Clinical trial NCT02998944: The Study of CCTM and Common Diseases
Official title: the Association Study of Constitution of Traditional Chinese Medicine and Common Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes Mellitus
Chronic Obstructive Pulmonary Disease Moderate
Coronary Artery Disease
Obesity
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
First posted: 2016-12-21
Enrollment: 3748
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.

Exclusion Criteria:

* severity renal and liver function abnormal and pregnant woman

Primary outcomes:
measure: hypertension
timeFrame: through study completion, an average of 2 year
measure: diabetes mellitus
timeFrame: through study completion, an average of 2 year
measure: coronary artery disease
timeFrame: through study completion, an average of 2 year
measure: COPD
timeFrame: through study completion, an average of 2 year
measure: Obesty
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Lv 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.