CTRI/2026/04/107515Not yet recruitingPhase 2
A Comparative Clinical Trial to evaluate the effectiveness of Patola triphaladi Kashaya in comparison to Amrtavrishadi Kashaya in Urticaria
Dr JEEVAN K G2 sites in 1 country122 target enrollmentStarted: April 15, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 122
- Locations
- 2
- Primary Endpoint
- Change in severity of urticaria symptoms (itching, wheals,rashes,dermatographism)using a predefined symptom grading scale
Study Overview
Brief Summary
Urticaria is a common dermatological condition characterized by wheals, itching, and erythema. This study aims to evaluate the effectiveness of Patola triphaladi Kashaya compared to Amrtavrishadi Kashaya in managing urticaria. A total of 122 participants will be randomized into two groups and treated for 45 days with a follow-up of 15 days. Outcomes will be assessed using symptom grading scale, Urticaria Activity Score (UAS7), and serum IgE levels
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with signs and symptoms of Urticaria Both male and female participants between the age group of 18-70 presenting with less than 50 wheals along with and symptoms such as itching, rashes, dermatographism.
Exclusion Criteria
- •Participants on continuous allopathic medications for urticaria Participants having history of anaphylaxis and urticarial vasculitis Participants having drug allergy Participants with uncontrolled systemic illness Patients not co-operating with the study Pregnant women and lactating mothers Others dermatological conditions like contact dermatitis, allergic eczema, angioedema.
Outcomes
Primary Outcomes
Change in severity of urticaria symptoms (itching, wheals,rashes,dermatographism)using a predefined symptom grading scale
Time Frame: from baseline to day 15, day 30, day 45 and day 60
Secondary Outcomes
- change in Urticaria Activity score(during baseline (Day 1-7), during treatment (Day 39 -45), and end of study (Day 53 -59))
- Change in serum IgE levels(from Baseline (Day 0) to day 60)
Investigators
Dr JEEVAN K G
Glocal College of Ayurvedic Medical Science and Research Centre
Study Sites (2)
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