Clinical Validation of Unani Pharmacopoeal formulation Itrifal Zamani in Nazla Muzmin (Chronic Rhinosinusitis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- improvement in the sign and symptoms of Nazla Muzmin (Chronic Rhinosinusitis)
研究概览
简要总结
This study is a multicentric open trial in patients with Nazla Muzmin (Chronic Rhinosinusitis) 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 six weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Itrifal Zamani 16
| S. No. |
Ingredients
Quantity
|1
Post HalelaZard
50 g
|2
Post Halelakabuli
50 g
|3
HalelaSiyah
50 g
|4
Gul e Banafsha
50 g
|5
Saqmunia
50 g
|6
Turbud
100 g
|7
Kishneez
100 g
|8
Post Balela
25 g
|9
Amla
25 g
|10
Gul e Surkh
25 g
|11
Tabasheer
25 g
|12
Gul e Nilofer
25 g
|13
Sandal Safaid
15 g
|14
Kateera
15 g
|15
RoghanBadaam
120 g
|16
Unnab
150 g
|17
Sapistan
100 g
|18
SheeraMurabbaHaleela
1 Kg
|19
Asl or QandSafaid
1 Kg
|20
Gul e Banafsha
50 g
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of any in the age group of 18 to 60 years
- •Radiologically diagnosed Rhinosinusitis of more than12 weeks duration
- •SNOT Score > 11.
排除标准
- •Rhinosinusitis /Sinusitis of < 12 weeks
- •Deviated Nasal septum
- •Nasal polyps
- •Local pathology such as mucocele, cyst, antrochoanal polyp, facial trauma, radiation injury, or birth defect
- •Diabetes mellitus and any other illness requiring long term treatment
- •Pregnant and lactating women.
结局指标
主要结局
improvement in the sign and symptoms of Nazla Muzmin (Chronic Rhinosinusitis)
时间窗: six weeks
次要结局
- Hematological and biochemical assessments for safety(six weeks)