type 2 diabetes and coronary heart disease with qi-yin deficiency syndrome
Conditions
Interventions
Yiqi Shengjin San Group:Addition of Yiqi Shengjin San on top of oral western medicine treatment. Yiqi Shengjin San should be taken orally with warm boiled water after an interval of 0.5h with western
placebo group:A placebo was added to the conventional oral western medicine treatment. Placebo is prepared by Beijing Institute of Traditional Chinese Medicine the dosage form is granule preparation s
Sponsors
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-80 years old (both ends inclusive) ; (2) Meet the diagnostic criteria for type 2 diabetes mellitus and stable coronary heart disease; (3) Meet the diagnostic criteria of TCM Xiaoke Disease and Chest Painbasedon; (5) Meet the diagnostic criteria of TCM syndrome differentiation standards for qi and yin deficiency syndrome; (4) patients with HbA1c in 6.0%-7.5%; (5) Not regularly taking any preparations containing traditional Chinese medicine ingredients in 1 month before enrollment; (6) The subject or his/her legal representative voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with acute myocardial infarction; (2) Non type 2 diabetes patients with elevated blood sugar. (3) Patients with acute complications of diabetes including diabetes ketosis ketoacidosis hyperosmolar coma etc. (4) Patients receiving insulin or GLP-1 receptor agonists. (5) Patients with obvious liver dysfunction (alanine aminotransferase or aspartate aminotransferase exceeding twice the upper limit of normal) or renal dysfunction (serum creatinine>265.2 umol/l); (6) Pregnant or lactating women; (7) Individuals who are allergic to the experimental drug; (8) Not willing to cooperate and mentally ill patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| seattle angina questionnaire;HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| traditional Chinese medicine syndrome scores;glucose variability;Clinical efficacy of traditional Chinese medicine syndromes;Percentage of glucose less than 3.9 mmol/L;Major Adverse Cardiovascular Events;Percentage of glucose greater than or equal to 3.9 mmol/L and less than or equal to 10 mmol/L;glucose standard deviation;Percentage of glucose greater than 10 mmol/L; | — |
Countries
China
Contacts
Public ContactSHANG-JuJu
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Outcome results
None listed