| CTRI Number |
CTRI/2026/02/103527 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effectiveness of Bootha Chakkara Podi in the Management of Childhood Bronchial Asthma |
|
Scientific Title of Study
|
Preclinical and Clinical Study To Evaluate The Safety and Efficacy of Bootha Chakkara Podi for Sooli Kanam (Childhood bronchial asthma) in children (6 -12 years of age) attending OPD of National Institute Of Siddha - An Open Clinical Trial |
| 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 S PRIYADHARSHINI |
| Designation |
PhD Scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of Kuzhanthai Maruthuvam,
National institute of siddha,
Tambaram sanatorium,
Chennai-600047
Chennai TAMIL NADU 600047 India |
| Phone |
9788999836 |
| Fax |
|
| Email |
spriyadharshini1221@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Meenakshi Sundaram |
| Designation |
Professor and Dean (i/c),Head of the Department |
| Affiliation |
National institute of siddha |
| Address |
Head of the Department,
Department of Kuzhanthai Maruthuvam,
National institute of siddha,
Tambaram sanatorium,Chennai-600047
Chennai TAMIL NADU 600047 India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S PRIYADHARSHINI |
| Designation |
PhD Scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of Kuzhanthai Maruthuvam,
National institute of siddha,
Tambaram sanatorium,
Chennai-600047
Chennai TAMIL NADU 600047 India |
| Phone |
9788999836 |
| Fax |
|
| Email |
spriyadharshini1221@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital,National Institute of siddha,Tambaram sanatorium,Chennai,Tamil nadu,India,Pin code 600047 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 S PRIYADHARSHINI |
National Institute of siddha |
Department of Kuzhanthai Maruthuvam,National Institute of siddha,Tambaram sanatorium,Chennai-600047 Chennai TAMIL NADU |
9788999836
spriyadharshini1221@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: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bootha Chakkara Podi |
Internal medicine administered orally with the dose of 1 to 1.3 gram twice a day with equal quantity of Vellai Poondu Thylam and Honey for 48 days |
| Comparator Agent |
Thaalisaathi chooranam |
Internal medicine admistered orally with the dose of 500 mg twice a day with Honey for 48 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Forced expiratory volume in 1s(FEV1) is between 60% AND 80%.
Peak Expiratory Flow Rate more than 50%[mild,moderate exacerbation]
|
|
| ExclusionCriteria |
| Details |
Forced expiratory volume in 1s(FEV1) is below 60 %.
Peak Expiratory Flow Rate less than 50%[severe exacerbation] |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage reduction in Forced Expiratory Volume changes from baseline to end of the treatment (Day 48) (Minimal Clinical Importance Difference of FEV1 greater than or equal to 15 percent) |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Bootha chakkara podi & Thaalisaathi chooranam in improving clinical symptoms.
Percentage reduction in the symptoms of Childhood Bronchial Asthma through Paediatric Asthma Severity Score(PASS) from baseline to the end of the treatment. |
48 days |
|
|
Target Sample Size
|
Total Sample Size="148" Sample Size from India="148"
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)
|
20/02/2026 |
| 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="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 non-randomised, open-label clinical trial conducted at the Outpatient Department of the National Institute of Siddha to evaluate the efficacy and safety of Siddha formulations in the management of Sooli Kanam (childhood bronchial asthma). A total of 148 children aged 6–12 years diagnosed with Sooli Kanam are enrolled in the study. Participants are allocated into two treatment groups, with 74 participants receiving Bootha Chakkara Podi and 74 participants receiving Thaalisaathi Chooranam .The study drugs are administered orally for a period of 48 days twice a day. Participants are followed throughout the treatment period for assessment of efficacy and safety.Clinical symptoms are assessed on Days 8, 15, 22, 29, 36, and 49. Pulmonary function is evaluated by spirometry, measuring Forced Expiratory Volume in one second (FEV1) and other pulmonary function parameters at baseline Day 1, Day 22, and Day 49. All observations are documented in the Case Report Form .The primary outcome measure is Percentage reduction in FEV1 from baseline to the end of treatment. Secondary outcome measures is to compare the efficacy of Bootha chakkara podi and Thaalisaathi chooranam in improving clinical symptoms.Percentage reduction in the symptoms of Childhood Bronchial Asthma through Paediatric Asthma Severity Score(PASS) from baseline to the end of the treatment. The study aims to generate clinical evidence on the effectiveness and safety of Siddha medicines in childhood bronchial asthma.
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