Clinical Validation of Unani pharmacopoeial formulation Itrifal Ustukhudus in Nazla e Muzmin (Chronic Rhinosinusitis)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Reduction of SNOT-22 scores
研究概览
简要总结
This study is designed as a multicentric open trial in patients withNazla e Muzmin (Chronic Rhinosinusitis) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinicallyevery fifteen days. 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, first follow up and on completion ofthe protocol therapy.
Compositionof Itrifal ustukhudus15
| S. No. |
Ingredients
Botanical / Zoological Name
Quantity
|1.
Post-e-Halela zard
Terminalia chebula
100gm
|2.
Post –e-Halela Kabuli
Terminalia chebula
100gm
|3.
Halela Siyah
Terminalia chebula
100 gm
|4.
Post-e-Balela
Terminalia bellerica
100 gm
|5.
Aamla
Embilica officinalis
100 gm
|6.
Gul-e-surkh
Rosa damescera
100 gm
|7.
Ustukhudus
Lavendula stoechas
100 gm
|8.
Bisfayej
Polypodium vulgare
100 gm
|9.
Aftimoon
Cuscuta reflexa
100 gm
|10.
Kishmish
Vitis vinifera
100 gm
|11.
Roghan-e-zard
Clarified butter
20 gm
|12.
Qand safaid
Sugar
3kg
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
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of any in the age group of 19 to 60 years
- •Duration of disease >12 weeks 3.
排除标准
- •Rhinosinusitis /Sinusitis of < 12 weeks
- •Deviated Nasal septum 3.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
Reduction of SNOT-22 scores
时间窗: 6 weeks
Improvement in signs and symptoms of Zimad e Bars of Nazla e Muzmin (Chronic Rhinosinusitis)
时间窗: 6 weeks
次要结局
- Resolution of findings of X –ray PNS(at baseline and on completion of the protocol therapy ie after 6 weeks)