Clinical Validation study on ŪnÄnÄ« Pharmacopoeial Formulation– Zimad e Bars in Kalaf (Melasma)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Improvement in signs and symptoms of Zimad e Bars in Kalaf (Melasma)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with **Zimad e Bars in Kalaf (Melasma)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline, 1st, 2nd, 3rd and 4th final follow ups. Each follow up will be carried out at the interval of two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be eight weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.
Composition of Zimaad e Baras:
| S. No. |
ŪnÄnÄ« Name
Botanical Name
Weight
|1.
Bekh-e-Anjeer Dashti
Ficus carica Linn.
100 g
|2.
Babchi
Psoralea corylifolia Linn.
100g
|3.
Tukhm-e-Panwar
Cleome icosandra Linn. Syn. C. viscosa Linn.
100g
|4.
Narkachoor
Zingiber zerumbet Rosc ex Smith
100g
|5
Aab-e-Lemu
Citrus limon (Linn.) Burm.f.
Q.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Subjects with 18 to 65 years of age The patient presenting anyone or all signs mentioned below.
- •Ill defined light brown to grey brown macules on Forehead
- •Ill defined light brown to grey brown macules in RMR
- •Ill defined light brown to grey brown macules on Chin.
排除标准
- •Patients with anyone of the following skin disease •Bahaq Aswad (pitryasis nigra) oNamash (Naevus).
- •oBarash (lentigo) oKhÄ«lÄn (mole) oNishanate Quruh oFitzpatrick skin type grade 1 & 2 •Any systemic disorder requiring long term treatment.
- •â€¢Drug or alcohol addict •Subjects with oral contraceptive pills (OCPs) •Pregnant and lactating woman •Those who refuse to avoid cosmetics during study period Subject Selection •Female subjects with 18 to 65 years of age •The patient presenting anyone or all signs mentioned below.
- •Ill defined light brown to grey brown macules on Forehead
- •Ill defined light brown to grey brown macules in RMR
- •Ill defined light brown to grey brown macules on Chin.
结局指标
主要结局
Improvement in signs and symptoms of Zimad e Bars in Kalaf (Melasma)
时间窗: 8 weeks
次要结局
- Haematological and biochemical assessment for safety assessment(8 weeks)