| CTRI Number |
CTRI/2024/03/064801 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the efficacy of bharangi and nagar kwath in the managment of tamak swasa vyadhi ( Bronchial Asthma) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Bharangi Nagar Kwath (Decoction) in The Tamak Swasa (Bronchial Asthma) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renuka Sahu |
| Designation |
MD Scholar Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
|
| Address |
Department of Kayachikitsa opd no 05 ground floor Dr DY Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9459608600 |
| Fax |
|
| Email |
dr.renu19setu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayak N Joshi |
| Designation |
HOD of Rog Nidan Evum Vikriti Vigyan Department |
| Affiliation |
|
| Address |
Department of Kayachikitsa opd no 05 ground floor Dr DY Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8275648036 |
| Fax |
|
| Email |
vinayak.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renuka Sahu |
| Designation |
MD Scholar Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan opd no 15 ground floor Dr DY Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9459608600 |
| Fax |
|
| Email |
dr.renu19setu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurved and Research center Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
Renuka Sahu |
| Address |
Dr D Y Patil college of Ayurved and Research center Pimpri Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Renuka Sahu |
Dr D Y Patil College Of Ayurved and Research Center Pimpri Pune Pimpri Pune |
OPD and IPD of Rog Nidan Evum Vikriti Vigyan Department.
Pune
MAHARASHTRA |
9459608600
dr.renu19setu@gmail.com |
|
|
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:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bharangi, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Nagar, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting with signs and symptoms of Tamak Swasa (Bronchial Asthma) |
|
| ExclusionCriteria |
| Details |
1 Patients not willing for trial
2 Age below 18 years and above 60 years
3 Any Endocrine disorders like diabetes Thyroid dysfunction etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of Bharangi nagar kwath on Tamak swasa patients |
3 days study with 1 follow up ( 0,3 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/04/2024 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to see the effectiveness of Bharangi Nagar Kwath in Tamak Swas Vyadhi (Bronchial Asthma). The study will be conducted with 30 patients showing signs and symptoms of Tamak Swas Vyadhi (Bronchial Asthma), they will be administered with Bharangi Nagar Kwath twice a day for three days and follow up will be done on third day and conclusion will be drawn on the basis of proper statistical methods. |