Clinical study on the efficacy of Guduchi Ghrita as shamananga snehapana in the management of Ekakushta (Plaque Psoriasis): A controlled clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the clinical signs and Symptoms of Ekakushta based on
研究概览
简要总结
A controlled clinical study on the efficacy of Guduchi ghrita as shamananga snehapana in the management of Ekakushta (Plaque Psoriasis) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Ekakushta (Plaque Psoriasis) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group)15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Guduchi ghrita internally as shamananga snehapana in the dose of 30ml in the morning 20mins before breakfast followed by ushnajala pana along with Nalpamaradi taila as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Panchatiktaka guggulu ghrita internally as shamananga snehapana in the dose of 30ml in the morning 20mins before breakfast followed by ushnajala pana along with Nalpamaradi taila as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. The primary outcome measure will be significant improvement noticed in Psoriasis area and severity index score (PASI) of Psoriasis after 30 days. The secondary outcome measure will be improvement noticed in the quality of life of the patient through Dermatological quality of life questionnaire after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient of age group 18 to 60 years fulfilling diagnostic criteria.
- •2.Patients irrespective of gender ,religion, socioeconomic status, 3.Patients with clinical features of Ekakushta or Plaque psoriasis.
排除标准
- •1.Subjects those who are unfit for Snehapana.
- •2.Subjects with Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Psoriatic arthritis.
- •4.Pregnant and Lactating Women.
- •5.Subjects age below 18 and above 60 years.
- •6.Subjects with Psoriasis having secondary severe infections.
- •7.Subjects with other than Plaque psoriasis.
结局指标
主要结局
Reduction in the clinical signs and Symptoms of Ekakushta based on
时间窗: Oth day (Baseline),15th day,30th day and 45th day
1.Psoriasis area and Severity index score
时间窗: Oth day (Baseline),15th day,30th day and 45th day
次要结局
- Significant improvement noticed in the Quality of life of patient and reduction in signs and symptoms of Ekakushta based on Dermatological quality of life questionnaire(Baseline,15th day,30th day and 45th day)
研究者
Dr Pooja Prakash Chougala
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital ,Bangalore