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CTRI Number  CTRI/2024/06/069333 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study
Modification(s)  
Homoeopathy in Gastroesophageal Reflux Disease 
Scientific Title of Study   Utility of Synthesis Repertory in management of cases of GERD and Preparation of Repertory of GERD and Therapeutics for the same 
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 Palak M Parmar 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case Taking and Repertory, Rajkot Homoeopathic Medical College, Behind Jainath complex, Makkam chowk, Gondak Road, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9978494979  
Fax    
Email  palak_parmar13@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. kashyap R Premasawala 
Designation  HOD 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, Behind Jainath complex, Makkam chowk, Gondal Road, Rajkot.

Rajkot
GUJARAT
360002
India 
Phone  9727173799  
Fax    
Email  K2Krp@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Palak M Parmar 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case Taking and Repertory, Rajkot Homoeopathic Medical College, Behind Jainath complex, Makkam chowk, Gondal Road, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9978494979  
Fax    
Email  palak_parmar13@yahoo.com  
 
Source of Monetary or Material Support  
Rajkot Homoeopathic Medical College, Behind Jainath Complex. Makkam Chowk, Gondal Road, Rajkot - 360002 Gujarat India 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College, Parul University 
Address  Department of Case Taking and Repertory, Rajkot Homoeopathic Medical College, Behind Jainath Complex, Makkam Chowk, Gondal Road, Rajkot - 360002 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 Palak M Parmar  Rajkot Homoeopathic Medical College  Department of Case taking and Repertory Behind Jainath Complex Makkam Chowk Gondal Road Rajkot 360002
Rajkot
GUJARAT 
9978494979

palak_parmar13@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individulised Homoeopathic Medicine  Individualized Homoeopathic medicine selected using Synthesis Repertory. Mode of Administration: Oral(sublingual) Selection of potency, dose and repetition: Individualized medicine will be prescribed in 30, 200, 1M potency. Selection of dosage, potency and repetition will be according to susceptibility of patient and principles of Organon of medicine. Total duration of Intervention will be 9 months 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patients from age group of 18 to 70 will be considered
2) Patients of both sexes and all socio-economical classes irrespective of cast and religion will be considered
3) Patient with GERD Q score ≥ 8 will be considered for study
4) Pre-diagnosed cases of GERD
 
 
ExclusionCriteria 
Details  1) cases with pathological changes like Barrate’s oesophagus, carcinoma of oesophagus and pure surgical cases etc are excluded.
2) Patients suffering from life threatening disease and those who require emergency medical intervention are excluded from the study.
 
 
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 Homoeopathic Medicines. Assessment will be done using FSSG (Frequency scale for the symptoms of GERD).   There will be some improvement after prescribing Homoeopathic Medicines after 15days, 30 days, 45days 
 
Secondary Outcome  
Outcome  TimePoints 
Marked improvement:-Feeling of well-being in both mental & physical level with disappearance or diminution of most of signs & symptoms for which patient came to us, without any relapse or recurrence during the study duration.(76 -100 %)
Moderate improvement:- relief in symptoms with decrease in frequency & intensity of symptoms (51 - 75 %)
Mild improvement :- partially relief in symptoms with no marked improvement (26 - 50 %)
Status quo :- patient remains in as it is condition even after administration of homoeopathic similimum (0 - 25% )
 
There will be some improvement after prescribing Homoeopathic medicines after 9 months 
 
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/ Phase 3 
Date of First Enrollment (India)   01/10/2024 
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  

             Gastroesophagealreflux disease (GERD) is a common disorder of the upper gastrointestinal tract that is typically characterized by heartburn and acid regurgitation. GERD is a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. GERD is a chronic disease that tends to relapse and cause complications. The risk factors in patients with GERD include older age, obesity, hiatal hernia, stress/anxiety and an unhealthy lifestyle, including alcohol consumption and cigarette smoking.

             GERD has an impact on the daily lives of affected individuals, interfering with physical activity, impairing social functioning, disturbing sleep and reducing productivity at work.Due to its recurrent and troublesome symptoms and complications, GERD seriously lowers patients’ health-related quality of life. Besides, due to its chronic nature and high prevalence, GERD has imposed a significant economic burden on patients and their families, health services, and society. The clinical management of GERD influences the lives of many individuals and is responsible for the substantial consumption of health care and societal resources.

             According to GBD study, the number of prevalent cases of GERD increased by 77.53% from 441.57 million in 1990 to 783.95 million in 2019.The prevalence of GERD in India ranges from 7.6% to 30%.

            Nowadays we are seeing many patients who show no significant relief or decrease in symptoms even after the continuous conventional treatment. Our homoeopathic system is efficient to give the significant & satisfactory improvement to the patients as an adjuvant therapy & as an individual method too. In present time Repertory has become an indispensable aid to Homoeopathic practitioners.

            Synthesis Repertory is the latest among all repertories. This Repertory has set a new standard by adding many information and continuous verification by its users. It encompasses a wide range of symptoms making it comprehensive for all type of case analysis. The Synthesis Repertory is regularly updated with new information and additions, ensuring it remains current and relevant to contemporary homoeopathic practice.

            In this study I will attempt to show the utility of Synthesis repertory (version 9.1) in the management of GERD. Apart from this I will also try to prepare a handy repertory of GERD  and also extraction of therapeutics of chief remedies and specific remedies in order to create a better understanding of their effectiveness for GERD.

 

 
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