| CTRI Number |
CTRI/2020/08/027335 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
12/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Pleehodara Roga by Sharpunkha Kshara |
|
Scientific Title of Study
|
A Clinico-Anatomical Study of Pleeha in Pleehodara Roga W.S.R. to Therapeutic Effect of Sharpunkha Kshara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anop Singh |
| Designation |
M.D. Scholar |
| Affiliation |
University College of Ayurveda Jodhpur |
| Address |
Univrsity College of Ayurveda Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9461452184 |
| Fax |
|
| Email |
dranopsinghrathore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANOP SINGH |
| Designation |
M.D. SCHOLAR |
| Affiliation |
UNIVERSITY COLLEGE OF AYURVEDA JODHPUR |
| Address |
UNIVERSITY COLLEGE OF AYURVEDA JODHPUR RAJASTAHN
RAJASTHAN
342037
India |
| Phone |
9461452184 |
| Fax |
|
| Email |
dranopsinghrathore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar Sharma |
| Designation |
Associate Professor Rachana Sharir |
| Affiliation |
University College of Ayurveda Jodhpur Rajasthan |
| Address |
Dept of Rachana Sharir Ground Floor Room no 53 University College of Ayurveda Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166216760 |
| Fax |
|
| Email |
rksharma_jumbo@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University College of Ayurveda Kadvad Nagaur Road Jodhpur Rajasthan 3420037 |
|
|
Primary Sponsor
|
| Name |
University College of Ayurveda |
| Address |
University College of Ayurveda Nagaur Road Kadvad Jodhpur Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Rakesh Kumar Sharma |
OPD Campus of University College of Ayurveda Rajasthan |
OPD no 3 Dept of Kayachikitsa
Jodhpur
RAJASTHAN |
9166216760
rksharma_jumbo@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D731||Hypersplenism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Medicines Provides in OPD / IPD |
Medicines use in Pleehodara Roga |
| Intervention |
Sharpunkha Kshara |
1-3 grams for 30 days According to Patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the classical signs and symptoms of Pleehavridhi (splenomegaly). |
|
| ExclusionCriteria |
| Details |
Patients with other Systemic Diseases like Diabetes Mellitus, Malignancy, CHD, etc.
HbsAg and HIV Positive Patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Subjective and Objective criteria. |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the Efficay of Sharpunkha Kshara |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Randomized Parallel
Group Clinical Trial of 30 Patients Which are Divided in 3 Groups. Each Group
Consist of 10 Patients. First Group Will be treated with Medicine Prescribed in
OPD. Second Group Will be treated with Medicines Provide in OPD/IPD +
Sharpunkha Kshara.Third Group Will Be Treated with Only Sharpunkha Kshara |