Clinical trial
Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study
Name
2020-035-KY
Description
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.
Trial arms
Trial start
2021-10-27
Estimated PCD
2022-04-30
Trial end
2022-05-15
Status
Completed
Treatment
Chinese herb medicine
Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.
Arms:
Observational group
Size
95
Primary endpoint
Change from Baseline HbA1c at 3 months, 6 months
0 month, 3 months, 6 months
Changes from Baseline Fasting Blood Glucose at 3 months, 6 months
0 month, 3 months, 6 months
Changes from Baseline Low Density Lipoprotein at 3 months, 6 months
0 month, 3 months, 6 months
Changes from Baseline Triglyceride at 3 months, 6 months
0 month, 3 months, 6 months
Changes from Baseline Body Mass Index at 3 months, 6 months
0 month, 3 months, 6 months
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 95, 'type': 'ACTUAL'}}
Updated at
2023-09-15
1 organization
1 product
2 indications
Product
Chinese herb medicineIndication
Type 2 Diabetes Mellitus