| 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
|
|
|
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
|
|
|
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.
|