Back to resultsClassic Yin and Yang Tonic Formula for Osteopenia (CYYTO)
Primary Purpose
Osteopenia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yin and Yang tonic granules
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia focused on measuring osteopenia,chinese herb
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Longhua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
chinese herb
placebo
Arm Description
Outcomes
Primary Outcome Measures
bone mineral density
Secondary Outcome Measures
pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.
pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month
Full Information
NCT ID
NCT01271647
First Posted
January 3, 2011
Last Updated
July 26, 2011
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
1. Study Identification
Unique Protocol Identification Number
NCT01271647
Brief Title
Classic Yin and Yang Tonic Formula for Osteopenia
Acronym
CYYTO
Official Title
Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Osteoporosis is a growing problem worldwide, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals) Since life long drug therapy is an expensive option with uncertain consequences and side effect, natural herbal therapy offers an attractive alternative. The classic Yin and Yang Tonic Formula (eg.Zuogui Pill, Yougui Pill) have been used for osteoporosis or osteopenia in traditional Chinese medicine(TCM) for a long time. For this reason, Chinese guidelines for the treatment of osteopenia include natural herbal therapy, however, there is currently no randomize placebo controlled trial to verify the efficacy for treating low BMD. This trial is randomized, double blind, placebo controlled design. Results of this study will provide evidence regarding the value of the classic Yin and Yang tonic formula as an intervention for increase BMD and decreasing fracture risk in osteopenia. Furthermore, the mechanisms of action can be identified by this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
osteopenia,chinese herb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chinese herb
Arm Type
Experimental
Arm Title
placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Yin and Yang tonic granules
Other Intervention Name(s)
Zuo and You gui Granules
Intervention Description
Yin and Yang tonic granules,18g per time,two times per day,six months
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Zuo and You gui Granules
Intervention Description
granules,18g per time,two times per day,six months
Primary Outcome Measure Information:
Title
bone mineral density
Time Frame
6 months
Secondary Outcome Measure Information:
Title
pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.
Description
pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yongjun wang, doctor
Phone
0086-21-64385700-6403
Email
yjwang88@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
feng yang, doctor
Phone
008615001721036
Email
yangfengdudu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
feng yang, doctor
Organizational Affiliation
Shanghai UTCM
Official's Role
Study Director
Facility Information:
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuejun cui, Dr.
Phone
0086-18917763017
Email
diyicuixj@163.com
First Name & Middle Initial & Last Name & Degree
feng yang, Dr.
Phone
0086-15001721036
Email
yangfengdudu@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
21806837
Citation
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.
Results Reference
derived
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Classic Yin and Yang Tonic Formula for Osteopenia
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