| CTRI Number |
CTRI/2023/03/050203 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effect of Kokilaksha Kshara in patients with Gall Bladder Stones. |
|
Scientific Title of Study
|
Efficacy of Kokilaksha Kshara in Pittashaya Ashmari W.S.R to Cholelithiasis – A Single Arm Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Melinda Minin Pereira |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
OPD No.104, 1st Floor, Hospital Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi.
South
DELHI
110076
India |
| Phone |
8329914801 |
| Fax |
|
| Email |
melindapereira1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Badwe |
| Designation |
Professor and HOD, Dept. of Shalya Tantra, AIIA |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no.504,5th Floor, Academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi.
South
DELHI
110076
India |
| Phone |
9011060498 |
| Fax |
|
| Email |
dryogesh.badwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Melinda Minin Pereira |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
OPD No.104, 1st Floor, Hospital Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi.
South
DELHI
110076
India |
| Phone |
8329914801 |
| Fax |
|
| Email |
melindapereira1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda,New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura Road, Gautam Puri, Sarita Vihar, New Delhi, Delhi
110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Melinda Pereira |
All India Institute of Ayurveda,New Delhi |
OPD NO.104,Shalya Tantra Department, 1st Floor, Hospital Block, All India Institute of Ayurveda, Mathura Road, Sarita Vihar, New Delhi.
South
DELHI |
8329914801
melindapereira1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of All India Institute of Ayurveda, New Delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K802||Calculus of gallbladder without cholecystitis. Ayurveda Condition: PITTAJA-ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kokilaksha, Reference: Bhavaprakash,Rajnighantu, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Reduction in size,
2)Reduction in no. of gallbladder stones and
3)improvement in the gallbladder status with use of Kokilaksha Kshara |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in patient’s Symptoms (nausea, fever,flatulence dyspepsia) based on observations using different scales) relating to cholelithiasis . |
from 1st day upto 45th days |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/04/2023 |
| Date of Study Completion (India) |
14/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/11/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
will be done in future |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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 |