| CTRI Number |
CTRI/2024/06/068452 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathy in bronchial asthma |
|
Scientific Title of Study
|
Understanding and relevance of intercurrent remedies by Stuart close in cases of bronchial asthma in homoeopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvi Parsotambhai Dhokiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical Collage |
| Address |
Department Of Organon Of Medicine And Philosophy, Rajkot Homoeopathic Medical Collage , Behind Jainath Complex, Makkam chowk, Gondal Road, Rajkot,
Rajkot GUJARAT 360002 India |
| Phone |
7984368480 |
| Fax |
|
| Email |
dr.urvidhokiya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanka J Shroff |
| Designation |
Professor and HOD Of departement of organon of medicine and homoeopathic philosophy |
| Affiliation |
RAJKOT HOMOEOPATHIC MEDICAL COLLAGE |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy, Rajkot Homoeopathic Medical Collage, Behind Jainath Complex,Makkam Chowk, Gondal Road Rajkot.
Rajkot GUJARAT 360002 India |
| Phone |
9898930311 |
| Fax |
|
| Email |
drshroff3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Urvi Parsotambhai Dhokiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical Collage |
| Address |
Department Of Organon Of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic Medical Collage, Behind Jainath Complex, Makkam Chowk Gondal Road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
7984368480 |
| Fax |
|
| Email |
dr.urvidhokiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot homeopathic medical collage,behind jainath complex ,makkam chowk,Rajkot 360002,GUJRAT,India. |
|
|
Primary Sponsor
|
| Name |
Rajkot homeopathic medical collage |
| Address |
Rajkot homeopathic medical collage,behind jainath complex ,makkam chowk,Rajkot,360002,GUJRAT,India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvi Dhokiya |
Rajkot Homoeopathic Medical College |
Department Of Organon Of Medicine And Philosophy, Room Number 103,Rajkot Homoeopathic Medical Collage, Behind Jainath Complex, Makkam Chowk, Gondal Road Rajkot, Rajkot GUJARAT |
7984368480
dr.urvidhokiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research - rajkot homoeopathic medical collage(RHMC), Parul University, Gujrat |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, (2) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVISULIDSED HOMOEOPATHIC MEDICINE |
Individualized homeopathic medicine. Mode of administration: oral (Sublingual) selection of potency, dose and repetition :Individualized homeopathic medicine will be prescribe in 30,200,1m potency and repetition will be according to susceptibility of patient and principles of organon of medicine and follow up every 2 weeks and total duration of intervention is 36 weeks |
| Comparator Agent |
nill |
nill |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)patients of both sexes 2) age group between 15 to 45.3)pre-diagnosed cases which will be fulfilling history and physical findings of bronchial asthma 4)diagnosed case under treatment not controlled and want to shift in homoeopathy. |
|
| ExclusionCriteria |
| Details |
1)patients less then age of 15 and more then age of 45 of both sexes2)patients with complications of bronchial asthma who require oxygen therapy 3)patients with malignant condition. 4)patients with cardiac complications.5)patients under oral and injectable steroids.6) pregnant women |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be some improvement after prescribing intercurrent remedies as homoeopathic medicine and assesement will done by asthma control test. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
reduction of recurrence of asthma attack & break the course of disease by using intercurrent remedies with understanding by stuart close.
To improve quality of life in the patients suffering from bronchial asthma & monitoring for adverse effects of complications
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/09/2024 |
| 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
|
Asthma is chronic inflammatory disease of airway characterized by increased responsiveness of trachea-bronchial tree. Prevalence of asthma increased steadily over latter part of last century, in countries with a western life style and is also increasing in developing countries Asthma is very common it is estimated that 4-5% of population in all countries are affected. The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. The overall burden of asthma in India is estimated at more than 15 million patients. Bronchial asthma occurs at all ages predominantly in early life. About one half of case develops before age 10 and another third occur before age 40. Prevalence of asthma was reported as 2.78% in an urban population aged 30-49 years. In childhood there is 2:1 male/female predominance but sex ratio equalizes by age In modern system of medicine treatment of asthma is through steroids and inhaler. Though there will be temporary relief but biological side effects and complication cannot be ruled out. It is making people more drug dependent . Cases with asthma can be divided into two groups one fresh case with signs symptoms other with drug dependency with continuous allopathic medicine and drugging. Accordingly, Dr. Samuel Hahnemann classification of disease bronchial asthma under dynamic miasmatic chronic disease. But Hahnemann while treating many misfortunate ones noticed that some obstacles are responsible for repeated sufferings After taking case according to case taking criteria given by. Samuel Hahnemann in § 83-104 and form totality of symptoms and give similimum accordingly. But Hahnemann while treating many misfortunate ones noticed that some obstacles are responsible for repeated sufferings After prolonged study, he concluded, in § 3 of Organon of Medicine, that it was nothing but the grotesque shadows of MIASM responsible for these obstacles in permanent cure. It is stated, ’If the physician clearly perceives what is to be cured in diseases, that is to say, if he knows the obstacles to recovery in each case and is aware of how to remove them, so that the restoration may be permanent, he must clearly define how to deal with those obstacles and be aware of it. The law of similar defines what is cure, while the miasm defines what is to be cured in the man in disease. So to find out the reason behind bronchial asthma miasm is prime importance. "The organism, indeed the material instrument of life, is not conceivable without the animation imparted to it by the instinctively perceiving and regulating vital force; thus, the two together constitute a unity, although in thought our mind separates this unity into two distinct conceptions for the sake of easy comprehension." After similimum sometime disease in stand still position and cases where the latent diseases represented by these medicines are present, as shown by the existent symptoms or by the history and previous symptoms of the case so, Remedies used in this way are known as “Intercurrentsâ€. After using knowledge of posology from § 245-246,275-276 and knowledge of second prescription from § 272-277 totality of symptoms remain same after given similimum disease in stand still position no improvement further at that time indicated remedy that represent existence symptoms or by the history and previous symptoms of the disease after such indicated remedy as intercurrent gives better result in disease. In Chronic disease like bronchial asthma while patient came again and again with same symptomatology without result after consider totality of symptoms according to § 5 at that time using intercurrent remedies is very useful to remove that latent phase of disease and decrease relapses. RESEARCH QUESTION : Whether intercurrent remedies of stuart close is useful in management of cases of bronchial asthma in homoeopathy? NULL HYPOTHESIS : Intercurrent remedies of stuart close is not useful in the management of bronchial asthma in homoeopathy. ALTERNATIVE HYPOTHESIS : Intercurrent remedies of stuart close is useful in the management of bronchial asthma in homoeopathy
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