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CTRI Number  CTRI/2019/12/022302 [Registered on: 11/12/2019] Trial Registered Prospectively
Last Modified On: 05/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of Aparajit Avaleha in treatment of Dry Cough 
Scientific Title of Study   A clinical study to evaluate the efficacy of Aparajit Avaleha in the management of Vataja Kasa 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  Dr Anshul Baloda  
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  1st Floor Room No-204,Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9992628646  
Fax    
Email  balodaanshul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aboli Patil 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurved 
Address  1st Floor Room No-204,Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7498549893  
Fax    
Email  drabolipatil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aboli Patil 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurved 
Address  1st Floor Room No-204,Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7498549893  
Fax    
Email  drabolipatil@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara  
 
Primary Sponsor  
Name  Department of Kaumarbhritya 
Address  Parul Institute of Ayurved, Parul University, post Limda, tal Waghodia, Vadodara 
Type of Sponsor  Private 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 Anshul Baloda  Parul Ayurved Hospital  OPD No 112, Department of Kaumarbhritya, Parul Ayurved Hospital, Parul University, Post limda, Tal Waghodia,Vadodara
Vadodara
GUJARAT 
9992628646

balodaanshul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aparajit Avaleha  Aparajit Avaleha DOSE (6-9 years) 20gm divided in three dose after food for 14 days. DOSE (9-12 years) 30gm divided in three dose after food for 14 days Route of Administration -ORAL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patients of Vataja Kasa with symptoms Parshavshool, Shirashool, Urashool, Sawarbheda, Shuska Mukha and Gala as a major symptoms.
2.Acute Cough of less than 7 days.
3.Newly diagnosed cases of Vataja Kasa. 
 
ExclusionCriteria 
Details  1.Patients below age of 6 years and above age of 12 years.
2.Patients with chronic debilitating disease or disorders.
3.All types of Kasa except Vataja Kasa Lakshana will be excluded.
4.Conditions like Pneumonia, Juvenile Diabetes Mellitus, Tuberculosis, Bronchiolitis, Asthma< Chronic Productive Cough, Whooping Cough, Sinusitis, Tonsillitis should be excluded.
Cough with High Grade Fever.
5.If Cough aggravates during treatment then it will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A beneficial effect of Aparajit Avaleha in the management of Vataja Kasa in children  21 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the mode of action of Aparajita Avaleha in management of Vataja Kasa  21 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2019 
Date of Study Completion (India) 02/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
Nowadays Kasa is considered asa a symptom for any underlying disease process and symptomatic treatment is advised in the form of expectorant or cough suppressant according to the nature of Cough.
For Dry Cough which is correlated with Vataja Kasa, cough suppressant such as Codeine, Dextromethorphan, Chlorpheniramine maleate etc are generally used which causes various side effects such ads CNS depressant, tremors, drowsiness in the school and finally school absentism etc and at the same time affects the growth and development of the child.
In Ayurveda, there are many compound drugs explained to treat Vataja Kasa, which are safe and effective and also useful to prevent the recurrence of respiratory illness and promoting the growth of children at the same time.
So, Ayurveda herbal combination Aparajit Avaleha is taken mentioned in Chakraduta as trail drug in this study.   
Contents of Aparajit Avaleha can be very effective for the management of Kasa as a compared to the contemporary medicines.
So, here is a sincere effort to find out the alternative and cost effective treatment for Vataja Kasa with the help of Aparajit Avaleha.
 
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