Classic Yin and Yang Tonic Formula for Osteopenia

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborator: Ministry of Science and Technology of the People´s Republic of China

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.