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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/04/008389
Date of registration: 21-04-2017
Prospective Registration: Yes
Primary sponsor: Parul Institute of Ayurved and Hospital
Public title: MANAGEMENT OF GALLSTONE WITH AYURVEDA
Scientific title: CLINICAL AND EXPERIMENTAL EVALUATION OF PANEEYA KSHARA IN THE MANAGEMENT OF CHOLELITHIASIS W.S.R TO PITTASHAYA ASHMARI
Date of first enrolment: 01-05-2017
Target sample size: 30
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16986
Study type:  Interventional
Study design:  Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
 
Phase:  Phase 1/ Phase 2
Countries of recruitment
India
Contacts
Name: Dr. Sathish H. S.   
Address:  Department of Shalya Tantra, Parul Institute of Ayurved, Parul University, Limda Parul University, Limda 391760 Vadodara, GUJARAT India
Telephone: 9624653733
Email: ayursathishhs@gmail.com
Affiliation:  Parul Institute of Ayurved
Name: Dr. Sathish H. S.   
Address:  Department of Shalya Tantra, Parul Institute of Ayurved, Parul University, Limda Parul University, Limda 391760 Vadodara, GUJARAT India
Telephone: 9624653733
Email: ayursathishhs@gmail.com
Affiliation:  Parul Institute of Ayurved
Key inclusion & exclusion criteria
Inclusion criteria: Patients presenting with clinical features of Cholelithiasis,

Asymptomatic patients who are diagnosed to have Cholelithiasis accidentally by USG

with multiple stones which is 1cm -5cm


Exclusion criteria: •Patients who are contraindicated for Paneeya kshara by Susrutha.

•Patients with Cholelithiasis associated with complications such as acute obstructive cholecystitis, acute pancreatitis, liver failure, carcinoma of gallbladder.

•Uncontrolled other systemic disorders



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Cholelithiasis
Intervention(s)
Intervention1: Makkaya Kshara/Silk hairs of corn/Zea mays Linn.: 125mg-250mg BD with Honey,60days,oral route

Intervention2: Intervention-Makkaya Kshara: orally 125mg-250mg BD with honey for 60 days.
Control Intervention1: not applicable: not applicable
Primary Outcome(s)
Dissolve of Gall Bladder StoneTimepoint: 8 Weeks
Secondary Outcome(s)
pain

vomitting

nausea

dyspepsiaTimepoint: 8 weeks
Secondary ID(s)
NIL
Source(s) of Monetary Support
Parul Institute of Ayurved
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 22/10/2016
Contact:
Institutional Ethics committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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