Clinical Validation of Unani Pharmacopoeial Formulation Majoon Musaffi-Azam in Busoor (skin eruptions)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- The lesion will be evaluated according to its number, size, and associated symptoms. Grading on the basis of the number of lesions will be recorded.
研究概览
简要总结
This study is designed as a multi centric open trial in patients with **Busoor (skin eruptions)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Majoon-musaffi-e-Azam:
| S. No. |
Ingredients
Botanical Names
Quantity
|1
Barg-e-Shahtra
Fumaria officinalis Linn.
200gm.
|2
Post halela Zard
Terminalia chebula Retz. Yellow
160gm.
|3
Post halela Kabuli
Terminalia chebula Retz. Black
120gm.
|4
Post balela
Terminalia bellirica (Gaertn.) roxb.
400gm.
|5
Amala Khusk
Emblica officinalis Gaertn
400gm.
|6
Post halela siyah
Terminalia chebula Retz.
300gm.
|7
Barg-e-Sana
Cassia angustifolia Vahl
50gm.
|8
Gul-e-Surkh
Rosa indica L.
120gm.
|9
Maweez-e-Munaqqa
Vitis vinifera L.
1.5Kg.
|10
Bisfaij Fistaqi
Polypodium vulgare Linn.
130gm.
|11
Aftimoon
Cuscuta reflexa Roxb
130gm.
|12
Turbud
Operculina turpethum (Linn.)
130gm.
|13
Qand Safaid
Sugar
08Kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex
- •Patients in between age 12 to 60 Age Group
- •Frequently occurrence of Busoor, with or without association of following features.
- •Humra (Erythema).
- •Hikka (Itching).
排除标准
- •Patients of Busoor associated with fever.
- •Patients with other inflammatory and suppurated conditions of skin e.g. Abscess, Carbuncle, and Cellulitis.
- •Patients with features of Cellulitis
- •Patients with diabetes mellitus
- •Patients with disease required long term treatment e.g. Metabolic Disorders, specific infectious disease and cancer etc.
- •Pregnancy and lactation.
结局指标
主要结局
The lesion will be evaluated according to its number, size, and associated symptoms. Grading on the basis of the number of lesions will be recorded.
时间窗: At baseline, day 7, 14, 21 and at the end of treatment.
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline and after 4 weeks)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)