| CTRI Number |
CTRI/2022/01/039120 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
03/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of shrungyadi churna in the management of kaphaj kasa in children |
|
Scientific Title of Study
|
Open randomised controlled clinical study on efficacy of shrungyadi churna in the management of kaphaj 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 |
Anjali AnilTekale |
| Designation |
PG Scholar kaumarbhritya |
| Affiliation |
Hon shri Annasaheb dange Ayurved medical college and post graduate and research center, Ashta |
| Address |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved
medical college and post graduate and research Center, Ashta
Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9356464503 |
| Fax |
|
| Email |
dranjalitekale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Dinesh Kamat |
| Designation |
Guide and HOD |
| Affiliation |
Hon shri Annasaheb Dange Ayurved medical college and post graduate and research Center, Ashta |
| Address |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved
medical college and post graduate and research Center, Ashta
Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9356464503 |
| Fax |
|
| Email |
anjudkamat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Anil Tekale |
| Designation |
PG Scholar kaumarbhritya |
| Affiliation |
Hon shri Annasaheb dange Ayurved medical college and post graduate and research center, Ashta |
| Address |
Department of kaumaryabritya Hon shri Annasaheb Dange Ayurved
medical college and post graduate and research Center, Ashta
Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9356464503 |
| Fax |
|
| Email |
dranjalitekale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon. Annasaheb Dange Ayurved Medical College and PG research center, Ashta |
|
|
Primary Sponsor
|
| Name |
Hon shri Annasaheb Dange Ayurved medical college and post graduate and research center Ashta |
| Address |
Hon shri Annasaheb Dange Ayurved medical college and post
graduate and research center 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 |
| Anjali Anil Tekale |
Hon. Annasaheb Dange Ayurved Medical College and PG research center, Ashta |
Department of Kaumarbhritya, Hon. Annasaheb Dange Ayurved Medical College and PG research center, Ashta Maharashtra
Sangli
MAHARASHTRA |
9356464503
dranjalitekale@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: Kaphaj kasa , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shrungyadi churn, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sitopaladi churna, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, 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)Patients having classical signs and symptoms of kaphaj kasa
2)Age group 6 year to 10 year.
|
|
| ExclusionCriteria |
| Details |
1)Kasa other than kaphaj kasa.
2) Kaphaj kasa associated with jwara.
3) Patient with conditions like pneumonia, HIV,TB , Bronchial Asthma, Juvenile diabetes mellitus will be excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine efficacy of shrungyadi churna on kaphaj kasa. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review literature of kaphaj kasa |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I Anjali Anil Tekale PG scholar Kaumarbhritya department trying to evaluate the efficacy of shrungyadi churna in the management of kaphaj kasa. During this trial I try to evaluate untoward effect of shrungyadi churna on kaphaj kasa. As there is no previous work done on shrungyadi churna , so emphasis will be made to find out easy , cost effective method to control kaphaj kasa. |