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CTRI Number  CTRI/2019/03/018242 [Registered on: 25/03/2019] Trial Registered Prospectively
Last Modified On: 31/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Pratishyaya(Recurrent rhinitis) in children by Ayurve 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY OF SHRUNGYADI CHURNA & BALCHATURBHADRADI YOGA IN THE MANAGEMENT OF PRATISHYAYA IN CHILDREN 
Trial Acronym  CSSHBYIMOPCH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BHUMI MORI 
Designation  MD Kaumarbhritya 
Affiliation  IPGT RA Jamnagar 
Address  IPGT and RA Gujrat ayurved university

Jamnagar
GUJARAT
361008
India 
Phone  9714713792  
Fax    
Email  bhumori.bm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof K S Patel 
Designation  Professor and HOD and RA Jamnaar 
Affiliation  IPGT RA Jamnagar 
Address  IPGT and RA Gujrat ayurved university

Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr V K Kori 
Designation  Associate Professor 
Affiliation  IPGT RA Jamnagar 
Address  IPGT and RA Gujrat ayurved university

Jamnagar
GUJARAT
361008
India 
Phone  9409207485  
Fax    
Email  drvkkori@yahoo.co.in  
 
Source of Monetary or Material Support  
IPGT and RA Jamnagar 
 
Primary Sponsor  
Name  Director IPGT and RA 
Address  IPGT and RA GAU JAMNAGAR 
Type of Sponsor  Research institution and hospital 
 
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 
Bhumi Mori  PG HOSPITAL IPGT and RA JAMNAGAR  Kaumarbhritya department
Jamnagar
GUJARAT 
9714713792

bhumori.bm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved university Jamnagar 361008 PGT/7/-A/Ethics/2018-19/3059   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Shrungyadi Churna  Shrungyadi Churna will be given in Pratishyaya of Children Duration of treatment 12 weeks Follow up 8 weeks Microbiological study of nasal swab will be done before and After treatment 
Comparator Agent  Group B Balchaturbhadradi Yoga  Balchaturbhadradi Yoga will be given in Pratishyaya of Children Duration of treatment 12 weeks Follow up 8 weeks Microbiological study of nasal swab will be done before and After treatment 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patient presenting with the classical symptoms of Pratishyaya like Nasa Srava, Peenasa, Kshavathu, Kasa, Shirogaurava.
Patient presenting with recurrence of at list 1 episode in a month or 6 episodes in a year.
 
 
ExclusionCriteria 
Details  Patients with congenital and anatomical deformities like DNS, nasal polyp etc
Patient presenting with symptoms of LRTI like Bronchial asthma, Pneumonia, Emphysema
Patient associated with systemic illness such as TB, HIV, and other chronic debilitating diseases and immune-compromised children
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To cure Pratishyaya in children by Ayurveda 2 To prevent recurrent attack of pratishyaya 3 increase immuniy   5 months 
 
Secondary Outcome  
Outcome  TimePoints 
Establish commonest etiopathological factor in pratishyaya with the help of microbiological study  5 Months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   29/04/2019 
Date of Study Completion (India) 21/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1.Pharmacognostical and Pharma ceutical analysis of herbal compound drug shrungyadi churna published in International Journal of Multidisciplinary Educational Research ISSN 2277-7881 volume 10 issue 2(4) february 2021. 2.Pharmaceutical and Pharmacognostical analysis of Balchaturbhadradi Yoga an effective herbal compound for Pratishaya in Children., European journal of biomedical and pharmaceutical sciences. ISSN 2349-8870 volume 7 issue 9 july 2020  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Present trial was open labeled randomized comparative clinical trial on Pratishyaya in children of either sex between 3 to 12 years of age. There were two Groups, Group A had treated with Shrungyadi Churna and Group B had treated with Balachaturbhadradi yoga with honey anupana ushnodaka. duration of treatment was 12 week and follow up 8 weeks. Pharmaceutical and pharmacognostical study of both drugs has been done. The assessment has been done on changes in sign and symptoms, general health condition, complete cure of disease and no recurrent episodes.  Total 101 patients registered in the study out of those 73 patients completed the treatments and 28 patients were discunitued from the study for various reasons.  Maximum number of the patients i.e. 62.37% came under the age group of 3 to 6 years. Majority of the patients were male i.e. 70.29%. In group A (Shrungyadi Churna) 33(92.5%) patients was complete cured , Mark improvement was found in 6 (15%) patients and moderate improvement was found in 1 (2.5%) patients respectively. While in Group B ( Balchaturbhadradi Yoga) 31(93.93%) patients complete cured, Mark improvement was found in 1 (3.03%) patients and Moderate improvement was found in 1 (3.03%) patients respectively. Although Balchaturbhadradi Yoga shown good antitussive activity due to Vamchalochana, Haridra and Shunthi, simultaneousely. Symptom relief was found immediate in compare to Shrungyadi Churna rasayana effect of both drugs nourishes to Pranavaha shrotasa. Shrungyadi chunra gives a better effect in Hematological parameteres on Hb & AEC it may be inferred that drug is efective in allergic conditions. In subsidence of the clinical sign and symptopms, Balchaturbhadradi Yoga relief faster but Shrungyadi churna is effective on symptom of Pratishyaya with better effect on Agnibala and Aturabala. Long duration of treatment also play an important role in correction of dietary habits & restrictions of Nidana. It play key role to make as routine. Microbial study of nasal mucosa and throat swab by smear and culture study fungal and bacterial  contminations were found in very less number of patients but bacterial contamination was more than fungal culture. Dispite the fact that no etiopathological component of pratishyaya, both contaminations were clered by ayurvedic treatment. Most of the parameteres highly significant results were in both groups but Group B (Balchaturbhadradi Yoga ) is showing marginally better results than Group A (Shrungyadi Churna) which justifies its traditiona use in different pediatric condition.


 
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