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CTRI Number  CTRI/2022/02/040009 [Registered on: 03/02/2022] Trial Registered Prospectively
Last Modified On: 03/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Liver protective drug action of homoeopathic preparation of Myrica cerifera 3C on Non alcoholic fatty liver disease 
Scientific Title of Study   Preclinical studies on Molecular understanding of Hepatoprotective drug action of homoeopathic preparation of Myrica cerifera 3C and its clinical effectiveness in comparison to Individualised homoeopathic medicine in patients suffering from the Non Alcoholic Fatty Liver Disease with respect to Liver Function Test parameters: An open label Randomised Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raja Manoharan 
Designation  Associate Professor 
Affiliation  National institute of Homoeopathy 
Address  Department of Homoeopathic Pharmacy Block GE Sector III Salt Lake Kolkata 106
Block GE Sector III Salt Lake Kolkata 106
North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  9163955737  
Fax    
Email  drrajanih@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samir kumar pal 
Designation  Professor 
Affiliation  S N Bose National Centre for Basic Sciences (SNBNCBS) 
Address  Department of Chemical, Biological and Macromolecular Science S N Bose National Centre for Basic Sciences (SNBNCBS) JD Block Sector-III Salt Lake Kolkata
Department of Chemical, Biological and Macromolecular Science S N Bose National Centre for Basic Sciences (SNBNCBS) JD Block Sector-III Salt Lake Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  9331295025  
Fax    
Email  skpal.snbncbs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRaja Manoharan 
Designation  Associate Professor 
Affiliation  National institute of Homoeopathy 
Address  Department of Homoeopathic Pharmacy Block-GE Sector 3 Salt lake Kolkata 106
Department of Homoeopathic Pharmacy Block-GE Sector 3 Salt lake Kolkata 106
North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  9163955737  
Fax    
Email  drrajanih@gmail.com  
 
Source of Monetary or Material Support  
Self Financing 
 
Primary Sponsor  
Name  Dr Raja Manoharan 
Address  Department of Homoeopathic Pharmacy Block GE Sector III Salt lake Kolkata 
Type of Sponsor  Other [Self financing] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raja Manoharan  OPD and IPD of National Institute of Homoeopathy  Block GE Sector III Salt lake Kolkata 106
North Twentyfour Parganas
WEST BENGAL 
9163955737

drrajanih@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  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  Myrica cerifera 3C and individualised Homoeopathic medicine  Two-four globules of Myrica cerifera 3C once in a day for two months and one dose in alternative days for next two months. Individualised homoeopthic medicine will be selected as per the totality of symptom and administered in centesimal potency. 
Comparator Agent  Myrica cerifera 3C in one arm and Individualised Homoeopathic medicine in another arm  Each dose is consisting of Two–Four globules in globules no: 20, medicated with Myrica cerifera 3C, and prescribed OD per day for Two-month, AD for next two months in Myrica cerifera 3C arm. The individualized Homoeopathic Medicine are prescribed in centesimal potencies as detailed above and in individualized dosage, as decided appropriate to the case or condition. On each occasion, single individualized Homoeopathic Medicine is prescribe considering symptom totality, clinical history details, constitutional traits, miasmatic features and repertorization as and when required. Subsequent prescription is produced in accord with Kent’s observations and Herring’s Law of cure.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Conformed Diagnosis of NAFLD established by ultrasound.
There is no significant alcohol consumption
There are no competing aetiologies for hepatic steatosis
There are no co existing causes for chronic liver disease
Alanine transaminase (ALT) more than 40 UL as considered elevated.
Providing written informed consent to participate.
 
 
ExclusionCriteria 
Details  Absence of regular or excessive use of alcohol (more than 20 gram per day in men and 10 gram in female).
History of bowel surgery, Bariatric surgery or undergoing evaluation for bariatric surgery
for obesity, extensive small bowel resection or orthotopic liver transplants.
History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, Cholestatic and metabolic liver diseases) and hemochromatosis.
Known case of cirrhosis
Patients with Hypothyroidism
History of myopathies or evidence of active muscle disease.
History of bladder disease and /or haematuria or has haematuria except due to UTI.
Pregnant women, Lactating women & paediatric age group (< 18yrs)
Uncontrolled Diabetes, Hypertension, Mental illness or depression, kidney or heart disease, Malignant conditions as well as with history of stroke.
Person under corticosteroid therapy.
Patients who are too sick for consultation and not willing to cooperate
Unwilling to take part and not giving consent to join the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 

Total bilirubin ALT AST Prothrombin time Albumin Globulin ratio 
All the parameters will be assessed at baseline after 2 months and after 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
USG (Whole abdomen) alkaline phosphatase.  alkaline phosphatase will be assessed baseline after 2 months and after 4 months and USG (Whole abdomen) will be assessed baseline and after 4 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   03/02/2022 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Nonalcoholic fatty liver disease (NAFLD) is considered the most common cause of chronic liver disease in both the developed as well as developing countries as per studies from different regions of India in the current scenario. NAFLD is a spectrum ranging from nonalcoholic fatty liver (NAFL) to nonalcoholic steatohepatitis (NASH), which may progress to liver cirrhosis and hepatocellular carcinoma. NAFLD is now recognized as a multisystem disease and has been associated not only with increased liver-related morbidity and mortality but also with increased morbidity and mortality related to cardiovascular disease, chronic kidney disease, osteoporosis, and extrahepatic malignancy. Whereas NAFL has a negligible risk of progression, 10-30% of NASH patients may develop cirrhosis or HCC. Ludwig et al., coined the term NASH for alcohol-like liver disease that developed in persons who were not heavy drinkers (< 20 g/day for men and < 10 g/day for women) .

NAFLD is now recognized as one of the major chronic liver diseases in industrialized countries. At present, NAFLD is an increasing major health problem worldwide. At the time of diagnosis, most patients with NAFLD have minimal signs and symptoms of liver disease, even though some patients have discomfort or sensation of fullness on the right side of the upper abdomen, there is generalized fatigue with hepatomegaly in most of the patients. The prevalence of NAFLD is 15-40% in western countries and 9-40% in Asia. Epidemiological studies suggest the prevalence of NAFLD is 9-32% in the general Indian population and with maximum prevalence in those between 40 and 50 years of age. The highest prevalence of 32% was reported from the urban part of southern India.

One large study showed no difference in liver-related adverse events between definite NASH and severe steatosis. However, patients with advanced fibrosis at presentation were much more likely to progress than those without, and these patients, therefore, require to follow-up. In the cohort, complications of cirrhosis were the third most common cause of death, following cardiovascular events and non-hepatic malignancies.

The lifestyle advice and modifications are the first line of advice to manage the patients with NAFLD and NASH. Life advice is aimed at weight loss, increasing physical activity and attention to the cardiovascular risk factor. A reduction of more than 7-9% in body weight has been associated with reduced steatosis, hepatocellular injury and hepatic inflammation.

Although numerous pharmaceutical agents have been tried, they all lead to unacceptable side effects and limited efficacy during long-term therapy. Homeopathic medicine like Myrica cerifera has marked action on the liver and is used to treat Jaundice with scanty, yellow frothy urine. A study showed that metformin (1g/day) and pioglitazone (30 mg /day) were safe and equally affected LFT, HoMA-IR, lipid profile, and LFC in NAFLD patients in four months. Another study showed that there was a significant improvement in hepatic steatosis as assessed by the controlled attenuation parameters (CAP) after short-term vitamin D correction in NAFLD patients (20).

The previous studies reported the apoptosis activity with individual chemical compounds namely myricanone from Myrica cerifera in different cancer cell lines including hepatic cancer cell lines. However, no attempt was made to confirm the drug action of Homoeopathic preparation (Dilution) of Myrica cerifera 3C on NAFLD. In this proposed study the comparative effectiveness of Myrica cerifera 3C with Individualised homeopathic medicines may give the scientific background for the effectiveness of Homoeopathic preparation of Myrica cerifera 3C in NAFLD.

Therefore, it is necessary and of considerable interest to prove the efficacy of the Homoeopathic Preparation of Myrica cerifera 3C for the treatment of NAFLD. In this context, an effective Homoeopathic preparation of Myrica cerifera 3C without side effects could be used to reduce the oxidative stress that can subsequently lead to the healing of liver insults.

 
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