An Open-Label, Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial formulations– Qurs Asfar and Zimad e Bars in Qooba (Dermatophytosis)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Improvement in signs and symptoms of Qooba (Dermatophytosis) i.e. Annular/arcuate polycyclic lesion with clear centre, Papulo-vesiculation at margin, Scaling at margin, Erythema, Itching and Burning
研究概览
简要总结
This study is designed as a single centric open trial in patients with **Qooba (Dermatophytosis)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 06 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Qurs Asfar:
| S. No. |
Unani Name
Botanical name/ Chemical Composition
Weight
|1.
Gandhak (Saeeda)
Sulphur
100 g.
|2.
Soda Khurdani
Sodium carbonate
200 g.
|3.
Ararot Paste
Maranta arundinacea
120 g.
|4.
Sang Jarahat Saeeda
Hydrated Magnesium Silicate
2 g.
|5.
Magnesia Fahmi
Magnesium hydroxide
1 g.
|6.
Shamaeen
Liquid Paraffin
5 ml
Composition ofZimad e Bars:
| S. No. |
Unani Name
Botanical Name/ Chemical Composition
Weight
|1.
Bekh-e-Ajeer Dashti
Ficus carica
100 gm.
|2.
Babchi
Psoralea corylifolia
100 gm.
|3.
Tukhm-e-Panwar
Cassia tora Linn
100 gm
|4.
Narkachoor
Curcuma zedoaria
100 gm
|5.
Aab-e-Lemu
Citrus limon
Q.S.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group of 18-65 years.
- •Subjects confirmed by direct microscopy
- •Clinical signs and symptoms suggestive of fungal infection.
排除标准
- •Subjects on topical treatment within 2 weeks prior to entry into the study
- •Subjects on systemic therapy within 4 weeks prior to entry into the study
- •Subjects with Tinea capitis (tinea of scalp), Onychomycosis (tinea of nails) and Tinea barbae (tinea of beard)
- •Known cases of allergy to any ingredients of the study drug.
- •Subjects with history of diabetes mellitus and systemic illness requiring long-term treatment.
- •Lactating and pregnant women.
结局指标
主要结局
Improvement in signs and symptoms of Qooba (Dermatophytosis) i.e. Annular/arcuate polycyclic lesion with clear centre, Papulo-vesiculation at margin, Scaling at margin, Erythema, Itching and Burning
时间窗: At baseline, Day 14, 28 and 42.
次要结局
- Haematological and biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline and end of treatment i.e. day 42)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)