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Oleogel preparation of Chamomile oil and study of its effects in migraine without aura headache attack via double blind randomized clinical trial with placebo control

Oleogel preparation of Chamomile oil and study of its effects in migraine without aura headache attack via double blind randomized clinical trial with placebo control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014110819860N1
Enrollment
66
Registered
2014-12-05
Start date
2014-11-30
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine without aura [common migraine]. Migraine without aura [common migraine]

Interventions

Intervention 1: Intervention: 2 ml of chamomile oil oleogel is applied topically on forehead, temporal and behind ears when headache is started. It will be done two times of migraine attack. Intervent
Treatment - Drugs
Placebo
Intervention: 2 ml of chamomile oil oleogel is applied topically on forehead, temporal and behind ears when headache is started. It will be done two times of migraine attack.
2 ml of placebo oleogel is applied topically on forehead, temporal and behind ears when headache is started. It will be done two times of migraine attack.

Sponsors

Vice Chancellor for research of Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients between 18 and 65 years; having a definite diagnosis of migraine headache according to the standards of the International Headache Society (IHS 1.1); at least a 1 year history of migraine; first attack started under the age of 50 years; with 1–6 migraine attacks per month Exclusion criteria: Patients who had a history of eczema and any kind of hypersensitivity reaction; any skin lesion in the temporal and forehead areas of the head; severe headache which does not respond to at least three types of abortive behind the counter medications; headache lasting more than 15 days per month for 3 months or more; a history of any neurological disorder except migraine; receiving any medication for prophylaxis of migraine from 1 month before the beginning of the study; pregnancy; breast feeding; inability to read comprehend and complete diary forms

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Migraine headache amount. Timepoint: two attacks (drug) Two attacks (Placebo). Method of measurement: Visual Analogue Scale (VAS).

Secondary

MeasureTime frame
Nausa. Timepoint: 24 hours after using each drug. Method of measurement: Visual Analogue Scale (VAS).;Vomiting. Timepoint: 24 hours after using each drug. Method of measurement: Visual Analogue Scale (VAS).;Photophobia. Timepoint: 24 hours after using each drug. Method of measurement: Visual Analogue Scale (VAS).;Phonophobia. Timepoint: 24 hours after using each drug. Method of measurement: Visual Analogue Scale (VAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Arman Zargaran

Shiraz University of Medical Sciences

zargarana@sums.ac.ir+98 71 3239 4279

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026