A Randomized Controlled Trial (RCT) to Evaluate Safety and Efficacy of Compound Unani Formulations Nuqooe Musaffi Orally and Marhame Surkh Topically in the Management of Taqashshur al Jild (Psoriasis).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1. Psoriasis Area Severity Index (PASI)
研究概览
简要总结
Taqashshur al Jild, Psoriasis is a chronic recurrent inflammatory skin disease characterized by sharply demarcated erythemato squamous plaques usually covered by silvery white scales. Common symptoms include itching and burning. Several clinical variants exist such as plaque type guttate erythrodermic inverse and pustular psoriasis. Globally the prevalence is between 2 and 3 while in India it ranges from 0.44 to 2.8 percent affecting males more frequently and typically appearing in the third or fourth decade of life. The etiology is multifactorial involving genetic immunological and environmental factors. Psoriasis is also associated with systemic conditions such as psoriatic arthritis metabolic and cardiovascular diseases and psychiatric disorders.
In Unani medicine psoriasis is known as Da us Sadaf or Taqashshur al Jild and is attributed to imbalances such as Ufoonate Rutoobat Hiddate Khoon and excessive heat in Safra and Sauda. The Unani treatment approach includes Tasfiyah e Dam blood purification Jali cleansing Tehleel e Auram anti inflammatory and Tarteeb moisturization therapies.
The present study aims to evaluate the safety and efficacy of two Unani formulations Nuqooe Musaffi oral and Marhame Surkh topical. After obtaining informed consent patients will be randomized into two groups. Group one Test group will receive Nuqooe Musaffi orally every morning and Marhame Surkh topically twice daily. Group two Control group will receive Betamethasone valerate 0.1 percent cream applied twice daily. Blood samples will be taken at baseline and at the final visit for pathological and biochemical analysis to assess clinical outcomes and treatment effectiveness.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically diagnosed cases of psoriasis.
- •Patients with PASI Score less than
- •Patients who are willing and able to comply with the protocol.
- •Patients who are willing and capable of providing a signed informed consent form.
排除标准
- •Pregnant and lactating women.
- •Patients of pustular psoriasis, erytherodermic psoriasis and psoriatic arthritis.
- •Patients with history of local and systemic corticosteroids, immunosuppressive drugs and anti psoriatic systemic therapies during last 4 weeks.
- •Patients with uncontrollable significant diseases like DM,Hypertension, renal failure, hepatic failure and cardiac comorbidities.
- •Patients suffering from other concomitant skin diseases like vitiligo,eczema, lichen simplex and seborrheic dermatitis etc.
- •Patients concurrently participating in any other clinical trial.
结局指标
主要结局
1. Psoriasis Area Severity Index (PASI)
时间窗: 1. Psoriasis Area Severity Index (PASI) at Baseline and Final visit | 2. Itching Visual Analogue Scale (VAS) at day 1,14,28,42
2. Itching Visual Analogue Scale (VAS)
时间窗: 1. Psoriasis Area Severity Index (PASI) at Baseline and Final visit | 2. Itching Visual Analogue Scale (VAS) at day 1,14,28,42
(On a 10 cm long horizontal scale)
时间窗: 1. Psoriasis Area Severity Index (PASI) at Baseline and Final visit | 2. Itching Visual Analogue Scale (VAS) at day 1,14,28,42
次要结局
- Dermatology Life Quality Index (DLQI)(On day 1,14,28,42)
研究者
Bushra Ansari
Hakim Syed Zia ul Hasan Government Autonomous Unani Medical College and Hospital
