Impact of comprehensive oral and topical intervention on MIDAS scores, frontalis muscle activity, and dependence on rescue medication in migraine patients without aura: a randomized placebo-controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary endpoints of the study will be to calculate and assess:
研究概览
简要总结
Migraine, a prevalent and debilitating neurological condition, significantly impairs quality of life and functional capacity. Current pharmacological treatments side effect profile underscore the need for novel therapeutic interventions that are both effective and better tolerated.
Cannabis (Vijaya extract) has been proposed as a potential therapeutic agent for migraine due to its analgesic, anti-inflammatory, and anti-emetic properties. Both oral and topical formulations of cannabis may offer a novel approach to managing migraine symptoms. The rationale for this study is based on the hypothesis that cannabis can effectively reduce migraine frequency, severity, and associated disability without the adverse effects commonly seen with conventional treatments.
This study aims to provide scientific evidence on the efficacy and safety of cannabis (Vijaya extract) in treating migraine without aura. By comparing the impact of oral, topical, combined and placebo formulations this research seeks to identify optimal therapeutic strategies that offer rapid and consistent relief, restore patient functionality, and minimize adverse effects. The outcomes could lead to the development of new, effective, and well-tolerated treatments for migraine, improving the quality of life for patients and reducing the burden on healthcare systems and burden of disease overall due to improved ability to work / increased workplace productivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants meeting all the following criteria will be eligible for the study:
- •Male and females, between 18 to 49 years of age (both inclusive);
- •Participants with a headache history for more than 1 year, 5 or more attacks of headache in 3 months;
- •Willingness to take the investigational product, following the dietary restrictions for the duration of the study;
- •Willing to complete the migraine diary.
排除标准
- •Participants meeting any of the following criteria will not be eligible for the study:
- •Participant with primary psychiatric disorders (schizophrenia, depression, anxiety, psychosis), major medical illness like renal, hepatic, neurological and cardiac diseases, pure menstrual migraine
- •Participants on Ayurveda or Yoga intervention for the past 6 months
- •Participants on conventional prophylactic treatment were excluded from the study
- •Known history of hypersensitivity to investigational product or its component
- •Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;
- •Any condition that in the opinion of the investigator does not justify the trial participant’s inclusion in the study.
结局指标
主要结局
The primary endpoints of the study will be to calculate and assess:
时间窗: 1. at screening, day 30, 60 and 90. | 2. at screening and day 90.
1. Changes in MIDAS (Migraine Disability Assessment) scale score using migraine diary
时间窗: 1. at screening, day 30, 60 and 90. | 2. at screening and day 90.
2. Changes in Human Plasma Calcitonin Gene Related Peptide (CGRP) levels
时间窗: 1. at screening, day 30, 60 and 90. | 2. at screening and day 90.
For 40 patients before and after treatment (10 subjects in each group)
时间窗: 1. at screening, day 30, 60 and 90. | 2. at screening and day 90.
次要结局
- The secondary endpoints of the study will be to assess: 1. Assessment of change in the requirement of rescue medication (Abortive migraine medications) 2. Changes in the number of headaches (No. of events) events and intensity (on 0-10 VAS) using migraine diary 3. Assessment of changes in Migraine Specific Quality of Life Questionnaire (MSQ) score
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital