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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 liverPharmacological 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. 

 
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