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Clinical Trials/CTRI/2019/03/018242
CTRI/2019/03/018242CompletedPhase 1

A COMPARATIVE CLINICAL STUDY OF SHRUNGYADI CHURNA & BALCHATURBHADRADI YOGA IN THE MANAGEMENT OF PRATISHYAYA IN CHILDREN

Director IPGT and RA1 site in 1 country100 target enrollmentStarted: April 29, 2019Last updated:

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
To cure Pratishyaya in children by Ayurveda 2 To prevent recurrent attack of pratishyaya 3 increase immuniy

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
3.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

To cure Pratishyaya in children by Ayurveda 2 To prevent recurrent attack of pratishyaya 3 increase immuniy

Time Frame: 5 months

Secondary Outcomes

  • Establish commonest etiopathological factor in pratishyaya with the help of microbiological study(5 Months)

Investigators

Sponsor
Director IPGT and RA
Sponsor Class
Research institution and hospital

Study Sites (1)

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