| CTRI Number |
CTRI/2025/02/080994 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Homoeopathic Medicines in the treatment of non alcoholic fatty liver disease. |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in comparison with Chionanthus Virginica 6C in the treatment of non alcoholic fatty liver disease an open label randomized clinical trial. |
| 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 Souvik Poali |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy block GE sector 3 salt lake kolkata , Department of homoeopathic materia medica Outpatient department room no.18
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7384334915 |
| Fax |
|
| Email |
souvikpoali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Souvik Poali |
| Designation |
post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy block GE sector 3 salt lake kolkata , Department of homoeopathic materia medica Outpatient department room no.18
WEST BENGAL
700106
India |
| Phone |
7384334915 |
| Fax |
|
| Email |
souvikpoali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Ghelani Uchat |
| Designation |
Professor and HOD of Homoeopathic Materia medica |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy block GE sector 3 salt lake kolkata , Department of homoeopathic materia medica Outpatient department room no.18
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830966265 |
| Fax |
|
| Email |
ushauchat@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
self Dr. Souvik Poali |
| Address |
National Institute of Homoeopathy block GE sector 3 salt lake kolkata , Department of homoeopathic materia medica Outpatient department room no.18
|
| Type of Sponsor |
Other [self] |
|
|
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 Souvik Poali |
National Institute of Homoeopathy |
National Institute of Homoeopathy block GE sector 3 salt lake kolkata , Department of homoeopathic materia medica Outpatient department room no.18
North Twentyfour Parganas
WEST BENGAL |
7384334915
souvikpoali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
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 |
| Comparator Agent |
Chionanthus Virginica 6C |
Chionanthus Virginica 6C in case of non alcoholic fatty liver disease evaluated by Liver function test and Ultrasonography of abdomen |
| Intervention |
Individualized Homoeopathic medicine in case of non alcoholic fatty liver disease |
Individualized Homoeopathic medicine in case of non alcoholic fatty liver disease evaluated by Liver function test and Ultrasonography of abdomen |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of fatty liver of any grade as visible in USG
Patient with elevated liver enzyme ALT more than 40 international unit per liter in Blood
Both male and female patients aged between 20 to 70 years irrespective of all religions, and of different socioeconomic status who are willing to give written consent for participating in study and complete follow-up during study
NAFLD confirmed by USG with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen who are willing to give written consent for participating in the study and complete follow up during study
|
|
| ExclusionCriteria |
| Details |
Pregnant females and lactating mothers.
Individuals not providing written informed consent for the study.
Patient with evidence of liver disease other than NAFLD like alcoholic fatty liver, viral hepatitis, autoimmune liver diseases, hepatocellular carcinoma, Gilbert syndrome, Crigler Najjar syndrome, Wilson disease, Hemochromatosis etc.
Patient with uncontrolled diabetes, uncontrolled hypertension, renal or cardiac disease, stroke or any other serious systemic and terminal illness.
Patient who are taking any allopathic medicine or supplementary medicine for NAFLD.
There is history of significant alcohol consumption.
|
|
|
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 |
| Changes in LFT parameters ALT, AST, ALP, GGT, Bilirubin, Albumin, Globulin will be assessed. |
Changes in LFT parameters ALT, AST, ALP, GGT, Bilirubin, Albumin, Globulin will be assessed at baseline, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in USG will be assessed.
Changes in BARD SCORE will be assessed.
|
baseline and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
24/02/2025 |
| 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)
Modification(s)
|
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
|
Non-alcoholic fatty liver disease (NAFLD) is a
condition in which excessive fat accumulation builds in the form of triglycerides
in the hepatocytes of liver who do not consume alcohol. The liver normally contains
some fat, an individual is considered to have a fatty liver (hepatic steatosis)
if the liver contains more than 5 to 10 percent fat. NAFLD has become one of the most common liver diseases worldwide,
affecting approximately 25% of the global population. This is an open label, two arm, randomized clinical trial, total sample size is 62, 31 patients will be given Individualized homoeopathic medicine and other 31 patients will be given Chionanthus Virginica - 6C by using the random number chart. Aim of this study is to determine the the effectiveness of Individualized homoeopathic
medicine in comparison with Chionanthus Virginica - 6C
in the treatment of NAFLD. Primary objective of this study is to compare changes in Liver function test parameters and Secondary objective is to compare the changes in Ultrasonography findings and BARD SCORE. Primary outcome will be assessed by changes in Liver function test parameters at baseline, 3 months and 6 months. Secondary outcome will be assessed by changes is USG and BARD SCORE at baseline and 6 months. Total study duration is 18 months. This open label randomized clinical trial will be an attempt to explore the effects of Homoeopathy in the treatment of NAFLD. |