A Single-blind, Randomized, Parallel group study to evaluate antipyretic effect of Unani Medicine formulation– Cap Mubarak compared to controlled drug Tab Paracetamol in patients with Humma (fever)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The efficacy of the study drug in the treatment of Humma (fever) will be assessed on the basis of reduction in the symptoms and change in temperature from baseline to end of the study and the achievement of defervescence,
研究概览
简要总结
This study is designed as a Single-Centric, Randomized, Single blind, Parallel Group Comparative Clinical trial in patients with Humma (Fever). Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients enrolled in the study will receive the medicine Cap Mubarak or Paracetamol as allocated by randomization method. The total duration of treatment will be 3 days and the follow-up for all clinical parameters will be conducted on baseline and at 3rd day.
Composition of Cap Mubarak
| S. No. |
Ingredients
Botanical / English Name
Quantity
|
Maghz-e-Karanjawa
Caesalpinia bonducella
2 parts
|
Zeera Safaid
Cuminum cyminum Linn.
|
Dar-e-Filfil
Piper longum Linn.
|
Barg-e-Babool
Acacia arabica Willd.
|
Kushta Goadanti
Calx Gypsum
1 part
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of either sex in the age group 18 to 65 years.
- •History of onset of fever within 24 hr.
- •Participants with oral temperature 100 F- 102 F presenting with any of the following symptoms: Fever Headache Body ache Joints pain Shivering Chills Palpitation Skin Flushing.
排除标准
- •Intake of any antipyretic drugs in the previous 8 hrs.
- •Participant having oral temperature of greater than 102 F.
- •Known high risk clinical conditions such as pneumonia, sepsis, dengue haemorrhagic fever,meningitis, hepatitis B, etc.
- •Known cases of Immuno-compromised clinical conditions such as HIV, 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.
- •Thrombocytopenia i.e. absolute platelet count below 1,00,
- •Known hypersensitivity to study drug or any of its ingredients.
- •Pregnant and Lactating females.
- •Diabetes Mellitus or any systemic disorder requiring prolonged treatment.
结局指标
主要结局
The efficacy of the study drug in the treatment of Humma (fever) will be assessed on the basis of reduction in the symptoms and change in temperature from baseline to end of the study and the achievement of defervescence,
时间窗: At baseline and on 3rd day
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline and end of treatment i.e. 3rd day.)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)