A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of Safoof-i-Ushba and Roghan-i-Banafsha 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
- 60
- 试验地点
- 1
- 主要终点
- 1. Reduction in Psoriasis Area Severity Index (PASI)
研究概览
简要总结
Psoriasis is a papulo-squamous disorder of the skin characterized by sharply defined red scaly lesion. They vary in size from pin point to large plaques. It is universal in occurrence and the incidence is 1 to 3 % of the world’s population. A family history is found in 300% of the patient. Taqashshur al-Jild is also defined as a type ofskin disease characterized by roughening and hardening of affected part of skin accompanied with sloughing of fish like scales and itching. Unani system of medicine is based on Humoral concept. According to this concept: psoriasis is a melancholic disorder caused by derangement of Khilá¹-i Sawda (morbid black bile) resulting from Ḥiddat and TaÊ»affun-i Dam (impure blood). Taqashshur al-Jild (Psoriasis) is still incurable, Unani formulations, SafÅ«f-I Ushba possesses Muá¹£affÄ«-i Dam (blood purifier) and Munzij wa Mush’il-i Sawda (concoctive and purgative of melancholic humor) and removal of bad humors actions, and Rogan i-Banafsha possesses soothing
actions, resolvent, sedative effects. After completion of the study, data obtained will be analyzed statistically by using an appropriate t test to evaluate the significance of results. p<0.05 will be considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient clinically stable.
- •Patient with clinically diagnosed Taqashshur al-jild (psoriasis) of plaque type.
- •Psoriasis area severity index (PASI) ≥10%.
排除标准
- •Participants aged <18and >60years
- •Known cases of significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
- •Erythrodermic psoriasis.
- •Pregnancy and Lactation.
- •Patient not willing to attend treatment regularly.
结局指标
主要结局
1. Reduction in Psoriasis Area Severity Index (PASI)
时间窗: 12 weeks
2. Improvement in Investigators Global Assessment (IGA)
时间窗: 12 weeks
3. Improvement in Patient’s Global Assessment (PGA) on VAS
时间窗: 12 weeks
次要结局
- Systemic Safety Assessment(12 weeks)
