| 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
|
|
|
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
|
|
|
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. |