Osteoporosis Clinical Trial
Official title:
Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.
Verified date | February 2015 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.
Status | Completed |
Enrollment | 61 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Women aged 40-65 years - Experiencing daily hot flushes - Body Mass Index (BMI) between 20-40 - Irregular menstrual bleeding - FSH levels above the normal range Exclusion Criteria: - Simultaneous participation in other clinical trials within the last 3 months - Severe cardiovascular, psychiatric, neurological, and/or kidney disease. - Alcohol or drug abuse and acute illness. - Blood pressure > 160/110 - Pregnant and lactating women |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Clinical Research, Hospital Vendsyssel | Hjorring | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Menopause-related symptoms | To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats. | 3 months | No |
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