Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine

NCT ID: NCT05072990

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-05-15

Brief Summary

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This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.

Detailed Description

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The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).

Conditions

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Type 2 Diabetes Mellitus in Obese Dyslipidemia Associated With Type II Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational group

Chinese herb medicine

Intervention Type DRUG

Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.

Interventions

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Chinese herb medicine

Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Meet at least three of the requirements below; 1) Fasting Plasma Glucose \> 6.1 mmol/L or 2-hour Postprandial Blood Glucose \> 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index \> 25 kg / m2; 3) Total Cholesterol \> 5.2 mmol / L; Or Triglyceride \> 1.70 mmol / L; Or Low-Density Lipoprotein \> 3.12 mmol / L; Or High-Density Lipoprotein \< 1.04 mmol/L. 4) Systolic blood pressure \> 130 mmHg or Diastolic blood pressure \> 85 mmHg or diagnosed as hypertension;
2. Received 6 months of continuous Chinese herbal medicine treatment;
3. During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
4. During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
5. Aged 18 to 80 years at the time of their consent;
6. Signed informed consent.

Exclusion Criteria

* Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jiaxing Tian

Attending Physician, Department of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiaxing Tian, PhD

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

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Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2020-035-KY

Identifier Type: -

Identifier Source: org_study_id

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