Healthy people
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Obtained informed consent; (2) Age =45 years and <75 years; (3) Ability to comply with the trial process. (4) Have sufficient cognitive ability to sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have difficulty taking oral medications due to underlying diseases etc; (2) With serious underlying diseases affecting survival including uncontrolled clinically significant cardiac pulmonary renal gastrointestinal haematological neuropsychiatric immunological metabolic diseases malignant tumours and severe malnutrition; (3) Allergic allergic to the products involved in the treatment programme; (4) Suffering from hypertension coronary heart disease diabetes mellitus hyperlipidaemia and other diseases that are not well controlled by drugs; (5) Impact on the intestinal flora including the use of drugs that may have an impact on the intestinal flora within 4 weeks prior to enrolment or taking probiotics on a daily basis suffering from inflammatory bowel disease severe intestinal obstruction that does not allow access to the faeces and so on; (6) People who in the judgement of the investigator are not suitable for the use of products involved in the treatment protocol. (7) Pregnant or lactating women; (8) People whose mental state is unable to co-operate who suffer from psychiatric illnesses who have no self-awareness or who are unable to express themselves clearly; (9) Those who are participating in other clinical trials; patients who in the judgement of the investigator will experience enrolment complications or poor compliance that will affect the assessment of efficacy and safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue scale;Information collection of four TCM diagnoses;Waist-hip ratio;Sleep quality;Glycosylated hemoglobin;Total cholesterol;Abdominal girth;High density lipoprotein;Systolic blood pressure;Low-density lipoprotein;Cognitive function;BMI;Diastolic blood pressure;waistline;triglyceride;Pulse pressure;Fasting blood glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Active ingredient metabolic process in vivo;Glucose assay;Carotid ultrasound;pwv;Sleep diary;Brachial artery flow-mediated dilation;Body composition analysis and energy metabolism test;Hypersensitive C-reactive protein; | — |
Countries
China
Contacts
Affiliated Hospital of Changchun University of Traditional Chinese Medicine