A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Amrutharajanyadi Kashaya And Standard Care In Childhood Urticaria
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To study the effect of Amrutharajanyadi Kashaya on the clinical features,
Study Overview
Brief Summary
Urticaria is a dermal vascular reaction of the skin characterized by the appearance of itchy wheals, which are elevated (oedematous), pale or erythematous, transient and evanescent plaque lesions. The clinical picture of urticaria closely resemble with that of Sheetapitta described in Ayurveda classics. Sheetapitta is characterized by skin lesions which resembles Varathidamshta samsthana shotha (Appearance of swelling resembling as that of bite of wasp), Kandu(itching), Bahula Thoda (excessive pricking pain), Vidaha (burning sensation) associated with chardi (vomitting) and jwara(fever). Vata is predominant dosha in Sheetapitta. Although many cases of urticaria are self limiting, in case of chronic and recurrent conditions, parents generally sought treatment. To combat the hypersensitivity reaction in the body, administration of immunomodulatory drugs will be helpful especially in children who are having under developed immunity.
The selected trial drug, Amrutha Rajanyadi Kashaya contains drugs having proven immunomodulatory activity which will be helpful in managing the condition in children effectively. The primary objectives of the study are to study the effect of Amrutharajanyadi Kashaya and standard care in the management of childhood Urticaria separately and to to compare the effect in both the groups. The secondary objective is to evaluate and compare the effect of Amrutharajanyadi Kashaya and standard care on quality-of-life parameters in children suffering from Urticaria. The study hypothesize that Amrutharajanyadi Kashaya is as effective as standard care in managing childhood urticaria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged between 4 to 16 years of irrespective of gender, socioeconomic status.
- •Children showing classical clinical features of Sheetapitta and Udarda with mild fever (99.5F-100.5F) 3) Children showing features of Urticaria and dermographism.
Exclusion Criteria
- •Known case of any systemic disorders which interfere with the course of study.
- •Known history of anaphylaxis to any medicine.
- •Known history of severe cases of angioedema.
- •Other skin conditions with similar presentations like wasp bite.
Outcomes
Primary Outcomes
To study the effect of Amrutharajanyadi Kashaya on the clinical features,
Time Frame: Baseline | 15th and 28th day
number of reduction of episodes, time taken for reduction of rashes and the values of TC, DC, AEC and IGE
Time Frame: Baseline | 15th and 28th day
Secondary Outcomes
- To evaluate & compare the effect of Amrutharajanyadi Kashaya & standard care(on quality-of-life parameters in children suffering from Urticaria)
Investigators
Dr Pradeep N
JSS Ayurveda Medical College And Hospital
