Osteopenia
Conditions
Keywords
osteopenia,chinese herb
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.
Interventions
DRUGYin and Yang tonic granules
Yin and Yang tonic granules,18g per time,two times per day,six months
DRUGplacebo
granules,18g per time,two times per day,six months
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone mineral density | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI. | 6 months | pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month |
Countries
China
Contacts
Primary Contactyongjun wang, doctor
Backup Contactfeng yang, doctor
Outcome results
None listed