| CTRI Number |
CTRI/2025/06/089561 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in fatty liver disease |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic treatment add on to lifestyle modifications in cases of Non-Alcoholic Fatty Liver Disease (NAFLD): A double-blind randomized placebo-controlled trial |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| U1111-1324-7619 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baidurjya Bhattacharjee |
| Designation |
Research Officer (Homoeopathy) Scientist- 1 |
| Affiliation |
Regional Research Institute for Homoeopathy, Siliguri |
| Address |
Regional Research Institute for Homoeopathy Siliguri
Room no. 107
Dept of Clinical Research
Chhotapathuramjote
Opposite The Art of Living Ashram
Darjiling WEST BENGAL 734012 India |
| Phone |
9239297736 |
| Fax |
|
| Email |
baibhms@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Baidurjya Bhattacharjee |
| Designation |
Research Officer (Homoeopathy) Scientist- 1 |
| Affiliation |
Regional Research Institute for Homoeopathy, Siliguri |
| Address |
Regional Research Institute for Homoeopathy Siliguri
Room no. 107
Dept of Clinical Research
Chhotapathuramjote
Opposite The Art of Living Ashram
Darjiling WEST BENGAL 734012 India |
| Phone |
9239297736 |
| Fax |
|
| Email |
baibhms@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Research Officer (Homoeopathy) Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
Room no 317
Department of Clinical Research
61-65 Institutional Area Opp D Block
Janakpuri
South West DELHI 110058 India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Ministry of Ayush Govt of India
61-65 Industrial Area, Opp D Block, Janakpuri, New Delhi, India, Pin 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional Area Opposite D Block Janakpuri
New Delhi 110058, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lipi Pushpa Debata |
Central Research Institute for Homoeopathy Lucknow |
Room no. 219, OPD 1
Department of Clinical Research
HC/NH, Sector 2, Jankipuram extension, Lucknow, Uttarpradesh, Pin 226301 Lucknow UTTAR PRADESH |
7755014040
drlipi08@gmail.com |
| Dr Partha Pratim Pal |
Dr Anjali Chatterjee Regional Research Institute for Homoeopathy Kolkata |
Room No 315, OPD 2
Department of Clinical Research
50, Rajendra Chatterjee Road
Kolkata 700035 North Twentyfour Parganas WEST BENGAL |
8910890779
justdoit.partha@gmail.com |
| Dr Amulya Ratna Sahoo |
Regional Research Institute for Homoeopathy Guwahati |
Room No. 102, OPD 111
Ground floor, Old CARI building (Ayurvedic campus)
Borsojai, P.O. Beltola, Guwahati 781028 Kamrup ASSAM |
8763721546
drarsahoo@gmail.com |
| Dr Baidurjya Bhattacharjee |
Regional Research Institute for Homoeopathy Siliguri |
Room no 107, OPD 2
Dept of Clinical Research
Chhotapathuramjote
Opp The Art of Living Ashram Darjiling WEST BENGAL |
9239297736
baibhms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Central research institute for homoeopathy Lucknow |
Approved |
| Institutional Ethics Committee of Dr Anjali Chatterjee Regional Research Institute for Homoeopathy Kolkata |
Approved |
| Institutional Ethics Committee of Regional Research Institute for Homoeopathy Guwahati |
Approved |
| Institutional Ethics Committee of Regional Research Institute for Homoeopathy Siliguri |
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 |
Homoeopathic Treatment |
Homoeopathic dilutions selected on the basis of the individualizing symptoms of the participant shall be administered in oral form. The dilutions shall be dispensed by moistening the dilution in 30 no. cane sugar globules in glass vials, of which 4-5 such globules shall consist of a single dose. The dosage of the medicine and the frequency of medicine repetition required shall be determined on the investigators discretion.
Homoeopathic mother tinctures shall be administered to the study participant orally as per the indications observed by the investigator. The medicine shall be provided to the participant in glass or plastic bottles, and 10 to 20 drops of the intervention shall be administered in 30 ml of drinking water as per the requirement in the participant. The repetition of the medicine is as per the discretion of the investigator.
Dietary and lifestyle modifications shall be provided as per the existing guidelines in addition to oral medicines.
Duration of intervention: 12 months |
| Comparator Agent |
Similar looking placebo |
Placebo looking similar to homoeopathic dilutions shall be administered by using 90% v/v Ethanol moistening them in in 30 no cane sugar globules. 4 to 5 globules of such shall comprise of a single dose and shall be administered by oral route. The dosage and repetition shall be per the discretion of the investigator.
Placebo looking similar to homoeopathic mother tinctures shall be prepared by dissolving caramel in 90% v/v ethanol to replicate the product. The mixture shall be administered by oral route of which 10 to 20 drops shall comprise of a single dose. The exact dosage and repetition of the product shall be as per the discretion of the investigator.
Dietary and lifestyle modifications shall be provided as per the existing guidelines in addition to oral medicines.
Duration of intervention/control: 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients visiting the OPD of study centers with ultrasonography evidence of fatty changes in the liver on incidental discovery.
2. Fatty liver changes demonstrated by ultrasonography in patients with incidental increase in liver transaminases (ALT and AST)
3. Fatty liver changes demonstrated by ultrasonography in persons screened with either of increased waist circumference (more than 90cm in males and more than 80cm in females), impaired fasting glucose (Fasting glucose more than equal to 110 mg/dl or on pharmacological treatment for impaired glucose), increased blood pressure (more than equal to 130/85 mm of Hg or on antihypertensives), hypertriglyceridemia (Serum triglycerides more than equal to 150mg/dl or on triglyceride or lipid lowering drugs), decreased HDL levels (less than 40 mg/dl in males and less than 50 mg/dl in females).
4. Patients presenting with Grade 1 (mild) or Grade 2 (Moderate) fatty liver on ultrasound examination
5. Patients with transient elastography (FibroScan) Liver Stiffness Measurement scores of less than 9.3kPa (by M probe) and less than 9.6kPa (by XL probe)
6. Patients with FIB 4 score less than equal to 1.45
7. Age 18 to 75 years of age
8. All sexes
9. Patients on oral hypoglycemic drugs, antihypertensives, lipid lowering drugs, and LT4 drugs with controlled disease conditions for which such drugs are administered.
10. Patients with ability to perform and comply to exercise and lifestyle modifications
11. Willing to give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from self-reported cases of liver cirrhosis, hepatocellular carcinoma, hereditary hemochromatosis, Wilson’s disease, alpha 1 antitrypsin deficiency or any other malignancy or any end-stage disease.
2. Patient with positive HbsAg and/or anti HCV antibody.
3. Patients with associated acute or chronic cholecystitis (calculous or acalculous). Patients with such conditions may be included after 6 months of cholecystectomy
4. Drug-induced liver disease
5. Patient with a history of regular alcohol intake demonstrated by CAGE scores of more than equal to 3
6. Patients who are immune-compromised or have steroid medication.
7. Pregnant and lactating mothers
8. Persons with severe Musculoskeletal disorders and unable to perform the prescribed physical activities and exercise.
9. Persons with severe mental illness like mania, insanity.
10. Persons not willing to provide consent for the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Qualitative assessment of the liver by ultrasonography:
|
The scoring shall be done at baseline, 6 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quantitative assay of Alanine Aminotransferase (ALT)
|
The assay shall be performed at baseline, 6 months and 12 months |
Liver Stiffness measure score using transient elastography (Fibroscan)
|
The scoring shall be done at baseline, and end of 12 months follow-up |
Liver fibrosis by Fib 4 scores
|
The assessment shall be performed at baseline, 6 months and 12 months |
Quantitative assay of serum triglyceride and high-density lipoprotein cholesterol level
|
At baseline and at the end of study at 12 months |
Assessment of causality of adverse events using Naranjo ADR probability scale
|
At any period during the study whenever any adverse reaction is noted |
| CAP score by fibroscan |
The assessment shall be performed at baseline, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
01/08/2025 |
| 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="3" Months="0" 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
|
Non-alcoholic fatty liver disease is a clinic-histopathological condition characterized by a spectrum of conditions characterized histologically by macrovesicular hepatic steatosis in those who do not consume alcohol in amounts generally considered harmful to the liver. The global prevalence of the disease is approximately 25% of the population and the prevalence of disease in India is approximately 9 – 35%. Obesity, type 2 (non-insulin-dependent) diabetes mellitus, and hyperlipidaemia are coexisting conditions frequently associated with NAFLD. The condition can be found in any age group including in childhood but the highest prevalence has been observed between 40 – 50 years of age. Most of the cases of NAFLD do not produce any signs of liver disease at the time of diagnosis, although symptoms of fatigue or malaise and sensation of discomfort or fulness over the right upper part of the abdomen may be present. An incidental rise in transaminases and fatty liver during ultrasonography conducted during routine check-ups may be the only demonstrable sign of the disease. Ultrasonography has a specificity and sensitivity of 85% in the detection of hepatic steatosis. Biochemical tests usually show mildly elevated AST and ALT, with the latter often higher. Fibroscan (transient elastography) is another non-invasive procedure that determines the extension of fibrosis within the liver tissue and directly does not relate to the fat content within the liver. Pharmacological interventions for the condition did not offer much conclusive evidence till now as most of the reviews and clinical practice guidelines suggested. The availability of the evidence suggests a very low quality of evidence with a high risk of bias. Certain herbal medicines also demonstrated some positive evidence but again such studies suffered a significantly high risk of bias. No studies have been conducted in Homoeopathy on this condition to date. Moreover, Homoeopathy has also been criticized to be a causative factor behind the development of severe hepatitis due to the vehicle of alcohol being used in Homoeopathic medicines. Therefore a double blind placebo controlled study as an add on to lifestyle modification is being conducted to generate the necessary evidence for the condition. The study shall include patients aged 18 to 75 years of all gender with evidences of fatty changes in liver and shall be prospectively studied to observe changes in the laboratory and imaging parameters to elicit changes in relation to intervention and placebo along with lifestyle modifications. The study is of 3 years duration, after which the the data shall be subjected to statistical analysis and the findings shall be disseminated to the scientific community for further researches and implementations. |