A RANDOMIZED OPEN-LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF AMRUTHADI KASHAYA IN THE MANAGEMENT OF SHEETAPITTA WITH SPECIAL REFERENCE TO URTICARIA AND COMPARE WITH THE EFFICACY OF HARIDRAKHANDA
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To clinically evaluate the efficacy of Amruthadi kashaya in the management of Sheetapitta with special reference to Urticaria based on subjective and objective parameters in the Institutional clinical setup
Study Overview
Brief Summary
Urticaria is a skin condition marked by temporary dermal swelling and itching caused by increased capillary permeability. Globally affecting over 65 million people, it significantly reduces quality of life. While modern treatments rely on antihistamines, steroids, and biologics, these often carry risks of sedation, weight gain, or high costs.
In Ayurveda, this condition is identified as Sheetapitta, a Vata-dominant disorder affecting the Rasa and Rakta tissues. It manifests as painful, red, wasp-sting-like wheals, often triggered by cold exposure or improper diet. While not detailed as a primary disease in the major ancient texts like the Brihatrayee, it is extensively covered in later works like Madhava Nidana.
This study evaluates the efficacy of Amruthadi Kashaya, a decoction sourced from the Yogaratnakara, in relieving Sheetapitta symptoms. It uses Haridrakhanda from the Bhaishajya Ratnavali as a proven control drug to establish a comparative clinical baseline.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patients presenting with classical signs and symptoms of sheetapitta such as varatee dashta samsthana shotha,kandu and toda 2 Patients exhibits symptoms falling within mild to moderate range on the UAS urticaria scale.
- •3 Subjects willing to participate with written informed consent, which is conveyed in the language, which the subject can understand.
Exclusion Criteria
- •1.Pregnant or lactating women.
- •Presence of uncontrolled systemic disorders such as diabetic mellitus, hypertention, IHD that may interfere course of disease or treatment response.
- •Known hypersensitivity or allergy to ingredients of the intervention drug or formulation
- •Use of systemic antihistamines, corticosteroids, immunomodulators.
Outcomes
Primary Outcomes
To clinically evaluate the efficacy of Amruthadi kashaya in the management of Sheetapitta with special reference to Urticaria based on subjective and objective parameters in the Institutional clinical setup
Time Frame: 0th day -pre-test assessment with subjective and UAS scale | 31st day – post-test assessment with subjective and UAS scale | 46th day – as drug free follow-up assessment with subjective and UAS scale
Secondary Outcomes
- 1. To assess the quality of life of patients through General Health Questionnaire Scale.(2.To undertake the detailed literary review of Sheetapitta ,Amruthadi Kashaya)
Investigators
DR GAYATHRI KRISHNAKUMAR
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL