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To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.

T

Taipei Medical University

Status

Unknown

Conditions

Osteopenia

Treatments

Dietary Supplement: Zhibai Dihuang powder
Other: Placebos

Study type

Interventional

Funder types

Other

Identifiers

NCT03245710
N201602096

Details and patient eligibility

About

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.

Full 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 -2.5 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.

Enrollment

80 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. aged 50 years or older.
  2. VAS score≧4.0 in a week.
  3. bone mineral density (BMD) of all participants was -2.5 or below.

Exclusion criteria

  1. diabetes.
  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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups, including a placebo group

Zhibai Dihuang powder
Experimental group
Description:
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
Treatment:
Dietary Supplement: Zhibai Dihuang powder
placebos
Placebo Comparator group
Description:
Arm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks
Treatment:
Other: Placebos

Trial contacts and locations

1

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Central trial contact

Chung-Yu Huang, MD

Data sourced from clinicaltrials.gov

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