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
|
|
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
|
|
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.
|
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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
|
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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. |