Clinical Validation of Unani Pharmacopoeial Formulation SharbatKhaksi in Humma (Fever)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Improvement in sign and symptoms of Humma (Fever)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Humma (Fever) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline and of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one day. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of SharbatKhaksi
| S. No. |
Ingredients
Scientific Name
Quantity
|1.
Badyan
Foeniculum vulgare Mill.
1.1 gm
|2.
Barg Gaozuban
Borago officinalis Linn.
0.66 gm
|3.
Khaksi
Sisymbrium irio Linn.
1.1 gm
|4.
Unnab
Ziziphus jujube Mill.
1.1 gm
|5.
Shakar Safaid
Saccharum officinarum Linn*.* (Sugar)
16.5 gm
|6.
Shahdeen
Honey
4.4 gm
|7.
Sat Limun
Citric Acid
0.044 gm
|8.
Natroon Punjabi
Sodium carbonate
0.022 gm
|9.
Methyle Paraben
Q. S.
|10.
Propyl Paraben
Q. S.
|11.
Sodium Benzoate
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
- •Â· Patients of either sex in the age group of 18-65 years · Patients having fever ≥100°F with or without any of the following symptoms Sweating Nausea Malaise Decreased appetite General weakness Headache Myalgia Loss of appetite Larza (shivering) Irritability.
排除标准
- •The following patients will be excluded from the study:
- •Age below 18 and more than 65
- •Weak debilitating patients
- •Pregnancy and lactation
- •Known hypersensitivity to study drug or any of its ingredients.
结局指标
主要结局
Improvement in sign and symptoms of Humma (Fever)
时间窗: one day
次要结局
- Haematological and biochemical assessment for safety assessment(at baseline and at the 2nd day)