A Clinical trial to compare the effect of diet and life style modification with and without Kalyanaka Kshara in managing Non Alcoholic Fatty Liver Disease.

A clinical study on the effect of Kalyanaka Kshara as an add on treatment with Diet and Lifestyle modification in comparison to Diet and Lifestyle modification alone in Non-Alcoholic Fatty Liver Disease A Randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084612

Enrollment

Registered

2025-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Between age group of 25-60years irrespective of gender Patients having Grade I Non-alcoholic fatty liver disease diagnosed by Ultrasound abdomen. BMI greater than 25kg/m2 Normal LFT

Exclusion criteria

Exclusion criteria: Pregnant and lactating ladies Known case of malignancy, uncontrolled diabetes and uncontrolled hypertension Significant alcohol consumption less than 20g per day Autoimmune liver disease Diagnosed cases of renal, respiratory, cardiovascular, neurologic or hematological diseases

Design outcomes

Primary

Measure	Time frame
Reduction of the Liver Stiffness (Fibrosis assessment-kPa) and Liver Steatosis (CAP) in Grade I Non-Alcoholic fatty liver Disease using FibroscanTimepoint: Screening on visit 1(0th day), Assessment on visit 2(1st day) and visit 4( 32nd day), routine checkup and medicine replenishment in between on Visit 3( 16th day)	—

Secondary

Measure	Time frame
Reduction in BMITimepoint: Screening on visit 1(0th day), Assessment on visit 2(1st day) and visit 4( 32nd day), routine checkup and medicine replenishment in between on Visit 3( 16th day)	—

Countries

India

Contacts

Public ContactDr Shyam Vinayan

Amrita School Of Ayurveda

drshyamvinayan@gmail.com9447712392

Outcome results