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CTRI Number  CTRI/2024/05/068028 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Sangkaara vairavan for Bronchial asthma 
Scientific Title of Study   Single centric non-randomized open clinical trial phase II in Swasakasam (Bronchial asthma) with siddha medicine Sangkaara vairavan among patients attending OPD at Government siddha medical college hospital, Chennai 
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 R Sasirekha 
Designation  PG Scholar 
Affiliation  Government siddha medical college 
Address  Room no S1, Government siddha medical college, Arumbakkam, chennai-106

Chennai
TAMIL NADU
600106
India 
Phone  8870496026  
Fax    
Email  sasirekharajendran88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Ujjeevanam 
Designation  Professor 
Affiliation  Government siddha medical college 
Address  Department of Pothu maruthuvam, Government siddha medical college, Arumbakkam, Chennai-106

Chennai
TAMIL NADU
600106
India 
Phone  9884175653  
Fax    
Email  ujjeevanam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R Sasirekha 
Designation  PG Scholar 
Affiliation  Government siddha medical college 
Address  Room no S1, Government siddha medical college, Arumbakkam, chennai-106

Chennai
TAMIL NADU
600106
India 
Phone  8870496026  
Fax    
Email  sasirekharajendran88@gmail.com  
 
Source of Monetary or Material Support  
Government siddha medical college, Arumbakkam, Chennai-106 
 
Primary Sponsor  
Name  Dr R Sasirekha 
Address  Room no S1, Government siddha medical college, Arumbakkam, Chennai 
Type of Sponsor  Other [Self] 
 
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 R Sasirekha  Government Siddha Medical College, Arumbakkam  Room No S1, PG Department Of Pothu Maruthuvam,Arumbakkam
Chennai
TAMIL NADU 		 8870496026

sasirekharajendran88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee GSMC Chennai   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 
Comparator Agent  NIL  NIL 
Intervention  Sangkaara vairavan  The Siddha drugs will be powdered in mortar and pestle It will be sieved by white cloth and grinded with ginger juice until karkam patham has been obtained This karkam will be roll into pills of 130mg and it will be dried in a shade Dose 1 pill(130mg) bd after food with ginger juice for 48 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cough with tenacious sputum
Dyspnea
H/O Wheeze or without wheeze
Chest tightness
Peak expiratory flow rate between 60-80% 
 
ExclusionCriteria 
Details  K/C/O Chronic bronchitis
K/C/O Bronchiectasis
K/C/O Pulmonary TB
K/C/O Congestive cardiac failure
K/C/O Status asthmaticus
Pregnancy and lactating mothers

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Outcome will be assessed by reduction in clinical symptoms like wheeze, dyspnea and chest tightness  48 days 
 
Secondary Outcome  
Outcome  TimePoints 
assessing peak expiratory flow rate from moderate persistent (60-80%) to mild persistent & mild intermittent (≥80%)  48 days 
 
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)   02/09/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sasirekharajendran88@gmail.com].

  6. For how long will this data be available start date provided 02-06-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Bronchial asthma is an important public health problem at the global level. It is a chronic reversible inflammatory destructive disease of the airways characterized by recurrent paroxysmal attacks of dyspnea chiefly expiratory in nature accompanied by wheeze which may subside spontaneously or with treatment. There are complex and confounding associations and relationships with infections and infestations, air pollution, tobacco smoking and environmental tobacco smoke exposure. According to a global asthma report among India’s 1.31 billion people, about 6% of children and 2% of adults have asthma. In India, statistical data shows that 0.92%of women and 3.04% of men were suffering from asthma.

Thus, in Siddha system of Medicine, there are unique combination of medicines, which have solution to the present scenario of Bronchial asthma. One such combination is SANGKAARA VAIRAVAN which will be cost effective and reliable. The method of preparation of the medicine is easy and the raw drugs are also easily available.

The aim of the study is the management of SWASAKASAM (BRONCHIAL ASTHAMA) with siddha medicine SANGKAARA VAIRAVAN  and the objective is to determine the therapeutic efficacy and safety profile of the siddha medicine SANGKAARA VAIRAVAN  in the management of SWASAKASAM (BRONCHIAL ASTHAMA). As the literary evidences support the usage of medicine, in the disease, hypothesis is created such a way that the efficacy of SANGKAARA VAIRAVAN will be a better solution for SWASAKASAM (BRONCHIAL ASTHAMA). 
 
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