Classic Yin and Yang Tonic Formula for Osteopenia (CYYTO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01271647
First received: January 3, 2011
Last updated: July 26, 2011
Last verified: January 2011

January 3, 2011
July 26, 2011
February 2011
January 2012   (final data collection date for primary outcome measure)
bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01271647 on ClinicalTrials.gov Archive Site
pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month
Same as current
Not Provided
Not Provided
 
Classic Yin and Yang Tonic Formula for Osteopenia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteopenia
  • Drug: Yin and Yang tonic granules
    Yin and Yang tonic granules,18g per time,two times per day,six months
    Other Name: Zuo and You gui Granules
  • Drug: placebo
    granules,18g per time,two times per day,six months
    Other Name: Zuo and You gui Granules
  • Experimental: chinese herb
    Intervention: Drug: Yin and Yang tonic granules
  • Experimental: placebo
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
55 Years to 75 Years
No
Contact: yongjun wang, doctor 0086-21-64385700-6403 yjwang88@hotmail.com
Contact: feng yang, doctor 008615001721036 yangfengdudu@163.com
China
 
NCT01271647
LHCTOP2011
Yes
yongjun wang, Shanghai UTCM
Shanghai University of Traditional Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Study Director: feng yang, doctor Shanghai UTCM
Shanghai University of Traditional Chinese Medicine
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP