A Pilot Clinical Study to Evaluate the Safety and Efficacy of MIG-T, Vaidyaratnam’s Herbal Formulation, in the Management of Episodic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Background: Migraine is a neurological disorder characterized under ICHD-3 by recurrent unilateral headaches of moderate–severe intensity with nausea, vomiting, photophobia, or phonophobia, often triggered by psychological or physiological stress. Conventional prophylactic medications frequently show limited adherence, and medication overuse is common. In Ayurveda, the condition correlates with Ardhavabhedaka, a Shiroroga associated with Tridoshic imbalance and inflammatory involvement of Pitta–Rakta. Ayurvedic management focuses on doshic correction through classical therapies and internal formulations. MIG-T is a proprietary Ayurvedic polyherbal formulation developed by Vaidyaratnam, designed to support neurological stability and modulate inflammatory and stress-associated pathways. Preclinical assessments demonstrate safety compliance and suggest possible neuroprotective and anti-inflammatoryPurpose of the Study: This pilot clinical study aims to evaluate the safety, tolerability, and preliminary efficacy of MIG-T, a proprietary Ayurvedic formulation, in individuals with episodic migraine. MIG-T will be administered at a dose of 650 mg (two tablets) twice daily after food for 90 days to 20 eligible subjects. Outcomes will include improvement in MIDAS, HIT, PSIQ, VAS, monthly migraine days, migraine severity, rescue medication use, and quality of life assessed through MSQ scoring. Safety assessments and relevant laboratory investigations will be conducted throughout the study period to ensure tolerability and therapeutic safety.
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
- •1.Documented history of migraine-related headaches with or without aura on fewer than 15 days per month for more than one year.
- •2.Participants with the MIDAS score: Grade II: Ranging from 6-10 & Grade III: Ranging from 11-
- •Patients with a HIT-6 score greater than
- •4.Patients experiencing VAS score of 4–6 and PSQI score greater than
- •5.Migraine Days Per Month (MDPM): Fewer than 15 migraine days per month.
- •7.Ability to provide written informed consent and comply with study procedures.
排除标准
- •Chronic Migraine (CM): Headache occurrence of more than 15 days per month.
- •Patient with the history of recent medication use within the past 4 Weeks such as migraine prophylactic agents before the start of baseline observation period 2.Headaches Other Than Migraine: Presence of other primary or secondary headache disorders.
- •The participants with known history of severe primary Psychiatric disorders (Depression, Anxiety, Psychosis) with Generalized Anxiety Disorder (GAD) score greater than14, major medical illness (Renal, Hepatic, Neurological and Cardiac diseases), Pregnancy,
- •Patients with known history of severe uncontrolled systemic disorders such as Hypertension, Cardiac problems, Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, and malignant disease.
研究者
Dr Sheela Karalam B
Vaidyaratnam Ayurveda research Institute