Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks

Shiraz University of Medical Sciences

Status: Unknown

Conditions: Migraine Headache; Gastric Diseases

Treatments: Drug: placebo; Drug: Quince's oxymel; Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02179775

90-01-64-3456

Details and patient eligibility

About

The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.

Full description

This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of oral use of "Sekanjebin e Safarjali" (Quince Oxymel) in the Prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.45 patients with Migraine headache aged between 15-70, after taking signed informed consent, according to the International headache society criteria for headache [2] are included in this trial. 45 cases with Migraine headache with simultaneous upper gastrointestinal dysfunction will allocate to three arms by using simple randomization. Quince Oxymel, propranolol and placebo will be given as encoded, innominate bottles with the same shape and color. Quince oxymel and placebo will be prescribed as 10 cc, three times a day for 4 weeks. Frequency, duration and intensity of Migraine Attacks at the beginning time and during 4 weeks of trial, will be evaluated, as the primary outcome measures.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• minimum age of 18 years old
• giving a written informed consent
• having at least 2 migraine attacks per month

Exclusion criteria

• patients older than 70 years old
• patients with Diabetes mellitus
• patients with chronic obstructive pulmonary disease and asthma
• pregnancy
• severe depression
• patients affected by sexual disorders
• bradyarrhythmic patients
• positive history of hypersensitivity reactions to quince, ginger, propranolol or naproxen

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

propranolol

Active Comparator group

Treatment:

Drug: propranolol

Quince's oxymel

Active Comparator group

Treatment:

Drug: Quince's oxymel

placebo

Placebo Comparator group

Treatment:

Drug: placebo