| CTRI Number |
CTRI/2024/03/064635 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of fatty liver |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in reducing serum alanine transaminase level in adults with non-alcoholic fatty liver disease: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-1106 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajarshi Mallick Choudhury |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, OPD PG1 and Medicine (room no. 1), 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
7980300351 |
| Fax |
|
| Email |
rajmc11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Principal-in-Charge, Administrator, and Head |
| Affiliation |
D.N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, OPD PG1 and Medicine (room no. 1), 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Principal-in-Charge, Administrator, and Head |
| Affiliation |
D.N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine, OPD PG1 and Medicine (room no. 1), 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D.N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra Kolkata- 700046 |
| 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 Rajarshi Mallick Choudhury |
D. N. De Homoeopathic Medical College and Hospital |
Dept of Organon of Medicine PG1 OPD, Medicine OPD(room no 1), Research OPD
12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL |
7980300351
rajmc11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De 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 |
| Comparator Agent |
Identical-looking placebos and concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients of both groups will receive concomitant care in the form of general management which will include diet consisting of vegetables, fruits, whole grains, beans and legumes, low-fat or fat-free dairy products, fish, poultry, non-tropical vegetable oils and nuts and limiting added sugars, sugary beverages, sodium, highly processed foods, refined carbohydrates, saturated fats, and fatty or processed meats, low-carbohydrate and high-fibre diet, yoga therapy, avoidance of ultra-processed and packaged food products. Duration of therapy: 3 months |
| Intervention |
Individualized Homoeopathic Medicines and concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and the sundry items will be procured. All the enrolled patients of both groups will receive concomitant care in the form of general management which will include diet consisting of vegetables, fruits, whole grains, beans and legumes, low-fat or fat-free dairy products, fish, poultry, non-tropical vegetable oils and nuts and limiting added sugars, sugary beverages, sodium, highly processed foods, refined carbohydrates, saturated fats, and fatty or processed meats, low-carbohydrate and high-fibre diet, yoga therapy, avoidance of ultra-processed and packaged food products. Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals with Grade I and Grade II Fatty liver established by Ultrasonography and ALT enzyme levels greater than upper limit of normal. (upper limit of normal ALT is considered to be more than 30 IU/mL in males and more than 19 IU/mL in females ).
2.Age 18 to 65 years.
3.Participants of either sex or transgender.
4.Participants having prior experience or knowledge of the treatment; example - primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet |
|
| ExclusionCriteria |
| Details |
1.Not providing with written informed consent of voluntary participation.
2.Regular or excessive use of alcohol, tobacco, substance abuse and any other addiction.
3.Individuals with NAFLD Fibrosis Score more than 0.675.
4.History of Viral hepatitis B or C, autoimmune hepatitis.
5.Cholestatic and metabolic liver diseases, hemochromatosis and liver transplants.
6.Combined with uncontrolled diabetes (participants under modern medications having poor glycemic control denoted by HbA1c more than 6.5%), uncontrolled hypertension (SBP more than 140 and DBP more than 90 mm of Hg with modern medications), renal or cardiac disease, stroke or any other severe systemic diseases affecting quality of life.
7.Person under corticosteroid therapy.
8.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill, mentally incompetent people.
9.Pregnant and puerperal women and lactating mother.
10.Self-reported immune-compromised state.
11.Already undergoing homoeopathic treatment within last 3 months for any other disease.
12.Simultaneous participation in any other trials. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum ALT level |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chronic liver disease questionnaire (CLDQ) |
Baseline, every month, up to 3 months |
| Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) |
Baseline, every month, up to 3 months |
| Liver function test (Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, Total Protein, Albumin, Globulin, AST, ALP). |
At baseline and after 3 months |
| Blood lipid profile (Triglycerides, Total cholesterol, Very-Low-Density Lipoprotein cholesterol, High-density Lipoprotein cholesterol, Low-Density Lipoprotein cholesterol) |
At baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajmc11@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
NAFLD is the leading cause of chronic liver disease worldwide with an estimated prevalence of 32%. Although it is asymptomatic to begin with but it may progress to a steatohepatitis, cirrhosis and even primary liver cancer. As of now there is no established standard treatment of this clinical condition. Homoeopathy has immense potential to offer treatment for reduction of liver fat and serum liver enzymes but has remained seriously under-investigated till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of NAFLD in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 72 adults who are suffering from NAFLD at the OPD of D. N. De Homoeopathic Medical College and Hospital. Primary outcome assessment will be done by evaluating the serum ALT levels after 3 months of intervention. Chronic liver disease questionnaire(CLDQ) [secondary outcome], Measure Yourself Medical Outcome Profile version2.0 (MYMOP-2) [secondary outcome] every month up to 3 months. Lipid profile[secondary outcome] and Liver function Test[secondary outcome] will be assessed at baseline and after 3 months of intervention. Group differences will be analyzed statistically. Results will be published in a scientific journal. |