Kidney Yang Deficiency SyndromeNCT01940380
The Study of LTBP1 of Postmenopausal Women Osteoporosis Molecular Mechanism of Kidney Yang Deficiency Syndrome
An observational study of Kidney Yang Deficiency Syndrome, run by Fujian Academy of Traditional Chinese Medicine at 1 site in China.
Trial summary
Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kidney Yang Deficiency Syndrome
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to 9 Dec 2016
- Phase
- Observational
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female ages 45 to 75 had gone through natural menopause before two years
Who may be able to join
- • The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
- Female ages 45 to 75 had gone through natural menopause before two years
- In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
- In accordance with the western medicine diagnostic criteria;
- In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study
Who cannot join
- Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
- Age: <44 and > 76 years old;
- With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
- With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
- Psychosis or alzheimer's patients;
- Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;
- This medicine allergic constitution or composition of known to have allergies;
- In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Institute of Trational Chiness Medicine
Fuzhou, Fujian, 350003
About this study
Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Previous studies have found that POP molecular regulation mechanism of kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.
This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.
- Conditions
- Kidney Yang Deficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Postmenopausal Osteoporosis of kidney Yang deficiency syndrome
Measured: To observe the changes in gene expression(Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion1 Dec 2013
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Yang Deficiency SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Academy of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940380
- Sponsor's protocol ID
- 20130305
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2013
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of LTBP1 of Postmenopausal Women Osteoporosis Molecular Mechanism of Kidney Yang Deficiency Syndrome
- ClinicalTrials.gov ID
- NCT01940380
- Acronym / sponsor ID
- 20130305
- Conditions
- Kidney Yang Deficiency Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fujian Academy of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 12 Sep 2013 (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.
Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Previous studies have found that POP molecular regulation mechanism of kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.
This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female ages 45 to 75 had gone through natural menopause before two years
Key inclusion criteria (5 listed)
- • The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
Key exclusion criteria (8 listed)
- Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postmenopausal Osteoporosis of kidney Yang deficiency syndrome
Time frame: To observe the changes in gene expression(Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Yang Deficiency Syndrome, run by Fujian Academy 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 21 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postmenopausal Osteoporosis of kidney Yang deficiency syndrome (time frame: To observe the changes in gene expression(Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2017.