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CTRI Number  CTRI/2019/05/019120 [Registered on: 14/05/2019] Trial Registered Prospectively
Last Modified On: 10/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on Kanduparangi Chooranam in the management of Iya Iraippu Noi (Bronchial Asthma) 
Scientific Title of Study   A Prospective Open-labelled, Non-Randomized, Phase -II Clinical trial of Kanduparangi Chooranam in the management of Iya Iraippu Noi (Bronchial Asthma) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C B S Bharath Christian 
Designation  PG Scholar  
Affiliation  Government Siddha Medical College and Hospital  
Address  II Year PG Scholar Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627 002
India 
Phone  8525883880  
Fax    
Email  cbssiddha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Manoharan MD Ph D  
Designation  Professor and HOD 
Affiliation  Government Siddha Medical College and Hospital  
Address  Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627 002
India 
Phone  9443886700  
Fax    
Email  drmanoharan25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SJustus Antony MD PhD 
Designation  Lecturer Grade II 
Affiliation  Government Siddha Medical College and Hospital  
Address  Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627 002
India 
Phone  9443090849  
Fax    
Email  justusantony71@gmail.com  
 
Source of Monetary or Material Support  
OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital Palyamkottai Tirunelveli - 627 002 Tamilnadu India 
 
Primary Sponsor  
Name  Government Siddha Medical College and Hospital  
Address  Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu 627 002 
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 
Bharath Christian C B S  Government Siddha Medical College   OPD Number 10 PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu 627 002
Tirunelveli
TAMIL NADU 		 8525883880

cbssiddha@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: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kanduparangi Chooranam  60 mg/Kg/BW/twice a day A/F 30 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient with the symptoms of dry cough, recurrent attacks of dyspnoea,hoarseness of voice,frequent hemming,tightness of chest, profuse sweating & wheezing
2)H/o allergens, sneezing.
3)Patients who are willing to take radiological investigation and provide blood for lab investigation.
4)Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using Mini-Peak flow meter and PEFR below normal range from 250L/min to 150 l/min for men, from 200L/min to 100 L/min for women, for those patients are included.
7)Patients who are willing to do Spirometer study - To estimate Pulmonary Function Test (PFT)
 
 
ExclusionCriteria 
Details  1)Pregancy
2)Lactating mother
3)Cardiac disease
4)Renal disease
5)Tuberculosis
6)Chronic bronchitis
7)Status asthmaticus
8)Diabetes mellitus
9)Auto immune disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
If during treatment or after treatment reduction of the following symptoms
1.Dry cough
2.Recurrent attacks of dyspnoea
3.Hoarseness of voice
4.Frequent hemming
5.Tightness of chest
6.Profuse sweating
7.Wheezing.
 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Evaluation of physicochemical, phyto chemical, bio chemical, pharmacological activities of “Kanduparangi Chooranam”.
2.Evaluation of siddha parameters (including Envagai thervu)changes in “IYA IRAIPPU NOI ” during trial period.
3.Evaluation of modern parametric changes in “IYA IRAIPPU NOI”.
4.Evaluation of safety profile for acute and sub-acute toxicity of trial drug.


 		 30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/05/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is a prospective open labelled phase II non-randomized clinical study to evaluate the therapeutic efficacy of Kanduparangi Chooranam in the management of Iya Iraippu Noi( Bronchial Asthma).The trial drug will be administered at the dose of 60 mg/ Kg /BW/Twice a day A/F 30 days along with honey as adjuvant in 60 patients (30 in OPD and 30 in IPD).The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelvelli Tamilnadu. The primary outcome will be evaluation of therapuetic efficacy of trial drug Kanduparangi Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug.In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patient will be given in OPD facility.  
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