Last updated on February 2018

To Investigate the Traditional Chinese Medicine Formula Powder Product in the Treatment of Osteopenia


Brief description of study

This study investigates the efficacy and mechanism of traditional Chinese medicine formula power product in the treatment of osteopenia in patients with pain. Half of participants will receive Chinese medicine formula power product, while the other half will receive a placebo.

Detailed Study Description

Osteoporosis is a major public health problem, resulting in potentially pain and increasing risk of fracture. Treatment of osteoporosis consists of pharmacotherapy, lifestyle measures, dietary changes, mineral supplementation. Traditional Chinese medicine is a major component of health care in Taiwan and provides one treatment alternative for osteoporosis.

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 -2.0 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 1 week before assignment to treatment, ever used analgesics more than 1 week before assignment to treatment. Primary outcome measure is the change of VAS score between baseline and week 12; Secondary outcome measures are the bath ankylosing spondylitis disease activity index (BASDAI) at week 12; serum levels of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) at week 12; and to probe genetic loci associated with a susceptibility to osteopenia treated by traditional Chinese medicine formula powder product.Investigators aim to probe the efficacy and mechanisms of traditional Chinese medicine formula in the treatment of osteopenia patients with pain.

Clinical Study Identifier: NCT03245710

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Chung-Yu Huang, MD

WanFangH
Taipei, Taiwan
2.42miles
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Recruitment Status: Open


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