CTRI/2021/09/037012尚未招募3 期
An Open-Label, Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial formulation – Habb-e-Karanjawa in Humma (Fever)
Central Council for Research in Unani Medicine CCRUM New Delhi1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年8月10日最近更新:
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 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 at every 3rd day. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Habb**e-Karanjawa
| S. No. |
Ingredients
Botanical / English Name
Quantity
|
Maghz-e-Karanjawa
Caesalpinia bonducella
One piece
|
Tutiya-e-Sabz Biryan
Green Vitriol (Ferrous Sulphate)
125 mg
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
- •Participants of either sex in the age group 18 to 60 years
- •History of onset of fever within 24 hr
- •Participants with oral temperature ≥100 0F presenting with any of the following symptoms: Body ache Headache Joints pain Shivering Chills Sweating Palpitation Skin Flushing.
排除标准
- •Intake of any antipyretic drugs in the previous 8 hrs.
- •Participant having oral temperature of ≥ 1040F
- •Known high risk clinical conditions such as pneumonia, sepsis, dengue haemorrhagic fever,meningitis, hepatitis B, etc.
- •Immuno-compromised clinical conditions such as HIV/AIDS, cancer, etc.
- •Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •Thrombocytopaenia defined as absolute platelet count below 50000/ cu.mm.
- •Pregnant and Lactating females.
结局指标
主要结局
Improvement in signs and symptoms of Humma (Fever)
时间窗: 1 week
次要结局
- Haematological and biochemical assessment for safety assessment(At baseline and after one week)
研究者
研究点 (1)
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