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
|
|
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
|
|
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. |