Classic Yin and Yang Tonic Formula for Osteopenia

Osteopenia Clinical Trial

— CYYTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01271647
• Other study ID #: LHCTOP2011
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2011
• Last updated: July 26, 2011
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2011
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: yongjun wang, doctor
• Phone: 0086-21-64385700-6403
• Email: yjwang88[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia

Intervention

Drug:
• Yin and Yang tonic granules
Yin and Yang tonic granules,18g per time,two times per day,six months
• placebo
granules,18g per time,two times per day,six months

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density		6 months	No
Secondary	pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.	pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month	6 months	Yes