A Randomized controlled trial of Kalmegh on Non Alcoholic Fatty Liver Disease.

A Randomized Controlled Trial of Kalmegh on Non Alcoholic Fatty Liver Disease.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037692

Enrollment

112

Registered

2021-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E65- Localized adiposity

Interventions

Intervention1: KALMEGH -Ayurvedic preparation : 1/2 to 1ml, twice a day before meal in the form of Ghanvati for 6 months. Control Intervention1: PLACEBO: Will look like intervention but without any

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Patient having Diabetes Mellitus. 2.Patient with alcoholic addiction. 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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

Measure	Time frame
To evaluate the cost of one-month treatment of Kalmegh for treatment NAFLD.Timepoint: 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.	—

Countries

India

Contacts

Public ContactDr Sanket Vilas Nandekar

Department of community medicine IMS BHU Varanasi

sunilk.cmed@bhu.ac.in9450808948

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026