CTRI Number |
CTRI/2025/04/085586 [Registered on: 24/04/2025] Trial Registered Prospectively |
Last Modified On: |
24/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To study the effect of Vyoshadi Churna in children having cold. |
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the efficacy of Vyoshadi churna 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 |
Dr Bhagyashri Subhash Shinde |
Designation |
PG Scholar |
Affiliation |
Yashwant Ayurved College Post Graduate Training and Research Center Kodoli |
Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur MAHARASHTRA 416114 India |
Phone |
7038868544 |
Fax |
|
Email |
bhartishinde13.bs@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shailesh Raghunath Rajgolkar |
Designation |
Associate Professor |
Affiliation |
Yashwant Ayurved College Post Graduate Training and Research Center Kodoli |
Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur MAHARASHTRA 416114 India |
Phone |
8308410222 |
Fax |
|
Email |
shaileshrajgolkar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Bhagyashri Subhash Shinde |
Designation |
PG Scholar |
Affiliation |
Yashwant Ayurved College Post Graduate Training and Research Center Kodoli |
Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur MAHARASHTRA 416114 India |
Phone |
7038868544 |
Fax |
|
Email |
bhartishinde13.bs@gmail.com |
|
Source of Monetary or Material Support
|
Yashwant Ayurved College Post Graduate Training and Research Center Kodoli |
|
Primary Sponsor
|
Name |
Dr Bhagyashri Subhash Shinde |
Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India |
Type of Sponsor |
Other [Self] |
|
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 Bhagyashri Subhash Shinde |
Yashwant Dharmartha Rugnalaya |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India Kolhapur MAHARASHTRA |
7038868544
bhartishinde13.bs@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee Yashwant Ayurved College Post Graduate Training and Research Center Kodoli |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Churna , Reference: Shree Chakrapanidatta virachit Chakradatta savimarsha vaidyaprabha Hindi Vyakhyopet Dr. Indradev Tripathi, Chaukhamba Sanskrit Bhavan Waranasi.Adhyay 58 shloka 2-3,page no.343, Route: Oral, Dosage Form: Churna/ Powder, Dose: 370(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Puran guda), Additional Information: -Dose as per age | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudaharitaki Churna, Reference: Vridda jivika Kashyapa Samhita with Vidyotini hindi commentary by Srisatyapala Bhisagacharya, Chaukamba sanskrit samsthan, Varanasi, Pratishyaya Adhyaya., Route: Oral, Dosage Form: Churna/ Powder, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Dose as per age |
|
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
Patients with presenting symptoms of Pratishyaya as described in classical text.
Childrens of age group of 6 to 12 years.
Both gender irrespective of religion and socio-economic status. |
|
ExclusionCriteria |
Details |
K/C/O Chronic debilitating disease or disorders and congenital anamolies related to respiratory system.
Pratishyaya with lower respiratory tract infection.
Raktaj and Dushta Pratishyaya.
Duration of symptoms more than 1 week.
Children having fever more than 100 Celsius. |
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduced nasatrava,nasarodha,kshavathu |
7days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the effect of Vyoshadi Churna in Pratishyaya.
To assess improvement in Pratishyaya by signs,symptoms and gradation of assessment criteria.
To study etiopathogenesis of Pratishyaya in children.
To achieve outcome of study in 7 days. |
7 days |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 3 |
Date of First Enrollment (India)
|
05/05/2025 |
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
|
Randomised open controlled clinical trial to evaluate the efficacy of Vyoshadi Churna in Pratishyaya of children in age group 6-12 years. The assessment of signs and symptoms will be done at regular follows ups. Observation will be done from outcomes achieved in 7 days.
|