| CTRI Number |
CTRI/2024/05/066693 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Homoeopathic Medicine in the Treatment of Gastroesophageal Reflux Disease. |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in Comparison with Quassia amara 30C in the Treatment of Gastroesophageal Reflux Disease: A Double Blind Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jagannath Meher |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO -18, National Institute of Homoeopathy, GE Block, Salt Lake, Sector III, Kolkata, West Bengal, 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9668146443 |
| Fax |
|
| Email |
jagannathmeher66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Prasanta Rath |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
HOD, Department of Community Medicine, National Institute of Homoeopathy, GE Block, Salt Lake, Sector III, Kolkata, West Bengal, 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Dr. Prasanta Rath |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
HOD, Department of Community Medicine, National Institute of Homoeopathy, GE Block, Salt Lake, Sector III, Kolkata, West Bengal, 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block, Sector III, Salt lake, Kolkata, West Bengal, 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, GE Block, Salt Lake, Sector III, Kolkata, West Bengal, 700106 |
| Type of Sponsor |
Government 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 |
| DrJagannath Meher |
National Institute of Homoeopathy |
Room no-18, Department of Homoeopathic Materia Medica,National Institute of Homoeopathy, GE Block, Sector-III, Salt Lake , 700106,Kolkata, West Bengal
North Twentyfour Parganas
WEST BENGAL |
9668146443
jagannathmeher66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K21||Gastro-esophageal reflux disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine to be selected after complete case taking. Potency, Dose and frequency of the selected medicine will be as per susceptibility of the patient. Follow will be done monthly till 3 months from the baseline. |
| Intervention |
Quiassia amara 30C |
Potency 30C will be given, dose and frequency of medicine will be as per the susceptibility of the patient. Follow up will be done monthly till 3 months from the baseline. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from GERD diagnosed clinically and by GERD Questionnaire (GERD Q).
2.Patients aged between 20 to 65 years.
3.Patients of both sexes, all religions, and of different socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Patients who aren’t willing to lifestyle modification.
3.Patients having complications of GERD like dysphagia, food impaction, etc.
4.Patients having any terminal disease condition like cancer, end-stage renal disease, etc.
5.Patients not willing to take part in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare changes in the GERD Health-Related Quality of Life (GERD- HRQL) Questionnaire score in the patient suffering from GERD treated with Individualized Homoeopathic Medicine and Quassia amara-30C over 3 months. |
baseline and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare changes in the Perceived Stress Scale (PSS) score in the patient suffering from GERD treated with Individualized Homoeopathic Medicine and Quassia amara-30C over 3 months. |
Baseline and 3 month |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
27/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Gastroesophageal reflux disease is a common condition causing uncomfortable symptoms. GERD can cause a wide variety of symptoms ranging from heartburn and regurgitation to more atypical symptoms such as cough, chest pain, and hoarseness. In old school Quassia amara bark was used for dyspepsia. Boericke mentions in his Materia Medica that it acts on the gastric organs as a tonic. Heartburn and gastralgia, regurgitation of food ,but no study paper available in Homoeopathy that proves its efficacy .So i will screen patients of GERD with no other complications of GERD. For one intervention group 41 patients i will give Quassia amara 30C and other 41 patients will take Individualized Homoeopathic treatment those who are attending NIH OPD & IPD, Kolkata. Study period will be 18 months and intervention period will be 3 months. After study i will compare GERD Health Related Quality of Life(GERD-HRQL) Questionnaire score and Perceived Stress Scale(PSS) Score in both Quassia and Individualized Homoeopathic Medicine group. Patient will be enrolled after informed consent only available in Hindi, English and Bengali languages. If any negative outcomes appears for deterioration of health condition of patients then study will be stopped and necessary measures for the betterment of patient will be taken. |