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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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
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 “Intercurrents”.

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 QUESTIONWhether 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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