 2014. 4. Tiwari SK. Essentials of Repertorization. 5th ed.: B Jain Pub Pvt Limited; 2012. 5. Mohanty DN. Evolution/Unfolding of Homeopathic Repertories. 1st ed. New Delhi: Indian Books & Periodicals Publishers; 2005. 6. Kent JT. Repertory of the Homoeopathic Materia Medica. 6th ed. Kent CL, editor.: B Jain Publishers; 2002. | |