NCT02998944

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,748

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

December 4, 2016

Last Update Submit

December 16, 2016

Conditions

Outcome Measures

Primary Outcomes (5)

  • hypertension

    questionaire

    through study completion, an average of 2 year

  • diabetes mellitus

    questionaire

    through study completion, an average of 2 year

  • coronary artery disease

    questionaire

    through study completion, an average of 2 year

  • COPD

    questionaire

    through study completion, an average of 2 year

  • Obesty

    calculation from height and weight

    through study completion, an average of 2 year

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • severity renal and liver function abnormal and pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27736036BACKGROUND
  • 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.

    PMID: 27729462BACKGROUND

MeSH Terms

Conditions

HypertensionDiabetes MellitusCoronary Artery DiseaseObesity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

December 4, 2016

First Posted

December 21, 2016

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

November 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share