NCT01271647

Classic Yin and Yang Tonic Formula for Osteopenia

Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteopenia

Interventions

Type	Name	Description
DRUG	Yin and Yang tonic granules	Yin and Yang tonic granules,18g per time,two times per day,six months
DRUG	placebo	granules,18g per time,two times per day,six months

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-01-01
• Completion: 2012-07-01
• First posted: 2011-01-07
• Last updated: 2011-07-28

Locations

1 site across 1 country: China