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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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