| CTRI Number |
CTRI/2020/02/023482 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
19/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of haridradi churna in the management of Tamak Shwasa |
|
Scientific Title of Study
|
OPEN RANDOMIZED CONTROL CLINICAL STUDY ON EFFICACY OF HARIDRADI CHURNA IN THE MANAGEMENT OF TAMAK SHWASA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dattatray Nikam |
| Designation |
MD Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Training Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduation Training Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8390761674 |
| Fax |
|
| Email |
drdattatryanikam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dattatray Nikam |
| Designation |
MD Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Training Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduation Training Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8390761674 |
| Fax |
|
| Email |
drdattatryanikam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatray Nikam |
| Designation |
MD Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Training Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduation Training Center Ashta Tal Walwa Dist Sangli
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 Walwa Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Annasaheb dange ayurved medical college Ashta |
| Address |
Annasaheb dange ayurved medical college and Post Graduation Research Training Center Tal Walwa Dist Sangli |
| 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 Amol Ghodke |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduation Research Training Center Ashta Dist Sangli
Sangli
MAHARASHTRA |
7796131333
amolg233879@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Elaadi Churna |
2 gm bd 21 days orally |
| Intervention |
Haridradi Churna |
2gm bd 21 days orally |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical features of Tamaka Shwasa that is
Shwasa krucchata
Peenasa
Ghurghuratwam
Sakapha kasa
Shwasa vega
Patients with history of Tamaka shwasa less than 5 years
|
|
| ExclusionCriteria |
| Details |
Patients aged less than 16 years and more than 60 years
Patients with history of Tamak shwasa more than 5 years
Patient presenting with Tamak shwasa due to the complication of other systemic diseases like Pneumonia Tuberculosis Lung carcinoma Cardiac asthma will be excluded
Pregnant womens and lactating mothers will be excluded
Emergency condition of the patient who requires oxygen inhalation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE EFFICACY OF HARIDRADI CHURNA IN THE MANAGEMENT OF TAMAK SHWASA |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE MODE OF ACTION OF HARIDRADI CHURNA |
21 DAYS |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
21/02/2020 |
| 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 project named as " Randomised control study of haridradi churna in the management of tamak shwasa " will be conducted with support of Hon Shri Annasaheb Dange Ayurved Medical College Ashta |