To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2017
CompletedFirst Submitted
Initial submission to the registry
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2021
CompletedApril 29, 2020
April 1, 2020
3.2 years
February 24, 2017
April 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Zhibai Dihuang powder
EXPERIMENTALArm: 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
placebos
PLACEBO COMPARATORArm: placebo Comparator placebos 5g by mouth after meal, 3 times in one day for 12 weeks
Interventions
the Traditional Chinese Medicine Formula Powder Product
Eligibility Criteria
You may qualify if:
- aged 50 years or older.
- VAS score≧4.0 in a week.
- bone mineral density (BMD) of all participants was -2.5 or below.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WanFangH
Taipei, 116, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Yu Huang, MD
Taipei Municipal WanFang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2017
First Posted
August 10, 2017
Study Start
February 8, 2017
Primary Completion
May 7, 2020
Study Completion
March 7, 2021
Last Updated
April 29, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share