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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIGRA-ZEN RELIEF PLUS | Active Comparator | Active treatment |
|
| Placebo for Migra zen plus | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIGRA-ZEN RELIEF PLUS | Dietary Supplement | one 2-capsule dose per 24hrs for a total of 180 caps over 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The reduction of migraine attacks | The time-course and depth of the frequency in the reduction of migraine attacks | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| AEs SAEs | 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. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Lubin, MD | Contact | 305-971-3541 | mark@rznnutra.com |
| Name | Affiliation | Role |
|---|---|---|
| Amnon Mosek, MD | Saurasky Tel Aviv Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Centre | Petah Tikva | Israel |
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| Placebo for Migrazen relief plus | Dietary Supplement | 2 capsule dose per 24 hours for 90 days |
|
| Sourasky Medical Centre | Tel Aviv | Israel |
|