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CTRI Number  CTRI/2025/01/079064 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homeopathic treatment of Functional Dyspepsia 
Scientific Title of Study   The role of individualized homeopathic medicine in treatment of Functional Dyspepsia 
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 Ruchishree Panda  
Designation  PGT Department of Practice of Medicine 
Affiliation  RBTS Govt Homoeopathic Medical college and hospital 
Address  Room Number 03 Academic block RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Room Number 03 Academic block RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India 
Phone  9668426838  
Fax    
Email  henapanda1603@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ruchishree Panda  
Designation  PGT DEPARTMENT OF PRACTICE OF MEDICINE 
Affiliation  RBTS Govt Homoeopathic Medical college and hospital 
Address  Room Number 03 Academic block RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Room Number 03 Academic block RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India 
Phone  9668426838  
Fax    
Email  henapanda1603@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Haresh Kumar Maharaj 
Designation  Associate Professor Department of Practice of Medicine 
Affiliation  RBTS Govt Homoeopathic Medical college and hospital 
Address  Room Number 03 Academic block RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Room Number 03 Academic block RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India 
Phone  7903899078  
Fax    
Email  drhareshkumarmaharaj@gmail.com  
 
Source of Monetary or Material Support  
RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar 842002 INDIA 
 
Primary Sponsor  
Name  RBTS GOVT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  MUZAFFARPUR BIHAR INDIA 842002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Haresh Kumar Maharaj   RBTS Govt Homoeopathic medical college and hospital  OPD1 OPD 3 OPD 6 AND IPD hospital block RBTS Govt Homoeopathic Medical College and Hospital
Muzaffarpur
BIHAR 
7903899078

drhareshkumarmaharaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE RBTS GOVT HOMOEOPATHIC MEDICAL COLLEGE AND HOPSITAL MUZAFFARPUR BIHAR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic medicine   Selected medicine will be given in 30 200 1m potency and follow up should be done at 15 days interval for about 1 to 3 months 
Comparator Agent  NOT APPLICABLE   NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient willing to participate in the study
Patient of age group between 20 to 50 years
Patient of both sexes, all religion and from different socioeconomic status
Self-reported & pre-diagnosed cases of functional dyspepsia.
Patients with symptomatology of functional dyspepsia fulfilling Romes criteria IV .
 
 
ExclusionCriteria 
Details  Age below 20 years and above 50 years
Diagnosed cases of systemic diseases, immunocompromised states, psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
Advance pathology of GIT like Inflammatory bowel diseases, Intestinal Obstruction, GIT polyp, malignancy, surgical cases, was not be included in studies
Pregnancy and lactation.
Substance abuse and/ or dependence.
Those patients who have not given their consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At the end of the study, it is expected that constitutional homoeopathic medicine i.e. medicine selected on the basis of totality of the symptoms when prepared and administered according to the homoeopathic principles acts curatively, relieving functional dyspepsia gradually and thereby preventing the recurrence and complications  4 Weeks to 12 Weeks  
 
Secondary Outcome  
Outcome  TimePoints 
2. This will encourage the patients for promoting homoeopathic management over the use of proton pump inhibitors, H2-receptor antagonists, prokinetic agents, and antidepressants for management of functional dyspepsia.  1 to 3 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 4 
Date of First Enrollment (India)   05/02/2025 
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="6"
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  

 

Dyspepsia is a recurrent burning discomfort or pain in the upper abdomen a heterogenous category that include disorder of motility, sensation and somatization. Functional dyspepsia is one of the most prevalent functional gastrointestinal disorders. The condition has 3 subtypes—epigastric pain syndrome, postprandial distress syndrome (PDS), and a combination of both—each thought to result from different mechanisms. Diagnosis is based on the Rome IV criteria, which define functional dyspepsia as the presence of one or more symptoms, such as epigastric pain, burning, early satiety, and postprandial fullness, and in the absence of structural disease detectable by imaging or endoscopy. In R.B.T.S Govt. Homoeopathic Medical College & Hospital OPD, there are numerous patients visiting regularly seeking treatment of dyspepsia. No other previous researches on functional dyspepsia under Rome IV criteria has been done. Homeopathy is a holistic system of medicine in which a person is treated in accordance to totality of symptoms. The most characteristic symptom is a holistic guide to finding the patient’s specific homeopathic treatment done under principle of individualization. So, this institution is the best platform to perform such kind of study and research. I hope my Research topic will add more input on this disease and will prove helpful to patient seeking treatment of dyspepsia.


 
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