Clinical Validation of Unani Pharmacopoeial Formulation ItrifalKishneezi in Nazla Muzmin (Chronic RhinoSinusitis)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Improvement in sign and symptoms of Nazla Muzmin (Chronic RhinoSinusitis)
研究概览
简要总结
This study is designed as 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 week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Itrifal Kishneezi
| S. No. |
Ingredients
Botanical / Scientific Name
Quantity
|1.
Post- Halela Zard
Terminalia chebula Retz
100gm
|2.
Post-Halela Kabli
Terminalia chebula Retz
100gm
|3.
Halela Siyah
Terminalia chebula Retz
100gm
|4.
Aamla
Emblica officinalis Gaertn
100gm
|5.
Post-e-Balela
Terminalia bellirica Roxb.
100gm
|6.
Kishneez Khushk
Coriandrum sativum Linn.
100gm
|7.
Asal / Qand Safaid
Honey / Sugar
1.8 kg
|8.
Raughan-e-Badam / Raughan-e-Zard
Almond oil / Purified Ghee
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex of age 18-65 years
- •Patients with Sino-Nasal Outcome Test (SNOT) > 7
- •Patients clinically diagnosed of sinusitis of duration > 12 weeks with radiological changes.
排除标准
- •Patients of sinusitis with epistaxis, hypertension shall be excluded from the study
- •Patient having any growth in the nose like nasal polyps etc.
- •Patients with co-morbidity requiring long term treatment.
- •Pregnant and lactating females.
结局指标
主要结局
Improvement in sign and symptoms of Nazla Muzmin (Chronic RhinoSinusitis)
时间窗: 04 Weeks
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)