a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)
NCT ID: NCT00672607
Last Updated: 2009-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2005-02-28
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
extracts of Vitex agnus castus tablets
orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
2
Placebo
Placebo
Interventions
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extracts of Vitex agnus castus tablets
orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 45 years
* Patients is in general good health
Exclusion Criteria
* Clearly kidney or liver disease, abnormal kidney or liver function.
* Any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma.
* Prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.
18 Years
45 Years
FEMALE
No
Sponsors
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Schwabe-Wenex International Ltd
INDUSTRY
Responsible Party
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Schwabe-Wenex
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Other Identifiers
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Schwabe-Wenex
Identifier Type: -
Identifier Source: org_study_id
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