A Randomized controlled trial of Kalmegh onNon Alcoholic Fatty Liver Disease.

Phase 3

Not yet recruiting

• Conditions: Localized adiposity. Ayurveda Condition: Yaká¹›t Roga (liver disease) and Medoroga (obesity).,

• Registration Number: CTRI/2021/10/037692
• Lead Sponsor: Department of community medicine INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY

Brief Summary

**Non-alcoholic fatty liver disease (NAFLD) is a multifactorial disease and the most common of chronic liver diseases worldwide. NAFLD is present in ~32% of general population in India and its prevalence is rising remarkably, in parallel to that of obesity, especially in developing countries such as India. The global prevalence of NAFLD is estimated to be 25%, with the lowest prevalence in Africa (13.5%) and highest in the Middle East (31.8%) and South America (30.4%). Non-alcoholic fatty liver disease (NAFLD), is recognized as a health care burden worldwide. The rapidly rising healthcare and economic burdens of NAFLD warrant institution of preventative and treatment measures in the high-risk sub-populations in an effort to reduce the morbidity and mortality associated with NAFLD. For the purpose of present clinical study Kalmegh is selected as a trial drug for comprehensive clinical trial in NAFLD. There will be two groups of study subjects for the trial, control group and experimental group. Control group will receive the standard treatment i.e. dietary advice and exercise. Experimental group will receive the drug intervention apart from advice on diet and exercise. Drug Intervention is Kalmegh (Andrographis Paniculata Nees)  1/2  to 1ml, twice a day before meal in the form of Ghanvati for 6 months.  Study participants and data analyzer will be blinded regarding the allocation of the group.  Total 3 follow ups will be done, first after 1 month of treatment, second after 3 months of treatment, third after 6 month of treatment to see the changes in the parameters of investigation reports. Outcome assessment for effectiveness of kalmegh will be done on the basis of prepared proforma and improvement in patients with NAFLD on the basis of fibro scan and USG liver reports of the NAFLD patients after 6 months of treatment.**

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-10-28
• Study Start: 2021-11-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• 1.Patient giving consent to participate in the study.
• 2..Adult Population of age group 18-60yrs attending Gastroenterology OPD 3.Patient with simple fatty liver Patient with Non-Alcoholic SteatoHepatitis.
• 4.Patient with Non-Alcoholic SteatoHepatitis and fibrosis of STAGE -I and STAGE-II.

Exclusion Criteria

• 1.Patient having Diabetes Mellitus.
• 3.Patient with NASH and fibrosis of STAGE-3.
• 4.Patient with liver cirrhosis.
• 5.Patient with severe obesity.
• 6.Patient not giving consent to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome assessment for effectiveness of kalmegh will be done on the basis of prepared proforma and improvement in patients with NAFLD on the basis of fibro scan and USG liver reports of the NAFLD patients after 6 months of treatment. Also to assess the agreement of noninvasive methods, like LFT and liver USG with Fibro scan liver.	Total 3 follow ups will be done, first after 1 month of treatment, second after 3 months of treatment, third after 6 month of treatment to see the changes in the parameters of investigation reports.

Secondary Outcome Measures

Name	Time	Method
To evaluate the cost of one-month treatment of Kalmegh for treatment NAFLD.	Total 3 follow ups will be done, first after 1 month of treatment, second after 3 months of treatment, third after 6 month of treatment to see the changes in the parameters of investigation reports.

Trial Locations

Locations (1)

Sir Sunderlal Hospital, Institute Of Medical sciences BHU; 🇮🇳 Varanasi, UTTAR PRADESH, India

Sir Sunderlal Hospital, Institute Of Medical sciences BHU

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Sanket Vilas Nandekar

Principal investigator

7588779807

sanket31081994@gmail.com