A Single Arm Open Label Clinical Study To Evalute The Efficacy Of Khadira-Triphaladi Kasaya Ghanvati And Aragvadha Cream With Mridu Virechan In The Management Of Psoriasis In Children.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Change in the scoring/grading of symptom of psoriasis in PASI scale
研究概览
简要总结
In this study 34 patients were enrolled, of whom 30 successfully completed the trial, while 4 participants discontinued during the study. The study population was recruited from the Outpatient Department (O.P.D.) of the Department of Balroga at the National Institute of Ayurveda. The diagnosis of study subjects was confirmed either through pre-existing clinical diagnoses of psoriasis or by screening individuals with clinical features of psoriasis using the PASI scale.Most patients belonged to the lower-middle socioeconomic class (44.12%) and practiced Hinduism (64.7%). Regarding personal habits, 85.3% had good appetite, 94.2% maintained proper sleep, and 61.8% had regular bowel movements. Dietary patterns showed a predominance of Madhura Rasa–dominant food (55.9%) and Viruddha Ahara consumption (73.5%), with 47.06% consuming fast food twice weekly. The majority of patients had Vata–Kapha prakriti (64.7%), 41.18% exhibited Tvaka Sara, 53.33% had Avara Sattva, 85.29% had Pravara Ahar Shakti, and 70.59% displayed Madhyama Jarana Shakti. Following therapy, the mean PASI score decreased from 17.33 to 4.27, the APso-PI score from 13.87 to 4.00, and the APso-PST score from 14.33 to 4.53. These changes were highly significant (P < 0.001), confirming the effectiveness of the intervention in alleviating the clinical manifestations of psoriasis and improving patients’ quality of life.
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
- 10.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children of either sex in between age group of 10 to 16 years.
- •2.Patients presenting with clinical features of psoriasis.
- •3.Mild to Moderate psoriasis in affected area according to PASI Scale (1-69%) 4.Patient should be capable of obeying the instruction related to course of therapy.
排除标准
- •1.Severe psoriasis in affected area according to PASI scale.
- •(more than 70%) 2.Known case of Acute/Chronic Eczema and Leprosy.
- •3.Development of any allergic or hypersensitive signs and symptoms during the trial period (due to trialdrug).
结局指标
主要结局
1.Change in the scoring/grading of symptom of psoriasis in PASI scale
时间窗: 4 MONTHS
次要结局
- 1.Change in the APso-QOL parameter(2.To evaluate the safety of trial drug (Khadira- Triphaladi Kasaya Ghanvati and Aragvadha Cream))
研究者
Dr Vishal N Prajapati
National Institute of Ayurveda Jaipur
