KCT0002576Recruiting未知
Efficacy and safety of Lycium Chinese extract complex on women with osteopenia; A 40week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
Dongwoodang0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 45(Year) to 75(Year) (—)
- Sex
- Female
Inclusion Criteria
- •1) female subjects at least more than 45years of age inclusive with menopause
- •a. have no orrhea for 12months
- •b. have last orrhea since 6months ago and FSH > 40mlU/mL
- •c. have both ovariectomy since 6weeks
- •d. have hysterectomy and FSH > 40mlU/mL
- •2) have Osteopenia by DXA(Dual energy X-ray absorptiometry)
- •3) BMI of 18.5-35.0kg/m2
- •4) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
Exclusion Criteria
- •1)The Patients with severe vitamin D which have more than 200IU per day or Calcium before 2weeks from visit2
- •2)The Patients with severe Bisphosphonate
- •3)AST(aspartate transaminase), ALT(alanine transaminase) = 2 times the upper limit of normal.
- •4)eGFR(Estimated glomerular filtration rate) value =60 mL/min/1.73 m2
- •5)The Patients who had atraumatic fracture or have lumbarcompression fracture
- •6)Subjects which in the opinion investigator could affect preclude evluation of response
Investigators
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