An open clinical Trial to evaluate the Effectiveness of Siddha formulation Oma Ilagam(Internal Medicine) and Kunthirika Thylam( External Medicine) in the management of Kaanakadi(Urticaria)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of the Trail Drug is measured using Urticaria Activity Score UAS
研究概览
简要总结
INTRODUCTION
Urticaria is characterized by itching wheal formation angioedema and pruritus which may be localized or generalized in the body recurrently for at least 6 weeks Although the wheals can resolve within 24 hrs symptoms have a significant detrimental impact on the quality of life of this patients Kaanakadi occurs when the body reacts to an allergen and releases histamine and other chemicals from under the surface of the skin Kaanakdi is a type of inflammatory disorder In the siddha text Aathma Ratchamirtham OMA ILAGAM has indicated for soolai sirangu kuttam kiranthi pun and silvisham The main ingretients of the above medicine are well known for its anti histamine anti inflammatory anti oxidant and anti immunomodulatory activities In the text book of Siddha Formulary of india 1 KUNTHIRIKA THYLAM has specifically indicated for skin disease
AIM
To evaluate the clinical effectiveness of siddha formulation OMA ILAGAM internal and KUNTHIRIKA THYLAM external in the management of KAANAKDI
OBJECTIVE
To assess the changes in clinical symptoms by using Urticaria Activity Score UAS
To assess the changes in clinical laboratory blood parameters such as IgE AEC CRP and ESR before and after treatment
STUDY TYPE
Interventional study
STUDY DESIGN
An Open Clinical Trial
OUTCOME OF STUDY
Clinical effectiveness of Oma ilagam and Kunthirika thylam in the management of urticaria will be evaluated by significant reduction in clinical symptoms based on Urticaria Activity Score and clinical laboratory blood parameters before and after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of erythematous wheal formation urticaria with UAS Score patients willing and able to to provide informed consent and to comply with the study protocol patients willing to stop using any treatment other than the investigational product for urticaria.
排除标准
- •Pregnant or lactation women Evidence of any skin condition other than urticaria Narcotic addicts and Angioneurotic oedema Other medications or disease that might directly interfere in the study.
结局指标
主要结局
Efficacy of the Trail Drug is measured using Urticaria Activity Score UAS
时间窗: Changes in the Urticaria Activity Score will be assessed before and after treatment along with blood parameters after 40 day of Trail Period
次要结局
未报告次要终点
研究者
Dr Dharmar M
National Institute of Siddha