A Randomized Open Labelled Comparative Controlled Clinical Study to evaluate the efficacy of Dashmoola Avaleha and Shirish Avaleha in the Management of Vataja Pratishyaya (Allergic Rhinitis) in Children
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Institute for Ayurved Studies and Research
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Primary outcomes-
Overview
Brief Summary
Allergic Rhinitis (AR) is an inflammation of the nasal mucosa caused by an abnormal reactivity to an aeroallergen.Allergic rhinitis is a very common disorder that affects people of all ages, peaking in the teenage years. It is frequently ignored, under diagnosed, misdiagnosed, and mistreated, which not only is detrimental to health but also has societal costs. Allergic Rhinitis is an immunoglobulin E-mediated immunologic response of nasal mucosa to airborne allergens .Many treatment modalities are explained in Allopathic science like corticosteroids, anti-Allergic drugs, inhalers, antihistamines etc. but none of them are totally effective in curing the disease as well as preventing its recurrence, more over they have their own side effects like Rhinitis.So,this clinical trail has been designed to assess the efficacy of Dashmoola avaleha and shirish avaleha for oral administration in the management of Vataj pratishaya in children of age 6 year to 14 year is selected from O.P.D. of Kaumarbhritya Department of Institute for Ayurved Studies and Research.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Signs and Symptoms of Vataja Pratishyaya (as per Ayurvedic classics) and Allergic Rhinitis (as per Allopathic science).
- •2 Parents of children willing to participate in the study 3 Age group: Between 6 to 14 years, irrespective of sex, religion, or socioeconomic status 4 SFAR score greater than 7.
Exclusion Criteria
- •1 Patients with a history of bronchial asthma, tuberculosis, pleural effusion, emphysema, lung abscess, bronchiectasis, pneumonia, or pleurisy 2 Patients below 6 years of age or above 14 years of age 3 Patients presenting with complications of allergic rhinitis such as nasal polyps, tumor of the nose, or deviated nasal septum (DNS) 4 Patients with a history of nasal surgery.
Outcomes
Primary Outcomes
Primary outcomes-
Time Frame: 14 days
I. It will be accessed on the basis of statistical analysis applied on subjective parameters after
Time Frame: 14 days
completion of trial.
Time Frame: 14 days
Secondary Outcomes
- 1. Literary data related to Vataja Pratishyaya (Allergic rhinitis) will be compiled from different(texts of Ayurveda and modern part.)
Investigators
Dr Shruti Mehta
Institute for Ayurved Studies and Research