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临床试验/CTRI/2025/07/090450
CTRI/2025/07/090450尚未招募2 期

Clinical Study to evaluate the efficacy and safety of Habb e Mujarrab in the management of Shaqiqa (Migraine)

State Takmeel ut tib college and hospital near ramabai railly sthal lucknow1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年7月30日最近更新:

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:

  1. Assess efficacy of Habb-e-Mujarrab (1 gm BD, oral) for Shaqiqa.

  2. 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

发起方
State Takmeel ut tib college and hospital near ramabai railly sthal lucknow
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

ABDUL AZIZ

State Takmeel ut tib college and hospital

研究点 (1)

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