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

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03245710

Collaborator

(none)

Enrollment

Location

Arms

48.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia	Other: Placebos Dietary Supplement: Zhibai Dihuang powder	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 8, 2017

Anticipated Primary Completion Date :

May 7, 2020

Anticipated Study Completion Date :

Mar 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Dietary Supplement: Zhibai Dihuang powder the Traditional Chinese Medicine Formula Powder Product
Placebo Comparator: placebos Arm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks	Other: Placebos starch

Arm

Intervention/Treatment

Experimental: 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

Dietary Supplement: Zhibai Dihuang powder

the Traditional Chinese Medicine Formula Powder Product

Placebo Comparator: placebos

Arm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks

Other: Placebos

starch

Outcome Measures

Primary Outcome Measures

Pain on the visual-analogue scales (VAS) for back and legs. [baseline and week 12]
A VAS is a 100-mm-long horizontal line that is anchored by word descriptors at each end (no pain and worst pain possible). The patient selects the point on the line that best represents his or her perception of their pain level.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

diabetes.
thyroidism function disorder.
parathyroidism function disorder.
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 months before assignment to treatment.
ever used analgesics, excepted acetaminophen, more than 1 week before assignment to treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WanFangH	Taipei		Taiwan	116

Sponsors and Collaborators

Taipei Medical University WanFang Hospital

Investigators

Principal Investigator: Chung-Yu Huang, MD, Taipei Municipal WanFang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Medical University WanFang Hospital

ClinicalTrials.gov Identifier:

NCT03245710

Other Study ID Numbers:

N201602096

First Posted:

Aug 10, 2017

Last Update Posted:

Apr 29, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Diseases, Metabolic

Study Results

No Results Posted as of Apr 29, 2020