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A clinical study to evaluate the effect of two herbal drugs, bhunimba kshara and katuki churna in combination with restricted diet, exercise and yoga in patients of Non- alcoholic fatty liver disease.

A double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba Kshara and Katuki Churna along with lifestyle modifications in the management of Non-Alcoholic Fatty Liver disease(NAFLD)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018039
Enrollment
30
Registered
2019-03-12
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: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Bhunimba Kshara capsule 125 mg, BD Katuki Churna capsule, 1g,HS: Bhunimba Kshara Capsule,125mg two tablets twice daily Orally for 30 days Katuki churna capsule,1g, bedtime, orally, for

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Non-alcoholic fatty liver disease patient who diagnosed by abdomen ultrasonic examination and Non-drinker Or total abstainer or with alcohol intake of less than 20g per day for female and less than 30 g per day for males NAFLD confirmed by USG with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen 3. Voluntary agreement and enrolment.

Exclusion criteria

Exclusion criteria: The ratio of AST and ALT over 2 Metabolic syndromes such as Type I and II diabetes mellitus hypertension Thyroid dysfunctions hypothyroidism or hyperthyroidism Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months Patient taking any product which affects the BMI or hyperlipidemia

Design outcomes

Primary

MeasureTime frame
Changes in the infiltration of fat globules in Ultrasonography (USG) findings along with changes in clinical presentationsTimepoint: Zero Thirteith day

Secondary

MeasureTime frame
Liver function tests Lipid profile Changes in body weight, BMI and waist hip ratio Relief of the following symptoms like Fatigue, Pain in epigastrium, Anorexia, Nausea Overall improvement in quality of lifeTimepoint: Zero Thirty

Countries

India

Contacts

Public ContactDr Mangalagowri V Rao

All India Institute of Ayurveda

drvghuddar@gmail.com9986697942

Outcome results

None listed

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