Liver protective drug action of homoeopathic preparation of Myrica cerifera 3C on Non alcoholic fatty liver disease

Not yet recruiting

Conditions: Fatty (change of) liver, not elsewhere classified,

Registration Number: CTRI/2022/02/040009

Lead Sponsor: Dr Raja Manoharan

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* 3Cfor 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): OPD and IPD of National Institute of Homoeopathy
🇮🇳
Parganas, WEST BENGAL, India
OPD and IPD of National Institute of Homoeopathy
🇮🇳Parganas, WEST BENGAL, India
Dr Raja Manoharan
Principal investigator
9163955737
drrajanih@gmail.com