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CTRI Number  CTRI/2024/06/069090 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [pilot study]  
Study Design  Single Arm Study 
Public Title of Study   A study on effectiveness of Bringaraja thailam for the management of sooli kanam 
Scientific Title of Study   An pilot study to assess the effectiveness of Bringaraja thailam for the management of childhood 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 Karthika Prakasan 
Designation  PG scholar 
Affiliation  Research and hospital, National institute of siddha 
Address  Ayothidoss Pandithar hospital Department of kuzhanthai maruthuvam National Institute of Siddha Tambaram sanatorium Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  8075114626  
Fax    
Email  karthikaprakasan268@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Vennila 
Designation  Associate Professor 
Affiliation  National institute of siddha 
Address  Ayothidoss Pandithar hospital Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9789093986  
Fax    
Email  gvennils@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karthika Prakasan 
Designation  PG scholar 
Affiliation  National institute of siddha 
Address  Ayothidoss Pandithar hospital Department of kuzhanthai maruthuvam National Institute of Siddha Tambaram sanatorium Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  8075114626  
Fax    
Email  karthikaprakasan268@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar hospital National Institute of siddha Tambaram sanatorium Chennai 600047 Kancheepuram district Tamilnadu India 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  yothidoss Pandithar Hospital National Institute of siddha Tambaram Sanatorium Chennai 47 
Type of Sponsor  Research institution and hospital 
 
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 Karthika Prakasan  Ayothidoss pandithar hospital  Room no 16 Department of Kuzhanthai Maruthuvam National institute of siddha Tambaram sanatorium Chennai Kancheepuram Tamilnadu India
Kancheepuram
TAMIL NADU 
8075114626

karthikaprakasan268@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
he Institutional Ethics Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bringaraja thailam as internal medicine  Ingredients karisalai Eclipta alba Gingelly oil ROUTE OF ADMINISTRATION Internal DOSAGE 6 to 8 years 0.5 ml 9 to 12 years 1 to 1.5 ml DURATION 48 DAYS 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Children of both sex in the age group of 6 to 12 years

2 Is diagnosed with asthma by following the Global Initiative for Asthma (GINA) guidelines and St Georges respiratory questionnaire

3 Children having FEV1 greater than 60 percentage TO less than 80 percentage

4 Patient willing to co-operate for spirometry test

5 Parent willing to sign the informed consent form
 
 
ExclusionCriteria 
Details  1 H/O Pulmonary tuberculosis

2 H/O Bronchiectasis

3 Subject unable to do Spirometry

4 Any other serious illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline   Effectiveness of the trial drug will be assessed by spirometry before and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the symptoms assessed by GINA Global Initiative for Asthma Guidelines 2022 and St Georges Respiratory questionnaire

 
Before and after treatment 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   20/08/2024 
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="0"
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  

INTRODUCTION: This is an open non randomized clinical trail to determine the effectiveness of siddha herbal formulation Bringaraja thailam. Sooli Kanam has been described in the siddha literatures as the diseases frequently occuring in children . According to siddha texts, It is characterized by prolonged expiration and expiratory wheeze, prolonged cough, abdominal bloating and discomfort due to mouth breathing. It can be closely compared withchildhood Asthma. Asthma is a chronic inflammatory disease characterized by airway obstruction, airway hyper responsiveness manifest as wheeze, cough, shortness of breath and chest tightness. .Asthma tends to affect about 10% children globally. Recent data have shown that asthma continues to affect 6 million school aged children with approximately half of these children experiencing asthma attack each year. MATERIALS AND METHODS: A total of 10 patients within age limit of 6 to 12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSIONS: Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline and also assess  the  improvement in the symptoms by GINA Global Initiative for Asthma Guidelines 2022 and St. Georges respiratory questionnaire.

 

 
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