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CTRI Number  CTRI/2019/11/022196 [Registered on: 27/11/2019] Trial Registered Prospectively
Last Modified On: 27/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial to evaluate the efficacy of kana kudineer in children for Vali Kanam(Acute pharyngitis)  
Scientific Title of Study   Phase II an open single group non randomized study on valikanam (Acute pharyngitis) to evaluate the official Siddha formulation kana kudineer-In children of both sex aging between 3-12 years attending opd at Anna hospital  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalishwari B 
Designation  PG scholar  
Affiliation  Government Sidha Medical College 
Address  Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  7708824333  
Fax    
Email  drabibala8894@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rani V 
Designation  HOD and professor 
Affiliation  Government Siddha Medical College 
Address  Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  9442286863  
Fax    
Email  ranimoorthybsms19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalishwari B 
Designation  PG scholar 
Affiliation  Government Siddha Medical College 
Address  Post Graduate Department of Kuzhanthai Maruthuvam Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam

Chennai
TAMIL NADU
600106
India 
Phone  7708824333  
Fax    
Email  drabibala8894@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu 
 
Primary Sponsor  
Name  Government Siddha Medical College 
Address  Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu  
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 Kalishwari B  Aringar Anna Government Hospital Of Indian Medicine  Room no 25 Siddha Department 6 Anna arch road NSK Nagar Arumbakkam
Chennai
TAMIL NADU 
7708824333

drabibala8894@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: J02||Acute pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kana kudineer  15-30 ml Twice a day 14 days 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  3-12 years
Fever
Sore throat / throat pain
Hoarseness of voice
Cough
Pharyngeal Tendulkar erythema
Cervical adenopathy
Rhinitis 
 
ExclusionCriteria 
Details  Peritonsillar abscess
H/O Rheumatic fever
Diptheria
Inductive mononucleosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in center score
Reduction in clinical symptoms like fever, throat pain, sore throat and cough 
14 days 
 
Secondary Outcome  
Outcome  TimePoints 
It is assessed by comparing the safety parameters before and after treatment  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)   02/12/2019 
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)?  

Brief Summary   This is a single non randomized open clinical trial to study the safety and efficacy of Siddhartha trial drug kana kudineer. The trial drug is given 15-30ml twice a day for 14days. Clinical trial is conducted after conducting pretty clinical toxicity study. The trial drug kana kudineer is mentioned in pillai pini maruthuvam part  II. During the trial all the study relateddata will be recorded and documented. After the completion of trial all the data will be analysed statistically.  
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