A Clinical trial to study the effect of Kokilaksha Kshara in patients with Gall Bladder Stones.

Phase 2

Completed

• Conditions: Calculus of gallbladder without cholecystitis. Ayurveda Condition: PITTAJA-ASMARI,

• Registration Number: CTRI/2023/03/050203
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

This is a Single Arm Clinical Trial studying the Efficacy of  Kokilaksha Kshara in patients with Cholelithiasis, that will be conducted in All India Institute of Ayurveda, New Delhi, India. The Primary outcome measures will be reduction in size of gall bladder stones, reduction in no. of gall bladder stones, and improvement in gall bladder status with use of  Kokilaksha Kshara for 45 days . The secondary outcomes will be improvement in patients Symptoms relating to cholelithiasis (observations based on different scales) at a period of 45 days.

Null hypothesis was accepted

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-04
• Study Completion: 2024-11-14
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Age:- Patient more than 18yrs and less than 60yrs.
• Gallbladder Stones size :- <15mm.
• All the cases presenting with the clinical signs and symptoms of cholelithiasis diagnosed with USG findings.
• Asymptomatic Patient diagnosed with cholelithiasis through USG.

Exclusion Criteria

• Acute Cholecystitis, complicated cases of cholelithiasis.
• Patient suffering from chronic illness related to CVS, renal, hepatic and GIT.
• Pregnant women, Lactating mothers.
• Patient taking drugs affecting bile acids or serum lipids eg.
• hypolipidaemic drugs, OC pills, phenobarbitone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Reduction in size,	45 days
2)Reduction in no. of gallbladder stones and	45 days
3)improvement in the gallbladder status with use of Kokilaksha Kshara	45 days

Secondary Outcome Measures

Name	Time	Method
Improvement in patient’s Symptoms (nausea, fever,flatulence dyspepsia) based on observations using different scales) relating to cholelithiasis .	from 1st day upto 45th days

Trial Locations

Locations (1)

All India Institute of Ayurveda,New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Ayurveda,New Delhi

🇮🇳South, DELHI, India

Dr Melinda Pereira

Principal investigator

8329914801

melindapereira1996@gmail.com