A Clinical studty to evaluate the Role of Virechanottara Udwartana in Sheetapitta with special reference to Chronic Urticaria
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Average change from baseline in following parameters: 1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals.
Study Overview
Brief Summary
Chronic Urticaria (CU) is a common dermatological condition affecting an estimated 15-20% of the general population at least once during the life time. Urticaria causes inconvenience in family structures, compromising performance at work, school, and negatively impacting on leisure activities.
Urticaria is a mast-cell-driven disease. Histamine and other mediators, such as platelet-activating factor (PAF) and cytokines released from activated mast cells, result in sensory nerve activation, vasodilatation, and plasma extravasations as well as cell recruitment urticarial lesions.
Contemporary modern medicine does not have complete cure for Urticaria. Modern second-generation antihistamines are considered as the first-line symptomatic treatment for urticaria and these medicines have undesirable side effects such as drowsiness, dry mouth, weight gain and increased resistance to infections.
The symptoms of urticaria is comparable to sheetapitta. The main focus of the present therapies aimed at symptomatic relief. Panchakarma therapies helps in cleansing the body and also helps in detoxification. The hyper immune response is seen in urticaria is countered effectively with panchakarma therapies. Virechana karma is one among the panchakarma therapy. Virechana Karma is a simple method of shodhana therapy which acts on sleshmasamsrusta pittaja vyadhi. After samshodhana, udwarthana can be used to ensure better results in sheethapitta vis-a vis Urticaria.
This study is designed as single arm study in patients with Virechanottara Udwarthana. After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on baseline, 10th and 50th day of treatment. This includes subjective assessment of general wellbeing, weekly UAS7 scores and physical examination. The total duration of treatment will be 50 days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 16.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Urticaria more than 6 weeks.
- •2 Patients fit for Purgation therapy vis a vis Virechana karma.
Exclusion Criteria
- •1 Urticaria less than 6 weeks duration 2 Patients suffering with other skin diseases such as Eczema, Psoriasis 3 Patient unfit for Purgation therapy vis a vis Virechana karma 4 Tuberculosis, HIV, HbsAg 5 Major systemic disorders, un controlled Diabetes 6 Patients suffering with Severe form of Angioedema 7 Drug induced Urticaria.
Outcomes
Primary Outcomes
Average change from baseline in following parameters: 1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals.
Time Frame: Assessment done on base line visit (day 0), and after 4 weeks of treatment
Secondary Outcomes
- To Improve the quality of life(Assessment done on base line and after8 weeks of treatment)