Status:
ACTIVE_NOT_RECRUITING
Assessing the Therapeutic Potential of a Traditional Botanical Remedy for Menstrual Pain: Insights From a Prospective Observational Analysis
Lead Sponsor:
University of Zurich
Conditions:
Dysmenorrhea Primary
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Primary dysmenorrhea (PDM) affects round 60 to 90% of women and has a great impact on everyday life of affected women, leading to decreased work productivity, cognitive activity and cuts in social lif...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age between 18 and 45 years with regular menstrual cycles (21-35 days)
- Menstrual pain rated 6 or higher on an 11-point PI-NRS during the most painful day
- In good general health
- Provided written informed consent
- Willing to maintain the same personal hygienic product throughout the study (e.g., tampons, pads, menstrual cups; no changes in menstrual hygiene practices allowed during the study)
- Exclusion Criteria
- Secondary dysmenorrhea (i.e. in endometriosis, adenomyosis, urogenital malformations)
- Currently taking, or had taken in the past two months, hormonal forms of birth control
- Dysmenorrhea reasonably suspected to be due to a IUD
- Prior or current liver or kidney disease, inflammatory bowel disease, reproductive cancer (uterine, ovarian, etc.)
- Personal history of known hypersensitivity to the used drug or its ingredients or to drugs with a similar chemical structure
- Other diseases that do not allow the subject to assess the nature and scope as well as possible consequences of the clinical study
- Pregnant or breastfeeding women
- Signs that the subject is unlikely to comply with the protocol (e.g., unwillingness to cooperate)
- Alcohol/drug abuse
- Non-German speaking patients (Patient information is only available in German)
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06908044
Start Date
January 1 2025
End Date
December 31 2028
Last Update
April 10 2025
Active Locations (2)
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1
Private Centre for Obstetrics and Gynecology "Geburt und Familie"
Aarau, Canton of Aargau, Switzerland, 5000
2
Paracelsus Zentrum am Grossmünster
Zurich, Canton of Zurich, Switzerland, 8001