A single arm, open label, interventional study to evaluate the safety, efficacy and tolerability of NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON for pain relief in patients with migraine headache disorders

Amrutanjan Health Care Limited, Tamil Nadu, India1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2025年6月26日最近更新: 2025年6月14日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 24
试验地点: 1
主要终点: 1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-arm, open-label clinical study designed to evaluate the safety, effectiveness, and tolerability of the NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON in individuals suffering from migraine headache disorders.

A total of 24 adult participants diagnosed with migraine (as per international criteria) will be enrolled. The study involves the topical application of the roll-on to areas like the temples, behind the ears, and the back of the neck within 2 hours of headache onset. If pain relief is not achieved within 2 hours, participants may use rescue medications (NSAIDs).

Participants will be observed over a short period of 2 days, with follow-up assessments conducted at the clinical facility on Day 2. They will use the roll-on two to three times in a day as needed.

The primary outcomes include:

Time taken to experience pain relief and complete pain relief
Change in pain severity (using a numeric pain scale and the McGill Pain Questionnaire)
Overall satisfaction with the product (using a 7-point Likert scale)

Secondary outcomes include monitoring for any adverse events (AEs) or serious adverse events (SAEs) within 24 hours.

This study aims to assess whether the NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON offers fast and effective relief for migraine sufferers in a safe and well-tolerated manner.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Participants of either gender, aged 18 – 65 years.
•Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
•Participants who are diagnosed with migraine-type headache (Common Migraine, Classical Migraine, Ophthalmic Migraine and Basilar Migraine) as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria.
•Participants with pain score greater than or equal to 3/10 (based on numeric pain rating scale) during the past 1 week.
•Migraine attacks present for more than 1 year.
•Migraine attacks, on average, lasting about
•72 hours if untreated.
•1 to 8 migraine days per month on average across the 3 months prior to the Screening Visit
•Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the screening visit and throughout the screening phase.

排除标准

•Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.
•Pregnant or lactating participants
•Inability to distinguish other headaches from migraine
•History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as participants who have not responded to an adequate dose and duration of treatment
•Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
•Chronic opioid therapy (greater than 3 consecutive days in the 30 days prior to screening)
•Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome
•Known allergy to compounds of test product.
•Participants suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
•Participation in an investigational drug trial during the last 30 days.
•Immuno-compromised (history) individuals like known HIV positive participants or participants who are on treatment with steroids or immunomodulators.
•Participants of vulnerable group (e.g. seriously ill, mentally challenged).
•History of drug or alcohol abuse during the last 3 months.