Classic Yin and Yang Tonic Formula for Osteopenia (CYYTO)

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteopenia
• Intervention / Treatment: Drug: Yin and Yang tonic granules; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital
      • Contact: xuejun cui, Dr.; Phone Number: 0086-18917763017; Email: diyicuixj@163.com
      • Contact: feng yang, Dr.; Phone Number: 0086-15001721036; Email: yangfengdudu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: placebo	Drug: placebo; granules,18g per time,two times per day,six months; Other Names: Zuo and You gui Granules
Experimental: chinese herb	Drug: Yin and Yang tonic granules; Yin and Yang tonic granules,18g per time,two times per day,six months; Other Names: Zuo and You gui Granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
bone mineral density	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Study Director: feng yang, doctor, Shanghai UTCM

Publications and helpful links

General Publications

• Yang F, Tang DZ, Cui XJ, Holz JD, Bian Q, Shi Q, Wang YJ. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial. Trials. 2011 Aug 2;12:187. doi: 10.1186/1745-6215-12-187.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 6, 2011
• First Posted (Estimate): January 7, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2011
• Last Update Submitted That Met QC Criteria: July 26, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: osteopenia,chinese herb
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: LHCTOP2011