NCT01135784

Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache

Human CT: Efficacy & Safety of MIGRA-ZEN RELIEF PLUS:Herbal Supp:Extracts Juniper Willow Goldenrod Dandelion Meadowsweet Whole Grape In Rx of Chronic Migraine Headache. Randomized, Double-Blind, Placebo Cont. Study P.II (PoC Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: RZN Nutraceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study MIGRA-ZEN RELIEF PLUS, an all-natural herbal dietary supplement product, with respect to alleviating and/or stopping migraine headache pain compared to a placebo when used prophylactically. This study will involve subjects suffering from chronic migraine headaches.

Detailed description

The purpose of this 90-day, randomized, double-blind, placebo controlled study is to evaluate the efficacy of an all-natural herbal dietary supplement product, (Investigational Product, or IP), with respect to alleviating and/or stopping migraine headache pain compared to a placebo when used prophylactically every day, and to evaluate the safety/risk of its use by observing the absence/presence of adverse event (AE/SAE) reports and the normalcy of blood work, urinalysis, and liver enzyme tests. The primary end-point is the time-course and depth of the frequency reduction of migraine attacks. The secondary end-points will be the absence/presence of detectable adverse liver function and urinalysis test results as well as the dearth/abundance of AE/SAE reports that may indicate patient safety/risk when using the IP.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MIGRA-ZEN RELIEF PLUS	one 2-capsule dose per 24hrs for a total of 180 caps over 90 days
DIETARY_SUPPLEMENT	Placebo for Migrazen relief plus	2 capsule dose per 24 hours for 90 days

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2010-06-03
• Last updated: 2011-06-14

Locations

2 sites across 1 country: Israel