Overview

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 PeopleĀ“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.