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CTRI Number  CTRI/2014/02/004426 [Registered on: 21/02/2014] Trial Registered Prospectively
Last Modified On: 27/01/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   homoeopathic treatment of acid reflux 
Scientific Title of Study   An open label (pre and post- homoeopathic intervention) study to evaluate efficacy of homoeopathic treatment of Non erosive gastro esophageal reflux disease  
Trial Acronym  NEGERD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R K Manchanda 
Designation  Director General 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Opp. D-Block, Janakpuri, Delhi South West Delhi

South West
DELHI
110058
India 
Phone  01128525523  
Fax  01128521060  
Email  dgccrh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Khurana 
Designation  Assistant Director 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Janakpuri, Delhi South West Delhi

South West
DELHI
110058
India 
Phone  01128525749  
Fax  01128521060  
Email  ccrhindia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anil Khurana 
Designation  Assistant Director 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Janakpuri, Delhi South West Delhi


DELHI
110058
India 
Phone  01128525749  
Fax  01128521060  
Email  ccrhindia@gmail.com  
 
Source of Monetary or Material Support  
Approved budget of CCRH 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Janakpuri, Delhi  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amitava Poddar  Central Research Institute (Homoeopathy)  In front of Samphel Hotel, Near Sangram Bhawan, Development Area, Gangtok -737101
North
SIKKIM 		 09832500169

poddar.amitava33@gmail.com 
Dr M D Arya  Central Research Institute (Homoeopathy)  A-1/1, Sector 24, Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 09999369295

mdarya01@gmail.com 
Dr M S Ghosh  Central Research Institute (Homoeopathy)  1/4 Main Road, Colonel Chowmuhani, Krishnagar, P.O. Agartala-799001
West Tripura
TRIPURA 		 09436997482

drmsghosh@in.com 
Dr U K Prusty  Clinical Research Unit (H)  Dhankheti, Near Shillong Law College, Shillong-793001
East Khasi Hills
MEGHALAYA 		 09485025977

druprusty@gmail.com 
Dr P K Chandra  Regional Research Institute (Homoeopathy)  50, Rajendra Chaterjee Road, Kolkata-700035
Kolkata
WEST BENGAL 		 09432288171

drpkchandra@gmail.com 
Dr Ramesh S Bawaskar  Regional Research Institute (Homoeopathy)  "MTNL" Hall No.4, Shopping Centre, Sector-9,CBD Belapur, Navi Mumbai- 400614
Mumbai (Suburban)
MAHARASHTRA 		 09769888743

drbrsb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of CCRH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Non erosive gastro-esophageal reflux disease ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine  Individualized homoeopathic medicine for 56 days as per the need of the patient 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  62.00 Year(s)
Gender  Both 
Details   Patient presenting with heartburn & regurgitation with symptom score of more than 4 with normal endoscopic finding.
 Patient having history of heart burn & regurgitation for 6 weeks with minimum of 2 episodes in a week.
 
 
ExclusionCriteria 
Details   Pregnancy or lactation period.
 Patients having:
 Dysphagia or associated alarm symptoms like gastrointestinal hemorrhage, mechanical obstruction or perforation.
 Peptic ulcer disease.
 Severe cardiac, pulmonary, hepatic or renal disease.
 Presence of gall stone disease.
 Patient on concomitant medications known to affect the treatment response or recent h/o consumption of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs), Proton Pump Inhibitors and histamine 2-receptor antagonists within the previous 15 days.
 Patients with history of previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
 Improvement in GERD -based symptom score from baseline to end of treatment.
 Resolution of symptoms in terms of severity and frequency.
 To assess the quality of life by WHO-QOL BREF.
 		 the outcome will be assessed at 56th week(at the end of treatment)
 
 
Secondary Outcome  
Outcome  TimePoints 
To deduce symptom of the drugs found effective.  At the end of study 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/03/2014 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published as per the publication policy of the Council 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The study will be conducted with an objective to find out the usefullness of the Homoeopathic medicine in the treatment of Non erosive gastro-esophageal reflux disease. 30 patients between the age group of 18 years to 62 years presenting with two major symptoms i.e. hegurgitation and heartburn with symptom score more than 4 and having normal endoscopic findings will be enrolled during the study. The study is multicentric open label pre-post homoeopathic intervention where individualized homoeopathic medicine will be given and patients will be assessed on weekly basis till 8 weeks. The outcome will be measured  in terms of improvement in GERD-based symptom score baseline to end of treatment, resolution of symptom in terms of severity and frequency, quality of life using WHO-QOL BREF and relief in pain will be assessed by VAS score. 
 
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