| CTRI Number |
CTRI/2024/12/077660 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic treatment in Gastric reflux disease |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Treatment in Gastroesophageal Reflux Disease using GERD Questionnaire |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shameer Nawaz S |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College And Hospital |
| Address |
Department of Organon of medicine Opd Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem TAMIL NADU 636308 India |
| Phone |
8248380972 |
| Fax |
|
| Email |
nawazshameer228@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr P Santi Dheepan |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College And Hospital |
| Address |
Department of Organon of medicine Opd Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem TAMIL NADU 636308 India |
| Phone |
9986076195 |
| Fax |
|
| Email |
Santiagobear93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr P Santi Dheepan |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College And Hospital |
| Address |
Department of Organon of medicine Opd Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem TAMIL NADU 636308 India |
| Phone |
9986076195 |
| Fax |
|
| Email |
Santiagobear93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Homoeopathic Medical College and Hospital
NH47 Sankari Main road Seeragapadi Salem
Tamilnadu India 636308
|
|
|
Primary Sponsor
|
| Name |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
NH47 Sankari Main Road Seeragapadi Salem Tamilnadu India 636308 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
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 Shameer Nawaz S |
Vinayaka Mission Homoeopathic Medical College And Hospital |
Department of Organon of Medicine Opd room 2e1 Vinayaka Mission Homoeopathic Medical College And Hospital
NH47 Sankari Main Road Seeragapadi
Salem
636308
Salem TAMIL NADU |
8248380972
nawazshameer228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Medicines are selected on the basis of individualisation and symptom similarity and potency is selected on the basis of patient susceptibility |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms of Heartburn and or regurgitation for minimum of six weeks and at least two episodes per week and GERDQ score of 8 and more |
|
| ExclusionCriteria |
| Details |
Patients with history of gastric surgery
Patients with cardiac, pulmonary, hepatic or renal diseases.
Pregnant and lactating women
Patients with autoimmune diseases
Patients with alarming symptoms such as severe dysphagia, hematemesis, anemia, acute weight loss,nausea and incessant vomiting. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in GERD symptoms
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in GERD Questionnaire score |
6 months |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Gastro-oesophageal reflux disease( GERD) is a commonly prevailing disease in the recent times owing to the fast paced urbanized way of living where emphasis on proper diet and lifestyle has been constantly being overlooked. Gastro-oesophageal reflux disease is identified by the presence of characteristic symptoms of heartburn, regurgitation of ingested food or acidic regurgitation and upper abdominal pain, in some cases presence of chronic cough and difficulty in swallowing is observed. Owing to the uncertainty in availability of invasive tests in primary care units, patient’s discomfort and high financial requirement of endoscopic studies, the need of non-invasive diagnostic measures such as scales and questionnaires have raised.A need arises to minimise the usage of invasive measures and at the same time to arrive at a satisfactory diagnosis. Various approaches have been devised to diagnose GERD without resorting to invasive procedures. Questionnaires represent one such method, enabling an objective evaluation of symptoms. These questionnaires typically comprise a series of inquiries to gauge severity (often utilizing scales like Likert’s scale), frequency, associated phenomena, nighttime symptoms, and occasionally quality of life. The benefits of questionnaires lie in their self-administration capability, utility as screening instruments, affordability, and applicability to any individual experiencing GERD symptoms. Based on the DIAMOND ROC analysis, logistic regression and relevance, as well as data from previous studies and qualitative interviews, six items from the different questionnaires were included in the new questionnaire, GerdQ contains 6 questions, which comprises four positive predictors of GERD: heartburn and regurgitation (the two characteristic symptoms of GERD, according to the Montreal definition), sleep disturbance because of these two reflux symptoms and two negative predictors of GERD, epigastric pain and nausea. Patients were asked to reflect on symptoms over the preceding week. Scores ranging from 0 to 3 were applied for the positive predictors and 10from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18.The Homoeopathic medicine will be prescribed on the basis of Constitutional totality followed by scoring in GERD Questionnaire. |