Clinical validation of Unani pharmacopeial formulation Habb-e-Mujarrib in Shaqeeqa (Migraine)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- The efficacy of the study drug will be assessed on the basis of clinical parameters based on grading of symptoms, scoring of MIDAS and any change in rescue medication pattern.
研究概览
简要总结
This study is designed as a multi centric open trial in patients with Shaqeeqa (Migraine). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every 2 weeks for 12 weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of****Habb-e-Mujarrib:
| S. No. |
Ingredients
Botanical Name
Quantity
|1.
Sibr
Aloe barbadensis miller
1 g
|2.
Chiraita sheeren
Swertia chirata
2 g
|3.
Jauzbuba
Myristica fragrans
2 g
|4.
Zeera safed
Cuminum cyminum
3 g
|5.
Tukhm e karafs
Apium graveolens L
3 g
|6.
Aab e kundush
Centipeda minima
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 gender in the age group 18- 65 years
- •Primary diagnosis of Migraine without aura by ICHD-3 beta as follows: A.
- •At least five attacks fulfilling criteria B–D.
- •Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated).
- •Headache has at least two of the following four characteristics: Unilateral location Pulsating quality Moderate or severe pain intensity Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs).
- •During headache at least one of the following: Nausea and/or vomiting.
- •Photophobia and phono phobia.
- •Not better accounted for by another ICHD-3 diagnosis.
排除标准
- •Known case of any structural brain abnormalities
- •Known case of Ocular disease
- •History of Ischemic stroke
- •Any disease involving sinus e.g. Rhinosinusitis
- •Systemic illness requiring long term treatment
- •Known cases of Chronic kidney & liver disease
- •Known cases of Psychiatric illness
- •Difficulty distinguishing migraine headache from other headaches
- •Known cases of Epilepsy and other neurological disorders
- •History of alcohol and drug abuse.
- •Pregnancy & lactation.
结局指标
主要结局
The efficacy of the study drug will be assessed on the basis of clinical parameters based on grading of symptoms, scoring of MIDAS and any change in rescue medication pattern.
时间窗: At baseline and at every two weeks till the completion of the trial i.e. upto 12 weeks
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination(At baseline and at the end of treatment i.e. 12 weeks)