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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  
Status 
Not Applicable 
 
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.
 
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