To check the effect of Migraine -XS tablet in patients having Migraine

Not Applicable

Recruiting

Brief Summary: Migraine is a spectrum disease, usually manifesting as an episodic or chronic primary headache disorder, characterized by attacks that can last from a few hours to up to three days. It is two to three times more prevalent among women than men, and women experience higher levels of pain, longer lasting attacks, and greater disability than men. For much of the twentieth century, migraineâ€™s causes were considered to be vascular, and the pain a result of dilation of the cranial blood vessels. Since the 1970s, the emphasis has shifted, and it is now defined as a disorder involving nerve pathways and chemicals in the brain, to which people are often genetically predisposed. While migraine is still understood to affect the neurovascular system, it seems likely that the headache pain comes from neurogenic inflammation, rather than vasodilation. This is a problem of brain function, rather than structure. As the website for the National Migraine Centre in London explains, â€œif the brain is a computer, migraine is a software not a hardware problem.â€ Nevertheless, a huge amount remains unknown, including the role of the hypothalamus (the part of the brain that controls the endocrine system and has a role in the menstrual cycle, pain modulation, and governance of the bodyâ€™s circadian rhythms), the cause of premonitory symptoms, the extent to which antimigraine drugs can access the brain, and the role of the blood-brain barrier.

Recruitment & Eligibility

Inclusion Criteria

1.Subjects of either sex 2.Age 18-65 years (both inclusive) 3.People who have severe pain at half portion of their head.
4.If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
5.Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
6.Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
7.Are willing to refrain from using any lotions, gel, balm, other than those issued as part of the study, on the treatment areas during the treatment period.

Exclusion Criteria

1.Are pregnant, breast-feeding, or planning to become pregnant during the study.
2.Cluster headache patients(its different from migraine) 3.Have participated in any interventional clinical trial in the previous 30 days.
4.Have a known sensitivity to any of the constituents of the test products .
5.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.

Primary Outcome Measures

Name	Time	Method
Change in the Subject Global Assessment	day 0 and Day 30

Secondary Outcome Measures

Name	Time	Method
Change in Migraine Severity scores (MIGSEV)	day 0 and Day 30
Change in Migraine Disability Assessment(MIDAS) score	day 0 and Day 30
change in pain (0-4)	day 0 and Day 30

Locations (1): Shree Ram Hospital
🇮🇳
Meerut, UTTAR PRADESH, India
Shree Ram Hospital
🇮🇳Meerut, UTTAR PRADESH, India
Dr Rakhi Mehra
Principal investigator
7906672912
raakhimehra49@gmail.com