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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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
2Comparator ArmDrugClassical(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.

 
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