Status of digestion in non alcoholic fatty liver disease and the therapeutic effect of chitrakapippali ghrita.

Phase 2/3

Completed

• Conditions: Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,

• Registration Number: CTRI/2023/04/051431
• Lead Sponsor: ALL INDIA INSTITUTE OF AYURVEDA

Brief Summary

INTRODUCTION

Ayurveda has described agni as an important factor of digestion and metabolism in our body. It acts as an invariable agent in the process of paka and includes the complete process of ingestion and transformation. In our classical Ayurvedic texts agni varies and is classified according to the pakriti, dosha, dhatu, and the function.



RESEARCH QUESTION

- What is the role of status of agni in yakrita vikara (NAFLD)?

- What is the clinical efficacy of chitrakapippali ghrita in yakrita vikara (NAFLD) patients?



HYPOTHESIS:

Null Hypothesis:

- The agni does not have any significant role in the pathogenesis of yakrita vikara

(NAFLD).

- The administration of chitrakapippali ghrita does not have any beneficial clinical effect in yakrita vikara (NAFLD) patients.

Alternate Hypothesis:

- The agni plays a significant role in the pathogenesis of yakrita vikara (NAFLD).

- The administration of chitrakapippali ghrita has significant beneficial clinical effect in yakrita vikara (NAFLD) patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-14
• Study Completion: 2024-09-15
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

GRADE I and II NAFLD.

Exclusion Criteria

• Patients suffering from diabetic Mellitus, dyslipidemia, hypothyroidism, IBS, joint disorders, CAD, TB, and carcinoma Patients having Grade III NAFLD and any other liver disease Patients on medication for non-alcoholic fatty liver disease during last 3 months.
• Lactating and pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Status of agni as assessed through CCRAS agni assessment questionnaire.	Status of agni will be assessed at 1st,15th,30th,46th day of intervention.

Secondary Outcome Measures

Name	Time	Method
Changes in USG finding.	Changes in USG findings will be assessed at 1st and 46th day.

Trial Locations

Locations (1)

O.P.D room no. 1 and IPD of All India Institute of Ayurveda; 🇮🇳 South, DELHI, India

O.P.D room no. 1 and IPD of All India Institute of Ayurveda

🇮🇳South, DELHI, India

Rashmi Meena

Principal investigator

9560138479

rashmisweet835@gmail.com