| CTRI Number |
CTRI/2026/02/104878 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Vasuvaasi Chooranam in patients with Bronchial Asthma (Swasakasam) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF VASUVAASI CHOORANAM IN THE MANAGEMENT OF SWASAKASAM (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 K ABINAYA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palyamkottai |
| Address |
Op number 10, PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8870580738 |
| Fax |
|
| Email |
abinayakanagaraj98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S JUSTUS ANTONY |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Op number 10, PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S JUSTUS ANTONY |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Op number 10, PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002 |
| 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 K ABINAYA |
Government Siddha Medical College and Hospital |
Op number 10, Department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Thiruvananthapuram Road, Palayamkottai.
Tirunelveli
TAMIL NADU |
8870580738
abinayakanagaraj98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College, Palayamkottai, Tirunelveli-627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vasuvaasi chooranam |
Dosage:1 gram thrice a day for 40 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults who are diagnosed with bronchial asthma
2.Patients with a clinical symptoms of swasakasam-recurrent episodes of wheezing, chest tightness, shortness of breath and dry cough, worse at night or early morning
3.History of symptoms triggered by allergens, climatic changes
4.Patients willing to provide blood samples for laboratory investigations |
|
| ExclusionCriteria |
| Details |
1.Patients with pulmonary Tuberculosis
2.Patients with status asthmaticus
3.Patients with chronic bronchitis, chronic bronchiectasis
4.Patients with heart failure
5.Patients with renal disease
6.Pregnancy and Lactating mothers
7.Diabetes mellitus
8.Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the severity and frequency of clinical symptoms of Swasakasam (Bronchial Asthma), including shortness of breath, chest tightness, wheezing, and dry cough
|
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of Asthma Control Questionnaire (ACQ) score following treatment
2.Evalaution of absolute eosinophil count following treatment
3.Evaluation of peak expiratory flow rate
(PEFR) following treatment |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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
|
This study is a prospective, open labelled, single arm, non-randomized, single centric, phase II clinical trial to evaluate the effectiveness of VASUVAASI CHOORANAM in the management of Swasakasam (Bronchial Asthma). The trial drug will be administered orally at a dose of 1 gram thrice a day for 40 days in 40 diagnosed cases of Swasakasam (Bronchial Asthma). The study aims to assess therapeutic outcomes based on improvement in clinical symptoms and changes in relevant laboratory, respiratory, and siddha parameters(including envagai thervu, neerkuri, neikuri). Standard physicochemical, phytochemical, bio chemical analysis, and pharmacological analysis of the trial drug will be performed.
|