An Open-Label Randomized Controlled Clinical Study To Evaluate The Efficacy Of Khadirashtaka Kwatha In The Management Of Chronic Urticaria (Sheetapitta)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect of Khadirashtaka Kwatha on Chronic Urticaria ( Sheetapitta)
研究概览
简要总结
The study adopts an open-label randomized controlled design, enrolling diagnosed cases of chronic urticaria. Participants will be randomly assigned to two groups—one receiving Khadirashtaka Kwatha 48 ml after meals bd with lukewarm water for 4 weeks and the other receiving Tab Levocetirizine 5 mg at bed time once a day with water for 4 weeks. Clinical evaluation will be based on subjective parameters along with objective measures. The follow-up period will be 2 weeks.
This study seeks to scientifically validate the efficacy of Khadirashtaka Kwatha in managing Sheetapitta, correlating Ayurvedic principles with modern clinical parameters. If proven effective, this intervention could offer a holistic, safe, and sustainable approach to managing chronic urticaria, supporting the integration of Ayurvedic formulations into evidence-based clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have fulfilling Diagnostic criteria for Sheetapitta and the international guideline (EAACI/GA2LEN/EDF/WAO) for Chronic Urticaria.x
- •Patients who are willing and able to participate in the study and have Chronic Urticaria, defined as an urticarial eruption for more than 6 weeks duration.
- •Both male and female patients are between the age group of 20 – 60 years.
排除标准
- •Patients who are less than 20 years and more than 60 years in the age group.
- •The disease conditions and medication which will interfere the research output will be excluded.
- •Urticaria less than 6 weeks duration.
- •Drug induced Urticaria.
- •Pregnant and lactating women.
- •Patients with autoimmune diseases like Psoriasis, SLE.
- •Patients having angioedema.
结局指标
主要结局
Effect of Khadirashtaka Kwatha on Chronic Urticaria ( Sheetapitta)
时间窗: 1st, 2nd, 3rd and 4th week. Follow up on 5th and 6th week
次要结局
- To improve the Quality of life of the patient (QoL) of Chronic Urticaria (Sheetapitta)(1st week and 6th week)
研究者
Dr Disha Jayeshkumar Sakalshawala
G. J. Patel Institute Of Ayurvedic Studies And Research