FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/06/034338 [Registered on: 22/06/2021] Trial Registered Prospectively
Last Modified On: 14/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   IT IS A COMPARATIVE CLINICAL STUDY TO ACCESS THE EFFECT OF VISHALADI CHURNA AND CHITRAKADI CHURNA IN CHILD HAVING COUGH WITH SPUTUM 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VISHALADI CHURNA AND CHITRAKADI CHURNA IN KAPHAJA KASA IN CHILDREN 
Trial Acronym  Interventional 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anu Shree 
Designation  PG Scholar MD Kaumarabhritya 
Affiliation  Alvas Ayurveda Medical College and Hospital Moodbidri 
Address  Department of PG studies in Kaumarabhritya Alvas Ayurveda Medical College and Hospital Moodbidri Dakshina Kannada District Karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9691453249  
Fax    
Email  anushree.shukla20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narayan Pai B 
Designation  Guide and Associate Professor Department of PG studies in Kaumarabhritya 
Affiliation  Alvas Ayurveda Medical College and Hospital Moodbidri 
Address  Department of PG studies in Kaumarabhritya Alvas Ayurveda Medical College and Hospital Moodbidri Dakshina Kannada District Karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9902329719  
Fax    
Email  drnarayanpai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anu Shree 
Designation  PG Scholar MD Kaumarabhritya 
Affiliation  Alvas Ayurveda Medical College and Hospital Moodbidri 
Address  Department of PG studies in Kaumarabhritya Alvas Ayurveda Medical College and Hospital Moodbidri Dakshina Kannada District Karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9691453249  
Fax    
Email  anushree.shukla20@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodbidri Dakshina Kannada District Karnataka 574227 
 
Primary Sponsor  
Name  Dr Ashish Tiwari 
Address  Dr Ashish Tiwari Shri Atharva Ayurveda Rasayanshala 541 Saket Nagar lalganj Raebareli UP 229206 
Type of Sponsor  Other [Husband] 
 
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 Anu Shree  Alvas Ayurveda Medical College Moodbidri  Kaumarabhritya OPD ground floor of Alvas Ayurveda Medical College and Hospital
Dakshina Kannada
KARNATAKA 		 9691453249

anushree.shukla20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethics Committee Alvas Ayurveda Medical College Vidyagiri Moodbidri India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J99||Respiratory disorders in diseasesclassified elsewhere. Ayurveda Condition: Kaphaja Kasa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chitrakadi Churna  Oral administration of Chitrakadi Churna to each patient of Kaphaja Kasa 8gms in 4 divided doses per day with Madhu after food for a period of 7 days. 
Intervention  Vishaladi Churna  Oral administration of Vishaladi Churna to each Patient of Kaphaja Kasa 8gms in 4 divided doses per day with Madhu after food for a period of 7 days. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients of either gender aged between 06 to 12 years
Patients with any of two or more symptoms described in the context of Kaphaja Kasa will be selected
Kaphaja Kasa of less than 15 days duration will be selected 
 
ExclusionCriteria 
Details  Kasa other than Kaphaja type are excluded
Kaphaja Kasa as anubandha lakshana and updrava in other systemic diseases
Patients below the age group of 06 years and above 12 years 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Kasa severity
Nishteevana
Throat Congestion
Aruchi
Peenasa
Gaurava 		 At baseline
7th day
10th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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/ Phase 3 
Date of First Enrollment (India)   22/06/2021 
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="3"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   It is a Comparative Clinical study to evaluate the efficacy of Vishaladi Churna and Chitrakadi Churna in Kaphaja Kasa in Children for  07 days in 40 patients will be conducted in Alvas Ayurveda Medical College and Hospital Moodbidri ,Vidyagiri ,Dakshina Kannada, India.
Primary outcome measure will be relief from Number of bouts of cough per hour, average duration of each bout of cough, disturbance in sleep, Aruchi, Gaurava, Throat congestion, Nishteevana Peenasa in 10 days.
 
Close