Clinical Study to evaluate the efficacy and safety of Habb e Mujarrab in the management of Shaqiqa (Migraine)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Visual Analogue scale (VAS)
研究概览
简要总结
Clinical Study on Habb-e-Mujarrab for Shaqiqa (Migraine)
Background: Migraine, a neurovascular disorder with unilateral headaches, nausea, and sensory sensitivities, is linked to *sue mizaj maddi* in Unani medicine. Habb-e-Mujarrab, a polyherbal Unani formulation, is evaluated for its efficacy and safety in migraine management.
Objectives:
-
Assess efficacy of Habb-e-Mujarrab (1 gm BD, oral) for Shaqiqa.
-
Evaluate its safety.
Methodology:
Design Open-label, single-arm, pre-post interventional study.
Setting Moalajat OPD, State Takmeel-ut-Tib College, Lucknow.
Sample Size 38 patients (18–60 years), diagnosed per ICHD-3 criteria.
Exclusion Non-migrainous headaches, neuropsychiatric issues, pregnancy, systemic diseases.
Intervention Habb-e-Mujarrab (1 gm BD, oral) for 30 days, 60-day follow-up.
Composition Elwa, Chirata, Jaiphal, Zeera Safaid, Ajmod, Nakchikni.
Outcomes
Efficacy Visual Analogue Scale, Migraine Disability Assessment, rescue medication use.
Safety Adverse effects, haemogram, LFTs, KFTs, urine analysis, ECG.
Follow-Up Days 15, 30, 45, 60, 75, 90.
Study Duration**: 18 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with clinically diagnosed based on ICHD-3 diagnostic criteria for Migrainee A At least five Attack fulfilling criteria B-D B Headache attack lasting 4-72hr C Headache has at least two of the following four characteristic: Unilateral location pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs) D.
- •During headache, at least one of the following: Nausea and vomiting Photophobia and phonophobia E.
- •Exclusion of secondary cause of Headach
- •Patient willing to sign written informed consent.
排除标准
- •Participant below 18 years and above 60 years of age.
- •2 Non-migrationeous headache; cluster headache; chronic paroxysmal or nonparoxysmal hemicranias 3 Patient with neuropsychiatric illness.
- •4 Pregnancy and lactating women.
- •5 Patients with systemic illness and metabolic diseases
- •Patients unsure about attending treatment schedule regularly.
- •Patients with the history of trauma and accidents.
- •Familial hemiplegic migraine.
结局指标
主要结局
Visual Analogue scale (VAS)
时间窗: 15th, 30th, 45th, 60th, 75th 90th day
Migraine disability assessment (MIDAS)
时间窗: 15th, 30th, 45th, 60th, 75th 90th day
The number of rescue medication (e.g. simple analgesic, combination analgesics,
时间窗: 15th, 30th, 45th, 60th, 75th 90th day
ergotamine, triptans) taken within three months before and after the commencement of
时间窗: 15th, 30th, 45th, 60th, 75th 90th day
the treatment
时间窗: 15th, 30th, 45th, 60th, 75th 90th day
次要结局
未报告次要终点
研究者
ABDUL AZIZ
State Takmeel ut tib college and hospital
