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

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.

Study Overview

• Status: Unknown
• Conditions: Osteopenia
• Intervention / Treatment: Dietary supplement: Zhibai Dihuang powder; Other: Placebos

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Recruiting
    • WanFangH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on the visual-analogue scales (VAS) for back and legs.	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.	baseline and week 12

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Chung-Yu Huang, MD, Taipei Municipal Wanfang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Anticipated): May 7, 2020
• Study Completion (Anticipated): March 7, 2021

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: N201602096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No