Treatment of Headache with Unani formulation using hydrotherapy

Phase 2

Completed

Conditions: CHRONIC MIGRAINE

Registration Number: CTRI/2018/03/012584

Lead Sponsor: National Institute of Unani Medicine

Brief Summary: *Shaqiqa* (migraine) is type of Headache which is typically unilateral but sometimes bilateral and moderate to severe in intensity. Migraine is the second most prevalent brain disorder after anxiety. It has two major clinical subtypes, migraine without aura (common migraine) which occurs in about 80 to 85% of patient and migraine with aura (classical migraine) which occurs in about 15 to 20% of patients. In US the direct and indirect cost associated with migraine is over $20 billion annually. The Global Burden of Disease Study 2010 (GBD2010) ranked tension type headache (TTH) and migraine as the second & third most common disease worldwide. According to the World Health Organizationâ€™s 2012 global burden of disease, the cumulative burden of the disorder caused it to rank in the top 40 conditions causing worldwide disability. A study conducted at Bangalore in 2016 shows out of total cases of headache yesterday, 46.3% were migraine headache. Thus, it is understandable that migraine is one of the leading disabling causes in adults and high burden of disease. Thus effective treatment of migraine is needed with fewer side effects. Despite having effective treatment for acute migraine attacks (such as Triptans) the response rate varies from 44-70%. Some patients do not get relief by 2 hours after taking oral migraine medications, and recurrence of headache within 24 hours of initial dosing is common. In addition these medicines have adverse effects such as NSAIDs cause dyspepsia and gastrointestinal irritation; Ergotamine may cause nausea. Triptans which are considered as important medicine for acute migraine treatment are generally not effective in migraine with aura unless given after the aura is completed and the headache initiated, and recurrence of headache within usual time of course of an attack occurs in most of the patients. The prophylactic agents available have limited efficacy and may cause adverse effects and not compatible for long term use. Unani physicians have successfully treated *Shaqiqa* since ancient times without any significant side effects on the basis of the principles of *Tanqia Mawad-i-Raddiya and Taqwiat-i- Dimagh* achievedbyusing *Munzij wa Musâ€™hil and Nutul, SaÊ¹oot wa Zimad**.* Keeping this in view, a study is planned to evaluate the efficacy of Unani treatment in management of Migraine using *Nutul-i-Har* on affected side. The goals of managing migraine are to reduce migraine frequency, severity, disability and improve the quality of life.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Clinically diagnosed Patients of chronic migraine as per ICHD criteria12 2.Patients aged between 18 â€“60 years 3.Either gender 4.Willing to fill daily headache diary 5.Patient willing to sign written informed consent.

Exclusion Criteria

1.Non-migraineous headache: tension-type headache; cluster headache; chronic paroxysmal or non-paroxysmal hemicranias 2.Familial hemiplegic migraine 3.Below 18 and above 60 years 4.Pregnancy and Lactation 5.H/O Neuropsychiatric illness 6.H/O any systemic illness or metabolic disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue scale (VAS)	0, 15, 30, 45, 60, 90th day
Migraine disability assessment (MIDAS)	0, 15, 30, 45, 60, 90th day

Secondary Outcome Measures

Name	Time	Method
MSQL	0,30,60, 90

Trial Locations

Locations (1): National Institute of Unani Medicine
🇮🇳
Bangalore, KARNATAKA, India
National Institute of Unani Medicine
🇮🇳Bangalore, KARNATAKA, India
MOHD UMAR AFZAL
Principal investigator
07977190855
drmuafzal@gmail.com