Classic Yin and Yang Tonic Formula for Osteopenia

Overview

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.

Full Title of Study: “Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2012

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: chinese herb
  • Experimental: placebo

Clinical Trial Outcome Measures

Primary Measures

  • bone mineral density
    • Time Frame: 6 months

Secondary Measures

  • pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.
    • Time Frame: 6 months
    • pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai University of Traditional Chinese Medicine
  • Collaborator
    • Ministry of Science and Technology of the People´s Republic of China
  • Provider of Information About this Clinical Study
    • yongjun wang, Shanghai UTCM
  • Overall Official(s)
    • feng yang, doctor, Study Director, Shanghai UTCM
  • Overall Contact(s)
    • yongjun wang, doctor, 0086-21-64385700-6403, yjwang88@hotmail.com

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