CTRI/2015/03/005608招募中2 期
Clinical Validation of Unani Pharmacopoeial Formulation – Arq Ajeeb for symptomatic releif in SudÄ‘ (Headache)
Central Council for Research in Unani Medicine CCRUM New Delhi7 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2014年3月3日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 7
- 主要终点
- Improvement in signs and symptoms of Sudđ (Headache)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with **Arq Ajeeb in Sudđ (Headache)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on3rd and 7th day of treatment. 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 end of study.
Composition of Arq Ajeeb
| S. No. |
Unani Name
Botanical Name
Weight
|1.
Kafoor
Cinnamomum camphora
20 g
|2.
Jauhar-e- Pudina
Mentha arvensis
20 g
|3.
Jauhar-e- Ajwayin
Trachyspermum ammi
10 g
研究设计
- 研究类型
- Interventional
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 with age 18-65 years •Patients having SudÄ‘ (Headache) with or without any of the following symptoms: Disturbed concentration Irritability Zu‘f al-IshtihÄ’ (Decreased appetite) I‘yÄ (Fatigue) Difficulty in falling asleep and staying asleep Mild sensitivity to light/ noise.
排除标准
- •â€¢Headache does not respond to standard therapy •Headache accompanied by impaired neurological functions (loss of balance, weakness, numbness, or speech disturbances), double vision, seizures, mental disturbances, and loss of consciousness.
- •â€¢Headache accompanied by persistent nausea, vomiting, fever and stiff neck •History of recent head injury.
- •â€¢Known cases of any other acute illness.
- •â€¢Known cases of severe Renal/ Hepatic/ Cardiac ailments •Pregnant and lactating women.
结局指标
主要结局
Improvement in signs and symptoms of Sudđ (Headache)
时间窗: 7 days
次要结局
- Haematological and biochemical assessment for safety(7 days)
研究者
研究点 (7)
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