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
|
|
Primary Sponsor
|
Name |
Director IPGT and RA |
Address |
IPGT and RA GAU JAMNAGAR |
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 |
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
|
|
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. |