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CTRI Number  CTRI/2022/11/047659 [Registered on: 25/11/2022] Trial Registered Prospectively
Last Modified On: 21/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   SOOLIKANA NEI FOR WHEEZING IN CHILDREN 
Scientific Title of Study   Phase II Non Randomised Clinical Study On Sooli Kanam (Bronchial Aathma) In Children WITH THE EVALUATION OF SIDDHA TRIAL DRUG SOOLI KANA NEI 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Komalesvaran R 
Designation  PG Scholar 
Affiliation  Government Siddha medical college  
Address  Room no 25 Department of PG Kuzhanthai maruthuvam Government Siddha medical college Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  7373942096  
Fax    
Email  komalesvaran2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B Malarvizhi MDs 
Designation  HOD and Professor 
Affiliation  Government Siddha medical college  
Address  Room no 25 Department of PG Kuzhanthai maruthuvam Government Siddha medical college Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  9444487063  
Fax    
Email  malarvizhiisha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Komalesvaran R 
Designation  PG Scholar 
Affiliation  Government Siddha medical college  
Address  Room no 25 Department of PG Kuzhanthai maruthuvam Government Siddha medical college Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  7373942096  
Fax    
Email  komalesvaran2@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha medical college Arumbakkam 
 
Primary Sponsor  
Name  Government Siddha medical college 
Address  No 6 Anna arch Road NSK nagar Arumbakkam chennai 600106 
Type of Sponsor  Government medical college 
 
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 Komalesvaran R  Government Siddha medical college  Room no 25 Department of PG Kuzhanthai maruthuvam NSK Nagar Arumbakkam
Chennai
TAMIL NADU 
7373942096

komalesvaran2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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 
Comparator Agent  NIL   NIL 
Intervention  Sooli Kana Nei   Sooli Kana Nei Dosage 2-5 grams bd Duration 14days 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Cough without expectoration
Dyspnea
Running nose
Chest tightness
Wheezing 
 
ExclusionCriteria 
Details  Primary complex
Hypersensitivity Pneumonitis
Lung Abscess
Cystic fibrosis
Bronchiolitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is assesed by reduction in clinical symptoms and Modified Asthma Scale before and after treatment  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
It is assessed by comparing the safety parameters before and after treatment.
Along with this investigational changesof reduction in ESR level, Eosinophil counts, WBC and increase level of HB 
14 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)   01/12/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a single Non Randomized open Clinical Trial to study the  safety and efficacy of Siddha trial drug Sooli kana nei  (internal) is to be given about 2-5grams twice a day for 14 days to 40 patients.Clinical Trial conducted after conducting Pre Clinical oral toxicity study.The trial drug Sooli kana nei has mentioned in Pillai pini Maruthuvam Part 2.During the trial study related data will be recorded and documented.After the completion of trial all data will be statistically analysed. 
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