| CTRI Number |
CTRI/2025/11/096882 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on The Effect of Homoeopathic Treatment in Non-Alcoholic Fatty Liver Disease. |
|
Scientific Title of Study
|
Comparative Study on The Effect of Individualised Homoeopathic Medicine Versus Placebo in Treatment of Non-Alcoholic Fatty Liver Disease: An Interventional Study. |
| 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 Kausthab Dey |
| Designation |
Post Graduate Trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine ( 1st floor), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Sailen manna sarani ( Drainage Canal Road), Dumurjola, Howrah-711104
Haora
WEST BENGAL
711104
India |
| Phone |
6289053001 |
| Fax |
|
| Email |
kausthabdey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saptarshi Choudhury |
| Designation |
Professor and Head, Department of Practice of Medicine |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine ( 1st floor), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Sailen manna sarani ( Drainage Canal Road), Dumurjola, Howrah-711104
Haora
WEST BENGAL
711104
India |
| Phone |
9836080877 |
| Fax |
|
| Email |
drcsaptarshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saptarshi Choudhury |
| Designation |
Professor and Head, Department of Practice of Medicine |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine ( 1st floor), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Sailen manna sarani ( Drainage Canal Road), Dumurjola, Howrah-711104
Haora
WEST BENGAL
711104
India |
| Phone |
9836080877 |
| Fax |
|
| Email |
drcsaptarshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Sailen Manna Sarani( Drainage Canal Road),Dumurjola, Howrah-711104 |
| 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 Kausthab Dey |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Practice of Medicine, OPD room no. 1,2,3,7,8,4,10, PG OPD room no. 11 and IPD of Male and Female, Emergency, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Sailen manna sarani ( Drainage Canal Road), dumurjola, Howrah- 711104
Haora
WEST BENGAL |
6289053001
kausthabdey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Intervention is planned as administering indicated Individualised homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition in centesimal scale, each dose will consist of of four cane sugar globules no. 20 moistened with individualised homoeopathic medicine, to be taken orally on clean tongue in empty stomach as per homoeopathic principles as laid by master Hahnemann and dosages and repetition of doses will be followed as per the requirement of each case as per direction of organon of medicine. Homoeopathic medicines will be dispensed from dispensary of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Patients will be advised to refrain from handling the globules and will be advised to refrain from taking foods which may alter the action of homoeopathic medicine as directed by master Hahnemann. Medicines will be procured from a good manufacturing Practice (GMP) certified firm. Along with I.H.M. Patient will receive concomitant care with yoga and proper dietary advice. follow up with intervention will be continued for six months for each case. |
| Comparator Agent |
Placebo |
placebo, indistinguishable in appearance from homoeopathic medicine. Each dose of placebo will be consist of four globules as identical in appearance as globules of individualised homoeopathic medicine, to be taken orally on clean tongue with empty stomach; dosage and repetition of dosage will be as per the requirement of each case, as direction given in organon of medicine. Placebo will be dispensed from dispensary of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Patients will be advised to refrain from handling the globules. Along with placebo patients will receive concomitant care with yoga and proper dietary advice. duration of comparator agent with follow up is same as intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients attending OPD’s and IPD of MBHMCH, diagnosed with non-alcoholic fatty liver disease with hepatomegaly grade 1 or grade 2, by ultrasonography done within last three months from the day of first visit.
2.Patient willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patient Having Grade 3 Fatty Liver.
2. Patient having Cirrhotic Changes.
3.Patient of End Stage Liver Disease.
4. Terminally Ill Patient.
5. Patients with Any Kind of Substance Abuse.
6. Patient Diagnosed with Psychological Illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fib-4 scorring and measuring serum alanine aminotransferase (ALT) |
At every two months after, three times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography of whole abdomen |
At baseline or under three months before enrollment and after 6 months. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
14/11/2025 |
| 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 Applicable |
| 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
|
This is a double-arm interventional trial that will examine the effectiveness of individualised homoeopathic medicine in comparison to placebo as an intervention to treat Non-Alcoholic Fatty Liver Disease (NAFLD) in adults. The sample size that will be used will comprise 54 participants who meet the inclusion criteria that will be divided into two groups (Group A) which will receive individualized homoeopathic medicine with concomitant care (yoga and proper diet ) and Group B which will receive placebo with the same concomitant care. The research process will take one year and six months and monthly follow-ups of each patients or as per requirements, upto six months. The main outcomes involve the evaluation of hepatic changes of fatty in the liver through Fib-4 score and serum ALT; secondary outcome is the ultrasonographic assessment of the status of hepatomegaly after six months. The research aims to establish whether individualised homoeopathic treatment can provide any substantial result as compared to the placebo in the management of NAFLD as a part of the evidence-based validation of homoeopathic treatment.
|