HypertensionNCT02998944
The Study of CCTM and Common Diseases
An observational study of Hypertension and Diabetes Mellitus, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial summary
This study aimed to explore the associations between constitutions of traditional Chinese medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study was performed to investigate the associations. A total of 3748 participants were available for analysis in this study. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease Moderate
- How many people
- 3,748 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Nov 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A risk-factor study for constitution of TCM and chronic disease was conducted in a random sample of the Chinese population. Participants aged 30-90 years were recruited from rural and urban communities in Shanghai. More than 4,000 participants were invited to a screening visit between 2011 and 2013. Written consent was obtained from all patients before the study, which was performed in accordance with the ethical standards in the Declaration of Helsinki, and approved by the Medicine Ethical Committee of the Huashan Hospital. The exclusion criteria were 1) severity renal and liver function abnormal and 2) pregnant woman. A total of 3748 participants were available to data analysis.
Who may be able to join
- Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.
Who cannot join
- severity renal and liver function abnormal and pregnant woman
About this study
Official title: the Association Study of Constitution of Traditional Chinese Medicine and Common Diseases
This study aimed to explore the associations between constitutions of traditional Chinese medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study was performed to investigate the associations. A total of 3748 participants were available for analysis in this study. The assessment of constitution of TCM was based on recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD was based on self-reported medical history. The associations were analyzed using univariate and multivariable logistic regression (MLR).
Read the detailed description
This study aimed to explore the associations between constitutions of traditional Chinese medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study was performed to investigate the associations. A total of 3748 participants were available for analysis in this study. The assessment of constitution of TCM was based on recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD was based on self-reported medical history. The associations were analyzed using univariate and multivariable logistic regression (MLR).
- Conditions
- Hypertension, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease Moderate, Coronary Artery Disease, Obesity
- Medical subject headings
- Hypertension, Diabetes Mellitus, Coronary Artery Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
not any intervention for this study
What is being measured
The primary outcome is the main question the study is designed to answer.
hypertension
questionaire
Measured: through study completion, an average of 2 year
diabetes mellitus
questionaire
Measured: through study completion, an average of 2 year
coronary artery disease
questionaire
Measured: through study completion, an average of 2 year
COPD
questionaire
Measured: through study completion, an average of 2 year
Obesty
calculation from height and weight
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 3,748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Principal investigator, Zihui Tang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998944
- Sponsor's protocol ID
- cctmcd
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fang P, Dong J, Zeng F, Tang Z. Analysis of the association between glucose profiles and beta-cell function for diabetic cardiovascular autonomic neuropathy in China. J Diabetes Investig. 2017 May;8(3):354-362. doi: 10.1111/jdi.12584. Epub 2016 Nov 25.
PubMed 27736036Lv Y, Zhou L, Tang Z, Dong J. Association and interaction analysis of diabetes mellitus and SCN10A for cardiovascular autonomic neuropathy in a Chinese population. Postgrad Med J. 2017 Jun;93(1100):344-348. doi: 10.1136/postgradmedj-2016-134202. Epub 2016 Oct 11.
PubMed 27729462
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association Study of Constitution of Traditional Chinese Medicine and Common Diseases
- ClinicalTrials.gov ID
- NCT02998944
- Acronym / sponsor ID
- cctmcd
- Conditions
- Hypertension, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease Moderate, Coronary Artery Disease, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,748 participants (actual)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Dec 2016 (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.
This study aimed to explore the associations between constitutions of traditional Chinese medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study was performed to investigate the associations. A total of 3748 participants were available for analysis in this study. The assessment of constitution of TCM was based on recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD was based on self-reported medical history. The associations were analyzed using univariate and multivariable logistic regression (MLR).
Detailed description
This study aimed to explore the associations between constitutions of traditional Chinese medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study was performed to investigate the associations. A total of 3748 participants were available for analysis in this study. The assessment of constitution of TCM was based on recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD was based on self-reported medical history. The associations were analyzed using univariate and multivariable logistic regression (MLR).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A risk-factor study for constitution of TCM and chronic disease was conducted in a random sample of the Chinese population. Participants aged 30-90 years were recruited from rural and urban communities in Shanghai. More than 4,000 participants were invited to a screening visit between 2011 and 2013. Written consent was obtained from all patients before the study, which was performed in accordance with the ethical standards in the Declaration of Helsinki, and approved by the Medicine Ethical Committee of the Huashan Hospital. The exclusion criteria were 1) severity renal and liver function abnormal and 2) pregnant woman. A total of 3748 participants were available to data analysis.
Key inclusion criteria (1 listed)
- Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.
Key exclusion criteria (1 listed)
- severity renal and liver function abnormal and pregnant woman
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 |
|---|---|---|
| not any intervention for this study | Other | – |
Primary outcome
hypertension
Time frame: through study completion, an average of 2 year
questionaire
diabetes mellitus
Time frame: through study completion, an average of 2 year
questionaire
coronary artery disease
Time frame: through study completion, an average of 2 year
questionaire
COPD
Time frame: through study completion, an average of 2 year
questionaire
Obesty
Time frame: through study completion, an average of 2 year
calculation from height and weight
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 Dec 2016.
- Background: PubMed 27736036Fang P, Dong J, Zeng F, Tang Z. Analysis of the association between glucose profiles and beta-cell function for diabetic cardiovascular autonomic neuropathy in China. J Diabetes Investig. 2017 May;8(3):354-362. doi: 10.1111/jdi.12584. Epub 2016 Nov 25.
- Background: PubMed 27729462Lv Y, Zhou L, Tang Z, Dong J. Association and interaction analysis of diabetes mellitus and SCN10A for cardiovascular autonomic neuropathy in a Chinese population. Postgrad Med J. 2017 Jun;93(1100):344-348. doi: 10.1136/postgradmedj-2016-134202. Epub 2016 Oct 11.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes Mellitus, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
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 1 inclusion and 1 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
hypertension (time frame: through study completion, an average of 2 year). The study lists 5 primary outcomes in all. 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 NCT02998944, which also lists 2 linked publications.
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 Dec 2016.