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临床试验/CTRI/2025/08/093854
CTRI/2025/08/093854尚未招募2 期

Therapeutic Evaluation Of Qatur Ravghane Banafsha And Tiryaq Isaba Wa Shaqiqa In The Management Of Migraine Without Aura Shaqiqa A Randomized Open Label Comparative Clinical Study

Hakim Syed Zia Ul Hasan Government Unani Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年9月8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
44
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

The term hemicrania refers to migraine, a primary headache disorder documented since ancient Mesopotamian times. Hippocrates first described it, and Galen provided further explanations regarding its location and cause. Migraine presents as recurrent pulsating headaches often with nausea, vomiting, light and sound sensitivity, and sometimes aura. It usually begins on one side of the head and varies in intensity, frequency, and duration. Globally, it is the third most common disease, affecting about 14.7 percent of people, more prevalent in women than men. The International Headache Society identifies two main types: migraine without aura (80–85 percent of cases) and migraine with aura (15–20 percent). While once thought to be purely vascular, current research links it to nerve and neurotransmitter involvement, including serotonin and CGRP. In Unani medicine, migraine is called Shaqiqa, from the Arabic word meaning half part. It is associated with nausea, vomiting, and unilateral head pain. The cause is considered an imbalance in temperament due to morbid matter, sometimes in the scalp muscles or meninges. Tabari noted the lack of morbid matter in scalp arteries prevents pain from spreading to the whole head. Some Unani physicians attribute it to thick fluids or vapors collecting in a weaker area of the head. Galen believed it indicated weakness on one side of the head. Unani classifies Shaqiqa into four types based on humors: Damawi (blood), Safrawi (bile), Balghami (phlegm), and Sawdawi (black bile), further grouped into hot and cold categories. Traditional Unani literature records many safe and effective remedies for Shaqiqa, and the present study aims to assess their efficacy and safety. Qutoor means drops instilled into the nose, ears, or eyes for therapeutic purposes.

For migraine (Shaqiqa), Qutoor with Roghan-e-Banafsha (oil of Viola odorata, sweet violet) is used as part of local therapy. Tiryaq Isaba wa Shaqiqa in the Unani System of Medicine is a classical compound formulation specifically designed for diseases of the nervous system, especially headaches and migraines (Shaqiqa).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients of 18 to 50 years of age Patients of all sexes Clinically diagnosed patients of Migraine without aura according to ICHD criteria Patients who will give consent and are able to do follow up.

排除标准

  • Patients below 18 and above 50 years of age Severe Anaemic patients Patients with known mental and psychiatric disorder Having systemic disorders Patients with a history of allergies especially to any component in the study drug Pregnant and lactating women Head injury Sinusitis Brain tumors.

结局指标

主要结局

Visual Analogue Scale

时间窗: On Day 0,7,14,21,28

次要结局

  • Migraine Specific Quality Of Life Questionnaire(On Day 0 and 28)

研究者

发起方
Hakim Syed Zia Ul Hasan Government Unani Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aarif Baig

Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital

研究点 (1)

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