Main
|
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: |
|
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
|
Source(s) of Monetary Support
|
Parul Institute of Ayurved
|
Ethics review
|
Status: Approved
Approval date: 22/10/2016
Contact:
Institutional Ethics committee
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|