| CTRI Number |
CTRI/2020/05/025074 [Registered on: 08/05/2020] Trial Registered Prospectively |
| Last Modified On: |
08/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study of dhanvayasa kwatha and sarshap taila in management of sheetapitta |
|
Scientific Title of Study
|
open randomized controlled study of dhanvayasa kwatha and sarshap taila abhyanga in sheetapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr dattatrya nikam |
| Designation |
MD kayachikitsa |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduation Research Training Center Ashta |
| Address |
Hon shri annasaheb dange ayurved medical college and post graudation research training center ashta tal walwa dist sangli maharashtra 416301 sangli MAHARASHTRA 416301 INDIA
Hon shri annasaheb dange ayurved medical college and post graudation research training center ashta tal walwa dist sangli maharashtra 416301 sangli MAHARASHTRA 416301 INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
8390761674 |
| Fax |
|
| Email |
drdattatryanikam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr dattatrya nikam |
| Designation |
MD kayachikitsa |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduation Research Training Center Ashta |
| Address |
Hon shri annasaheb dange ayurved medical college and post graudation research training center ashta tal walwa dist sangli maharashtra 416301 sangli MAHARASHTRA 416301 INDIA
Hon shri annasaheb dange ayurved medical college and post graudation research training center ashta tal walwa dist sangli maharashtra 416301 sangli MAHARASHTRA 416301 INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
8390761674 |
| Fax |
|
| Email |
drdattatryanikam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
dr dattatrya nikam |
| Designation |
MD kayachikitsa |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduation Research Training Center Ashta |
| Address |
Hon shri annasaheb dange ayurved medical college and post graudation research training center ashta tal walwa dist sangli maharashtra 416301 sangli MAHARASHTRA 416301 INDIA
Hon shri annasaheb dange ayurved medical college and post graudation research training center ashta tal walwa dist sangli maharashtra 416301 sangli MAHARASHTRA 416301 INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
8390761674 |
| Fax |
|
| Email |
drdattatryanikam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Salwa Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
annasaheb dange ayurved medical college ashta |
| Address |
hon shri annasaheb dange ayurved medical college and post graduation research training centre tal walwa dist sangli 416301 |
| Type of Sponsor |
Private 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 Swapnja Laxman Tambhale |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
Hon Shri Annasaheb Dange Ayurved Medical College and post graduation research training centre Ashta Dist sangli
Sangli
MAHARASHTRA |
8975339846
dr.swapnatambhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L500||Allergic urticaria, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
patient with clinical signs and symptoms of sheetapitta decribed in ayurvedic text book age 20 to 40 years both sex patients selected |
|
| ExclusionCriteria |
| Details |
patients suffering from any other systemic disorders like HTN DM IHD and HIV
history of anaphylaxis to medicine
other skin deseases like psoriasis eczema |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of dhanvayasa kwatha and sarshap taila in management of sheetapitta |
18 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study mode of action of Dhanvayasa Maatha and sarshap taila abhyanga |
14 days |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
10/05/2020 |
| 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="0"
Months="6"
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)?
|
|
Brief Summary
|
Clinical research named as "open randomized controlled study of Dhanvayasa Kwatha and sarshap taila abhyanga in sheetapitta " will be conducted with support of shri Annasaheb Dange Ayurved Medical college Ashta. |