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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
History of Changes
  Purpose

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.


Condition Intervention
Osteopenia
 Drug: Yin and Yang tonic granules
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chinese herb 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
Experimental: placebo Drug: placebo
granules,18g per time,two times per day,six months
Other Name: Zuo and You gui Granules

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271647

Contacts
Contact: yongjun wang, doctor 0086-21-64385700-6403 yjwang88@hotmail.com
Contact: feng yang, doctor 008615001721036 yangfengdudu@163.com

Locations
China, Shanghai
Longhua Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: xuejun cui, Dr.     0086-18917763017     diyicuixj@163.com    
Contact: feng yang, Dr.     0086-15001721036     yangfengdudu@163.com    
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Director: feng yang, doctor Shanghai UTCM
  More Information

No publications provided by Shanghai University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: yongjun wang, Shanghai UTCM
ClinicalTrials.gov Identifier: NCT01271647     History of Changes
Other Study ID Numbers: LHCTOP2011
Study First Received: January 3, 2011
Last Updated: July 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Shanghai University of Traditional Chinese Medicine:
osteopenia,chinese herb

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013