| CTRI Number |
CTRI/2024/07/071293 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| 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 Drakshadi churna and Vasadi Kwatha on Tamaka Shwasa (Bronchial Asthma) |
|
Scientific Title of Study
|
A Comparative Clinical Study of Drakshadi Churna and Vasadi Kwatha in the Management of Tamaka Shwasa w.s.r to Bronchial Asthma |
| 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 vikas yadav |
| Designation |
PG Scholar |
| Affiliation |
Kunwar shekhar vijendra ayurved medical college and research centre,Shobhit university |
| Address |
Deparment of Kayachikitsa, Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre,Shobhit university.
Adarsh institutional area,Babu vijendra marg,Gangoh,Saharanpur
U.P. India-247341
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9760623261 |
| Fax |
1331234500 |
| Email |
drvikasyadav228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vikas yadav |
| Designation |
PG Scholar |
| Affiliation |
Kunwar shekhar vijendra ayurved medical college and research centre,Shobhit university |
| Address |
Department of Kayachikitsa, Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre,Shobhit university.
Adarsh institutional area,Babu vijendra marg,Gangoh,Saharanpur
U.P. India-247341
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9760623261 |
| Fax |
1331234500 |
| Email |
drvikasyadav228@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A P Singh |
| Designation |
Professor and HOD Dept. of Kayachikitsa |
| Affiliation |
Kunwar shekhar vijendra ayurved ayurved medical college and research centre,Shobhit university |
| Address |
Department of Kayachikitsa,Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre,Shobhit university.
Adarsh institutional area,babu vijendra marg,Gangoh,Saharanpur
U.P. India-247341
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9410088322 |
| Fax |
1331234500 |
| Email |
apsingh11264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar shekhar vijendra ayurved medical college and research centre,Shobhit university, Adarsh institutional area,Babu vijendra marg,Gangoh,Saharanpur U.P. India-247341 |
|
|
Primary Sponsor
|
| Name |
Kunwar shekhar vijendra ayurved medical college and research centre Shobhit university |
| Address |
Adarsh institutional area,Babu vijendra marg,Gangoh,Saharanpur,
U.P. India-247341 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vikas Yadav |
Kunwar shekhar vijendra ayurved medical college and research centre, shobhit university |
OPD No-1,Department of Kayachikitsa, Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre,Shobhit university
Adarsh institutional area,Babu Vijendra marg,Gangoh-247341
Saharanpur
UTTAR PRADESH |
9760623261
Drvikasyadav228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar shekhar vijendra ayurved medical college and research centre,Shobhit university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J709||Respiratory conditions due to unspecified external agent. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi Churna, Reference: Madhav Chikitsa- Dr M.S. Krishnamurty, Chapter-12 Hiccashwasa Chikitsa, Shlok no-10, Page no-80., Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madhu & Ghrit), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasadi Kwatha, Reference: Yogratnakar- Acharya Siddhinandan Mishra, Chapter-14 Shwasarogadhikar, Shlok no-39, Page no-445., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Subject of age group between 18 to 60 years and irrespective of caste, sex, religion, occupation and socio-economy status.
2-Subject presented with sign & symptoms of Tamaka Shwasa
3-Disease chronicity less than 10 years
4-Subject willing to give informed consent to participate for 45days |
|
| ExclusionCriteria |
| Details |
1- Severe Bronchial asthma
2-Statusasthmaticas and chronic obstructive pulmonary disorder
3-K/C/O-Infectivepulmonary pathology(Empyema,Abscess,Tuberculosis)
4-Subject having any systemic disorder ie.K/C/O-Renal and Cardiac disorder
5-Subject having complication like emphysema,pneumonia,malignancy and severe anaemia
6-Subject addicted to smoking
7-Womens who are pregnant and breast feeding
8-Subjects having vigorous exercise |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of Tamaka shwasa |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement will be assessed on the basis of relief found in cardinal symptoms of disease |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the efficacy of Drakshadi Churna and Vasadi Kwatha in the management of Tamaka shwasa. This study is a single center, open labelled, randomized, interventional comparing the safety and efficacy of drakshadi churna 6gm twice a day and Vasadi kwatha 48ml twice a day for 18 months in 70 patients with Tamaka shwasa that will be conducted. |