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Sponsored by: |
PhytoHealth Corporation |
---|---|
Information provided by: | PhytoHealth Corporation |
ClinicalTrials.gov Identifier: | NCT00693667 |
The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis.
The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: PH3 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double-Blind, Randomized, Placebo-Controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women |
Estimated Enrollment: | 100 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Placebo Comparator
Placebo
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Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.
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B: Active Comparator
250 mg active ingredient
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Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.
|
C: Active Comparator
500 mg active ingredient
|
Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.
|
D: Active Comparator
750 mg active ingredient
|
Drug: PH3
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.
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Ages Eligible for Study: | 40 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
Taipei Veteran General Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Hui Chuan Huang 886-2-2545-3697 ext 314 huichuan@phytohealth.com.tw | |
Contact: Hsiang Ling Ho 886-2-2545-3697 ext 319 irisho@phytohealth.com.tw |
Principal Investigator: | Hsiang Tai Chao, Ph.D | Taipei Veterans General Hospital,Taiwan |
Responsible Party: | PhytoHealth Corporation ( Hui-Chuan Huang/Project Manager ) |
Study ID Numbers: | PH-CP011, 93-EC-17-A-17-I1-0034 |
Study First Received: | February 19, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00693667 |
Health Authority: | United States: Food and Drug Administration; Taiwan: Department of Health |
osteoporosis postmenopausal women botanical drug |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |