OsteopeniaCYYTONCT01271647
Classic Yin and Yang Tonic Formula for Osteopenia
A study testing Yin and Yang tonic granules in people with Osteopenia, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteopenia
- What is being tested?
- Yin and Yang tonic granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital
Shanghai, Shanghai Municipality, 200032
xuejun cui, Dr., 0086-18917763017, diyicuixj@163.com
feng yang, Dr., 0086-15001721036, yangfengdudu@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteopenia
- Being tested
- Yin and Yang tonic granules, placebo
- Keywords
- osteopenia,chinese herb
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yin and Yang tonic granulesDrug
Also called Zuo and You gui Granules
Yin and Yang tonic granules,18g per time,two times per day,six months
placeboDrug
Also called Zuo and You gui Granules
granules,18g per time,two times per day,six months
| Study group | Role | What they receive |
|---|---|---|
| chinese herb | Experimental | Not described Receives: Drug: Yin and Yang tonic granules |
| placebo | Experimental | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
Measured: 6 months
Secondary outcomes (1)
pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.
pain visual analogue scales:6month ECOS-16 questionnaire:6month bone metabolism,NEI:6month
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Investigators
- feng yang, doctor, Study director, Shanghai UTCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271647
- Sponsor's protocol ID
- LHCTOP2011
- Acronym
- CYYTO
- Status last verified
- Jan 2011
- First submitted
- 3 Jan 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21806837
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Classic Yin and Yang Tonic Formula in Osteopenia
- ClinicalTrials.gov ID
- NCT01271647
- Acronym / sponsor ID
- CYYTO / LHCTOP2011
- Conditions
- Osteopenia
- Keywords
- osteopenia,chinese herb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chinese herb | Experimental | Drug: Yin and Yang tonic granules |
| placebo | Experimental | Drug: placebo |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yin and Yang tonic granulesAlso: Zuo and You gui GranulesYin and Yang tonic granules,18g per time,two times per day,six months | Drug | chinese herb |
| placeboAlso: Zuo and You gui Granulesgranules,18g per time,two times per day,six months | Drug | placebo |
Primary outcome
bone mineral density
Time frame: 6 months
1 secondary outcome
pain visual analogue scales,ECOS-16 questionnaire,bone metabolism,NEI.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Derived from this study: PubMed 21806837Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
feng yang, doctor study director
Shanghai UTCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yin and Yang tonic granules in people with Osteopenia, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yongjun wang, doctor (0086-21-64385700-6403, yjwang88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.