| CTRI Number |
CTRI/2024/12/078025 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF VYAGHRYADI CHURNA IN KAPHAJ KASA IN CHILDREN |
|
Scientific Title of Study
|
OPEN RANDOMIZED CONTROL CLINICAL TRIAL OF VYAGHRYADI CHURNA IN THE TREATMENT OF KAPHAJ KASA IN CHILDREN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Chivhe |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9623025358 |
| Fax |
|
| Email |
chivheashishj96@gmail.comj |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh M Chaugule |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
4th Floor Department of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301
4th Floor Department of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921212722 |
| Fax |
|
| Email |
chaugulemahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh M Chaugule |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
4th Floor Department of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921212722 |
| Fax |
|
| Email |
chaugulemahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Chivhe |
| Address |
OPD No 5 Balrog OPD Dhanwantari Ayurved Hospital Ashta |
| 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 Ashish Chivhe |
Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta
Sangli
MAHARASHTRA |
9623025358
chivheashishj96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyaghryadi Churna, Reference: Nighantratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.6(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Katphaladi Churna, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.6(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient having classical signs and symptoms of kaphaj kasa since 3 days as explained in ayurvedic text
2)Patient will be selected irrespective of gender and socioeconomic class |
|
| ExclusionCriteria |
| Details |
1) Kasa other than Kaphaj Kasa
2) Kaphaj Kasa associated with Jwara
3) Patient with condition like Pneumonia TB Bronchial Asthma Interstitial Lung Disease
4)Patient with Congenital Abnormalities |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vyghryadi Churna is effective in the treatmennt of Kaphaj Kasa in Children |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Katphaladi Churna is effective in the management of Kaphaja Kasa in Children |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
06/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are many health problems in children one of them is Kasa Cough is the 5th most common symptoms for which patient requires medical care Cough should not be suppressed in younger children as retention of secretion can cause pulmonary complications I selected this topic for study because there was limited number of study done in previous work Vyaghryadi Churna which I have taken possesses kasaghna and kaphagna properties these drug will be taken in the form of churna whose formulation is easy to prepare |