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CTRI Number  CTRI/2014/08/004825 [Registered on: 05/08/2014] Trial Registered Retrospectively
Last Modified On: 14/08/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Management of Bronchial asthama 
Scientific Title of Study   Clinical Evaluation of Kodagasalai Ennai in the treatment of Suzhimantham in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KElavarasan 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone  9952144747  
Fax    
Email  drelavarasanmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  KElavarasan 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium, Chennai-47


TAMIL NADU
600047
India 
Phone  9952144747  
Fax    
Email  drelavarasanmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MMeenakshi Sundaram 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone  9444214582  
Fax    
Email  mmssiddha@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam 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 
DrKElavarasan  National Institute of Siddha   Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU 
9952144747

drelavarasanmd@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  Intermittent fever, wheezing, lack of appetite,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KODAGASALAI ENNAI Internal drug for Suzhimaantham  KODAGASALAI ENNAI is a poly herbal drug- 160 mg- OD dose for 7 days.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  3.00 Year(s)
Gender  Both 
Details  Intermittent fever
Wheezing
Insomnia
Hiccough
Lack of appetite
Dyspnoea
Indrawing of respiratory muscles 
 
ExclusionCriteria 
Details  Jaundice
Enteric fever
Pneumonia
Congenital heart disease
Any other serious illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Results and observation during the study inclusive of clinical improvements  2-3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Results and observation during the study inclusive of clinical improvements  Before treatment and after treatment 
 
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)   09/06/2014 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   After completion of study 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a single arm open clinical trial to find out the thereapeutic effect of Kodagasaalai Ennai (Intenal Medicine) a herbal drug Containing Justica adhathoda, Allium sativum, Occimum sanctum, Lecus caspera, Tinospora cordifolia, Myrstica fragrans, Asafoeitida, Castor oil, Ox gall, Picorrhiza kurroa, Azima tetracantha, Cuscuta reflex administered orally once a day.  The drug dosage is 160 mg for seven days. The clinical assessment and laboratory investigations will be recorded in case report form(CRF) for all patients.After completion of the trial all the data will be analysed statisticaly and the research reports will be published in Indian journal of medical research.

 
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