To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.
NCT ID: NCT03245710
Last Updated: 2020-04-29
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-02-08
2021-03-07
Brief Summary
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Detailed Description
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Investigators investigate the efficacy and mechanism of traditional Chinese medicine formula powder product in the treatment of osteopenia patients with pain.This trial is a 12 weeks' randomized, placebo-controlled study. The study was approved by the Wan Fang hospital, and signed informed consent was obtained from each participant. 80 Osteopenia participants with pain were enrolled in this study. There were 80 participants aged 50 years or older included. Before random assignment to treatment, participants were at least moderate pain during 2 weeks as identified by visual analogue scale (VAS) for more than 4. Bone mineral density (BMD) of all participants was -2.5 or below without diabetes, hyperthyroidism, hypoparathyroidism, liver or kidney function disorder, ovariectomy, rheumatoid arthritis, bone cancer, ever used hormone agent within 6 months before assignment to treatment, ever used steroids more than 3 week before assignment to treatment, Primary outcome measures were the change of VAS scale, Oswestry Disability Index and WHOQOL-BREF Taiwan at week 1 and 12. Secondary outcome was the genetic loci associated with a susceptibility to osteoprosis treated by traditional Chinese medicine formula powder product.
Result : To provide evidence of the efficacy and mechanisms of ZBP powder product in the treatment of osteoporosis patients with pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zhibai Dihuang powder
Arm: Experimental: Zhibai Dihuang Formula powder Zhibai Dihuang Formula powder: Traditional Chinese medicine formula powder product 5g by mouth, after meal, 3 times in one day for 12 weeks
Zhibai Dihuang powder
the Traditional Chinese Medicine Formula Powder Product
placebos
Arm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks
Placebos
starch
Interventions
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Placebos
starch
Zhibai Dihuang powder
the Traditional Chinese Medicine Formula Powder Product
Eligibility Criteria
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Inclusion Criteria
2. VAS score≧4.0 in a week.
3. bone mineral density (BMD) of all participants was -2.5 or below.
Exclusion Criteria
2. thyroidism function disorder.
3. parathyroidism function disorder.
4. liver or kidney function disorder.
5. ovariectomy
6. rheumatoid arthritis.
7. bone cancer.
8. ever used hormone agent within 6 months before assignment to treatment.
9. ever used steroids more than 3 months before assignment to treatment.
10. ever used analgesics, excepted acetaminophen, more than 1 week before assignment to treatment.
50 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Principal Investigators
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Chung-Yu Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Municipal WanFang Hospital
Locations
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WanFangH
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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N201602096
Identifier Type: -
Identifier Source: org_study_id
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