Measuring the effects of L-arginine and aged garlic extract on migraine in Australian adults

Not Applicable

Recruiting

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12621001476820
• Lead Sponsor: Curtin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-28
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.Migraine (with or without aura) diagnosed at least 1 year ago
2.Migraine onset occurred before 50 years of age
3.2-6 migraine episodes and fewer than 6 'other' headache types per month, over the last 3 months
4.Able to distinguish between migraine and 'other' headache types
5.Able to complete a daily diary about migraine experience
6.Able to commit to taking the 5 capsules a day for 14 weeks

Exclusion Criteria

1.Taking medications/drugs affecting vascular tone or blood pressure
2.Taking nitrate drugs or isoproterenol (often prescribed for angina or heart failure)
3.Taking more than two migraine-prevention drugs
4.Taking antidepressants or diuretics, herbs, supplements
5. Taking Sildafenil, Cialis, Spedra and any other PGE-5 inhibitor drugs
6.Taking drugs with potential blood-vessel effects (analgesics, decongestants, or antihistamines)
7.Already taking L-arginine or garlic supplements for 3 months before the study
8.Having headaches causing fainting or another medical emergency
9.Having chronic daily headaches, medication-overuse headaches and/or other secondary headache disorders
10.Having diagnoses other than migraine as the primary cause of headache
11.A change in migraine treatment in the 3 months prior to or during the study
12.Clinical reports of renal or liver dysfunction
13. Clinical risks associated with bleeding or coagulopathy or currently on blood-thinning medications such as warfarin/heparin therapy
14.Having any cardiovascular or neoplastic diseases
15.Having major chronic metabolic or neurologic disorders, or receiving current therapy for them
16.Being diagnosed with psychosis or bipolar affective disorder
17.Diagnosis of cancer
18.Substance abuse/dependence/addiction in the 3 months prior to or during the study
19.Having an history of diabetes, hypertension, collagen vascular disease, vasculitis, or renal disease/failure
20.Having any low-blood-pressure-related issues or Type-1 or -2 diabetes
21.Having the possibility of pregnancy or lactation
22.Being allergic to garlic or its constituents
23.Having gastric disturbances such as bloating, stomach pain, heartburn, diarrhoea, constipation, nausea or vomiting
24.Are a smoker
25.Having an history of eye pathology, surface disorder, surgery (except cataract extraction), injury
26.Not being able to see clearly (with glasses, if need be)
27.Having disorders of the optic nerve (including glaucoma) or retina
28.The significant possibility of our not being able to see the inside of your eye clearly
29.Having poor image perception due to cataract or unstable fixation

Study & Design

• Study Type: Interventional
• Study Design: Not specified