| CTRI Number |
CTRI/2024/12/078258 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the use of Gudapipali Yoga in Pratishayaya (Rhinitis )in children of age group of 6-12 years |
|
Scientific Title of Study
|
Randomised Open Controlled Clinical Trial To Evaluate the Efficacy of Gudapipali Yoga in Pratishyaya of Children in age group 6-12 years |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shradha Dattatray Admulwar |
| Designation |
Pg scholar |
| Affiliation |
Yashwant Ayurvedic College ,Kodoli |
| Address |
Opd no 7 ,Department of Balroga ,Yashwant Ayurvedic College and Research centre,Kodoli,Kolhapur
Maharashtra
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8208257831 |
| Fax |
|
| Email |
sdadmulwar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravatkumar Dash |
| Designation |
Md PhD Balroga |
| Affiliation |
Yashwant Ayurvedic College ,kodoli ,kolhapur |
| Address |
Opd no 7,Department of Balroga ,Yashwant Ayurvedic and Research center,Kodoli ,Kolhapur
Maharashtra
India
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravatkumar Dash |
| Designation |
Md PhD Balroga |
| Affiliation |
Yashwant Ayurvedic College ,kodoli ,kolhapur |
| Address |
Opd no 7 ,Department of Balroga ,Yashwant Ayurvedic College and Research center,Kodoli ,Kolhapur
Maharashtra
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no 7 ,Department of Balroga
Yashwant Ayurvedic College and Research center,Kodoli,Kolhapur,Maharashtra
416114
India
|
|
|
Primary Sponsor
|
| Name |
Shradha Dattatray Admulwar |
| Address |
Yashwant Ayurvedic College and Research center ,kodoli ,Kolhapur ,Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shradha Dattatray Admulwar |
Opd No 7 Balroga Department |
Yashwant Ayurvedic College and Research centre,kodoli,kolhapur
Maharashtra
India
Kolhapur
MAHARASHTRA |
8208257831
sdadmulwar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudapipali, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -(2) Medicine Name: GudaHaritaki, Reference: Kashyapa Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1350(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gudapipali, Reference: Yogaratnakar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting symptoms of Vataj,Pitaj,Khaphaj types of pratishyaya
Mentioned in ayurveda within 7 days.
Children off ahe group 6 to 12 years
Both gender irrespective of religion and socio economic status |
|
| ExclusionCriteria |
| Details |
Know case of Chronic debilitating disease or disorders like Cancer,Tuberculosis and Congenital Anomalies related to respiratory system
Duration of symptoms more than one week
Raktaj and Dushta Pratishyaya
Children having fever more than 100 celsius |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Efficacy of Gudapipali Yoga in Pratishyaya for children in age group of 6-12 years |
At 3 ,5 ,7 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the aetiology,pathology & clinical features in Pratishyaya |
At interval of 3 5 7 day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="91"
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 1 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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
|
To study the use of Gudapipali Yoga in Disease of Pratishyaya in the duration of 7 days and study for adverse effect of drug |