A Randomized Open Labelled Comparative Clinical Study To Evaluate The Efficacy Of Kushthaghana Mahakashaya And Khadir-Triphaladi Kashaya In The Management Of Ek-Kushtha With Special Reference To Plaque Psoriasis
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
- Improvement in subjective and objective parameters of Ek-Kushtha (Plaque Psoriasis):
研究概览
简要总结
The present study entitled “A Randomized Open-Labelled Comparative Clinical Study to Evaluate the Efficacy of Kushthaghana Mahakashaya and Khadira-Triphaladi Kashaya in the Management of Ek-Kushtha with Special Reference to Plaque Psoriasis” aims to assess and compare two classical Ayurvedic formulations for their efficacy in treating Ek-Kushtha (Plaque Psoriasis), a chronic immune-mediated skin disorder characterized by erythematous, scaly plaques. Thirty patients aged 16–60 years will be randomly divided into two groups: Group A will receive Kushthaghana Mahakashaya and Group B will receive Khadira-Triphaladi Kashaya, each administered in a dose of 48 ml twice daily before meals for 30 days. The study will follow an open-labelled, randomized, pre- and post-test comparative design over 18 months, with follow-ups on the 15th, 30th, and 45th days. Assessment will be based on both subjective (Matsyashakalopamam, Kandu, Rukshata) and objective (Auspitz’s sign, Candle grease sign) parameters. The primary outcome is the reduction in clinical signs and symptoms of Ek-Kushtha, and the secondary outcome includes improvement in quality of life and prevention of recurrence. The study aims to establish a safe, effective, and evidence-based Ayurvedic approach for the management of Plaque Psoriasis.
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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with classical features of Ek-Kushtha as per Ayurvedic texts and modern literature.
- •Patients aged between 16 and 60 years irrespective of gender.
- •Patients with a history of Ek-Kushtha less than two years.
排除标准
- •Age below 16 years and above 60 years.
- •Skin disorders other than Ek-Kushtha shall be excluded.
- •Patients with systemic disorders like cardiac illness, bronchial asthma, or endocrine disorders that may interfere with the treatment will be excluded.
- •Pregnant and lactating women.
- •Chronicity of disease for more than two years.
- •Patients who have undergone recent surgeries.
- •Patients on oral corticosteroid therapy.
结局指标
主要结局
Improvement in subjective and objective parameters of Ek-Kushtha (Plaque Psoriasis):
时间窗: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
Subjective: Matsyashakalopamam, Kandu, Rukshatva
时间窗: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
Objective: Auspitz’s Sign, Candle Grease Sign
时间窗: Assessment: Percentage relief in symptoms and signs after 30 days of treatment.
次要结局
- Improvement in quality of life and prevention of recurrence.
研究者
Dr Shubham Sharma
Jammu Institute Of Ayurveda And Research