| CTRI Number |
CTRI/2026/02/104866 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to evaluate the Efficacy of Sombu theeneer and Sombu Theeneer with Siddhar Yoga Maruthuva Muraigal in the Management of Swasakasam (Bronchial asthma) |
|
Scientific Title of Study
|
An open-labelled, double-arm, non-randomized Phase II clinical trial to evaluate the Efficacy of Sombu Theeneer and Sombu Theeneer with Siddhar yoga Maruthuva Muraigal 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 Shilpa B |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and hospital Palayamkottai |
| Address |
Second year
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9597680943 |
| Fax |
|
| Email |
b.shilpapriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MD Siddha |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and hospital Palayamkottai |
| Address |
Professor and HOD
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MD Siddha |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and hospital Palayamkottai |
| Address |
Professor and HOD
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| The OPD and IPD facilities and Central library of Government Siddha Medical College and hospital Palayamkottai Tirunelveli 627002 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Dr Shilpa B |
| Address |
Second year
Department of Siddhar Yoga Maruthuvam
Government siddha medical College and hospital Palayamkottai
Tirunelveli
Tamilnadu India |
| 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 Shilpa B |
Government Siddha Medical College and hospital Palayamkottai |
Department of Siddhar Yoga Maruthuvam, Government Siddha Medical College and hospital
Palayamkottai,
Tirunelveli ,
Tirunelveli
TAMIL NADU |
95976 80943
b.shilpapriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government siddha medical College and hospital Palayamkottai Tirunelveli Tamilnadu India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sombu Theeneer (Internal medicine) |
Oral administration of 20ml of Sombu Theeneer with Luke warm water twice a day for a duration of 48 days |
| Comparator Agent |
Sombu Theeneer with Siddhar Yoga Maruthuva Muraigal |
Oral administration of 20ml of Sombu Theeneer with Luke warm water twice a day along with the practice of Siddhar Yoga Maruthuva Muraigal ( Breathing techniques and asanas) for a duration of 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
If any 3 of the following symptoms of asthma are present, the participants will be included for the study
Mild and moderate (episodic) asthmatic symptoms
Breathless
Wheezing with unproductive cough
When sputum is expelled by cough, the symptoms are relieved, otherwise dyspnea will be severe
Obstructive sleep apnea
Allergic rhinitis |
|
| ExclusionCriteria |
| Details |
Chronic bronchitis
Pulmonary tuberculosis
Sinusitis
Interstitial lung disease
Bronchiectasis
Any other serious systematic illness
Pregnant and lactation
Patient who had allergy with trail drug
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the clinical efficacy of Sombu theeneer and Sombu Theeneer With Siddhar Yoga
Maruthuva Muraigal in management of Swasakasam (Bronchial Asthma).
To assess the Improvement in symptom scoring using standardized asthma control tool such as
Asthma Control Test before and after the trail in both groups |
Baseline(0th day) and the end of the intervention period (48th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in lung function using Peak Expiratory Flow Rate (PEFR), measured
with a peak flow meter before and after the intervention in both groups. |
Baseline(0th day) and the end of the intervention period (48th day) |
|
|
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)
|
10/03/2026 |
| 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 Yet Recruiting |
| 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
|
It is an open labelled double arm non randomised phase II clinical trial to evaluate the efficacy of Sombu Theeneer and Sombu Theeneer with Siddhar Yoga Maruthuvam Muraigal Group A will be given oral administration of 20ml of Sombu Theeneer (Internal medicine) with Luke warm water twice a day for a duration of 48 days Group B also be given oral administration of 20ml of Sombu Theeneer with Luke warm water along with the practice of Siddhar Yoga Maruthuvam Muraigal ( Breathing techniques and asanas) for a duration of 48 days
|