Ginger Capsules for the Prophylactic Treatment of Migraine

NCT02570633 | Completed DMC

• 1 other identifier: CAAE 28236814.3.0000.5149
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

Conditions

Migraine

Keywords

Migraine; Ginger; Prophylactic treatment

Outcome Measures

Primary Outcomes (1)

• Change in the frequency of migraine attacks.

  Frequency of migraine attacks will be assessed by headache diary.

  12 weeks

Secondary Outcomes (4)

• Change in migraine impact in the last month.

  4 weeks

• Change in migraine impact in the last three months.

  12 weeks

• Changes in the serum levels of biomarkers.

  12 weeks

• Changes in Resting Energy Expenditure

  4, 8 and 12 weeks

Study Arms (2)

Extract of ginger

EXPERIMENTAL

Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks.

Other: Extract of ginger

Cellulose

PLACEBO COMPARATOR

Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.

Other: Cellulose

Interventions

Extract of ginger OTHER

Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks.

Extract of ginger

Cellulose OTHER

Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.

Cellulose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60 years old;
• Migraine diagnosis;
• Agree to sign the informed consent.

You may not qualify if:

• Patients with headaches not characterized as migraine;
• Pregnant or lactating women;
• Fertile and sexually active women who do not use contraception;
• Abuse of painkillers, alcohol or other drugs;
• People with hypersensitivity to ginger compounds;
• People with severe neurological diseases (e.g. epilepsy)
• People in use of anticoagulant drugs.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Ambulatório Bias Fortes

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (1)

• Martins LB, Rodrigues AMDS, Monteze NM, Tibaes JRB, Amaral MHA, Gomez RS, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger (Zingiber officinale Rosc.) in the prophylactic treatment of migraine. Cephalalgia. 2020 Jan;40(1):88-95. doi: 10.1177/0333102419869319. Epub 2019 Aug 9.

  PMID: 31398997 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Adaliene VM Ferreira, PhD

  Federal University of Minas Gerais

  STUDY DIRECTOR

• Laís B Martins, Ma

  Federal University of Minas Gerais

  STUDY CHAIR

• Antônio L Teixeira, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 7, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

BR (1)