Classic Yin and Yang Tonic Formula for Osteopenia
CYYTO
Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the classic yin and yang tonic formula for osteopenia and to research the mechanism of efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
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
First Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 28, 2011
January 1, 2011
11 months
January 3, 2011
July 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone mineral density
6 months
Secondary Outcomes (1)
pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.
6 months
Study Arms (2)
chinese herb
EXPERIMENTALplacebo
EXPERIMENTALInterventions
Yin and Yang tonic granules,18g per time,two times per day,six months
granules,18g per time,two times per day,six months
Eligibility Criteria
You may qualify if:
- BMD T-scores of the hip (femoral neck or trochanter)and/or spine between -1.0 and -2.5;
- pattern differentiation is kidney deficiency in TCM.
- informed consent.
You may not qualify if:
- Osteoporotic (T-score\< -2.5) at any site or a fracture in the past 2 years not caused by motor vehicle accident;
- prior or current use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants,lithium);
- prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene);
- use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg);
- current or prior year use of estrogen or calcitonin;
- Malignancies other than skin cancer;
- conditions that cause secondary osteoporosis (e.g. Cushing's syndrome, Marfan's syndrome);
- lactation and gestational period;
- physical or mental disabilities that will preclude informed consent or active study participation;
- supersensitivity body constitution.
- osteoporotic fracture of having operating indication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Longhua Hospital
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Yang F, Tang DZ, Cui XJ, Holz JD, Bian Q, Shi Q, Wang YJ. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial. Trials. 2011 Aug 2;12:187. doi: 10.1186/1745-6215-12-187.
PMID: 21806837DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
feng yang, doctor
Shanghai UTCM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 7, 2011
Study Start
February 1, 2011
Primary Completion
January 1, 2012
Study Completion
July 1, 2012
Last Updated
July 28, 2011
Record last verified: 2011-01