A holistic pharmacokinetic model of Xiexin decoction
Conditions
Interventions
Healthy group:Single dose administration of Xiexin decoction granules
The diabetes group:Continuous administration of Xiexin decoction granules for 28 days
Sponsors
Guang’anmen hospital,China Academy of chinese medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for healthy group: (1) Voluntarily signed informed consent; (2) Age 18-45 years old; (3) Calculated according to body mass index = body weight (kg)/height (m2), with a body mass index of 19- Within 24; gender is not limited. 2. Patient inclusion criteria: (1) Voluntarily signed the informed consent; (2) Those who are the diagnostic criteria for type 2 diabetes, with fasting blood glucose less than 10 mmol/L; (3) Those who are the obesity; (4)The patient has the gastrointestinal excess heat syndrome; (5) Age 30-70 years old, gender is not limited. In compliance with the above conditions, the obese patients with type 2 diabetes mellitus were included.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for healthy group: (1) Those who have previously or are currently suffering from any clinically diseases such as cardiovascular, liver, kidney, digestive tract, and mental and neurological diseases; (2) Those with a history of drug allergies; (3) Those who have regular drug use, alcoholism, and participation within 2 months Other drug trials; (4) Those who have used drugs known to damage certain organs within 3 months; (5) Those who are using other preventive or therapeutic drugs; 2. Patient exclusion criteria: (1) Individuals who have previously used insulin therapy; Those who have treated diabetes for more than 3 months in the past; Those who were treated with hypoglycemic drugs within one month before enrollment. (2) Complications of diabetes were the main symptoms; And those with serious complications such as heart, lung, liver, kidney, brain, or other serious primary diseases. (3) Blood pressure is uncontrolled or after control, with systolic blood pressure = 160mmHg or (and) diastolic blood pressure = 100mmHg. (4) In the last month, there were patients with diabetes ketosis, ketoacidosis and severe infection. (5) Those who change the type of hypoglycemic Western medicine during the enrollment treatment period; (6) Psychotic patients. (7) Pregnant, pregnant or lactating women. (8) Merging primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems; (9) Allergies to the ingredients of Xiexin Tang; And those with allergic constitution. (10) Patients who have participated in other drug clinical studies or are currently participating in other clinical studies within one month prior to participating in this study. (11) Alcoholics and/or psychoactive substances, drug abusers, and addicts within the past 5 years. (12) According to the judgment of the researchers, there are other lesions or situations that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, unstable living environment, and other situations that may lead to loss of follow-up. (13) Taking drugs or health foods that have an impact on body mass. (14) Patients with impaired liver and kidney function (ALT, AST greater than 2 times the upper limit of normal values; serum creatinine greater than the upper limit of normal values).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;blood sugar;Serum proinflammatory factor;Serum anti-inflammatory factor; | — |
Secondary
| Measure | Time frame |
|---|---|
| glucosylated serum protein; | — |
Countries
China
Contacts
Public ContactCui Hanming
Guang’anmen hospital,China Academy of chinese medical sciences
Outcome results
None listed