| CTRI Number |
CTRI/2024/07/070064 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pushkarmoola churna and Vasa sawarasa in bronchial asthma |
|
Scientific Title of Study
|
Comprative study of pushkarmoola churna and vasa swarasa in management of tamak shwasha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anish chouhan |
| Designation |
MD Scholar |
| Affiliation |
Post graduate institute of Ayurveda DSRRAU Jodhpur |
| Address |
Room no 137 PG Department of Kriya Sharir Post graduate institute of Ayurveda DSRRAU Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610888854 |
| Fax |
|
| Email |
dranishchouhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh chandra Sharma |
| Designation |
Associate Professor |
| Affiliation |
Post graduate institute DSRRAU Jodhpur |
| Address |
Room no 142 Department of Kriya Sharir Post graduate institute of Ayurveda DSRRAU Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7062731100 |
| Fax |
|
| Email |
dr_dcsharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anish Chouhan |
| Designation |
MD Scholar |
| Affiliation |
Post graduate institute DSRRAU Jodhpur |
| Address |
Room no 137 Department of Kriya Sharir Post graduate institute of Ayurveda DSRRAU Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610888854 |
| Fax |
|
| Email |
dranishchouhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of Ayurveda DSRRAU Jodhpur |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of ayurveda DSRRAU Jodhpur |
| Address |
Room no 137 Post graduate institute of ayurveda DSRRAU jodhpur Rajasthan India 342037 |
| 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 Anish Chouhan |
Post graduate institute of Ayurveda |
Room no 137 Department of Kriya Sharir Post graduate institute of Ayurveda DSRRAU Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN |
9610888854
dranishchouhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post graduate institute of Ayurveda DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasa Sawarasa, Reference: Raj nighntu Shtahvyadi varga 49 Shlok no , Route: Oral, Dosage Form: Swaras/ Juice, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pushkar Moola Churna, Reference: Dhanvantri nighantu Guduchyadi varga Shlok no 72 - 74, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 30 to 60 years
Classical symptoms of Tamak Shwasa with emphasis to symptoms of bronchial asthma like dyspnoea, wheezing, chest tightness and cough worsening particularly at night and in early hours of the morning
History of frequency of attack of once a week or more |
|
| ExclusionCriteria |
| Details |
Tuberculosis
Bronchial Carcinoma
COPD
Pleural Effusion
Cardiac Asthma
Emphysema |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimate of asthma frequency attack which is reduced by the intervention |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving the quality of life and reduce dependency on other medicine |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/07/2024 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparative study of Pushkar Moola Churna And Vasa Sawaras in Tamak Shwasa (Bronchial Asthma) Dose Pushkar moola churna 1-3 gm Dose Vasa Swarasa 5-10 ml Age Criteria 30-60 years End result Reduce attack of Bronchial Asthma And improving the quality of life |