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Study on the clinical effecy and mechanism of KaiyuTongzhi method in treating metabolic syndrome

Phase 1
Conditions
metabolic syndrome
Registration Number
ITMCTR2022000029
Lead Sponsor
Guang'anmen Hosptial
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Age 18-60 years old, gender is not limited;
(2) Central obesity: waist circumference male = 90cm, female = 85cm;
(3) Hyperglycemia: fasting blood glucose = 6.1 mmol/L or 2 h after sugar load blood glucose = 7.8 mmol/L and/or those who have been diagnosed with diabetes and treated;
(4) Hypertension: blood pressure = 130/85 mmHg (1 mmHg = 0.133 kPa) and /or has been confirmed as hypertension and treated;
(5) Fasting triglycerides (TG) = 1.70 mmol/L;
(6) Fasting HDL cholesterol (HDL-C) < 1.04 mmol/L;
(7) The TCM syndrome classification are hepatic depression stagnation and syndrome of intermingled phlegm and blood stasis.
(3)(4)(5)(6) is diagnostic with two or more items.

Exclusion Criteria

(1) Patients with serious complications of type 2 diabetes mellitus (such as diabetic nephropathy, diabetic foot, diabetic ketoacidosis, etc.);
(2) Patients with severe primary diseases such as uncontrolled hypertension, myocardial infarction, coronary atherosclerosis, cerebral infarction, infectious liver disease, kidney failure, glomerulonephritis and so on;
(3) Patients who are suspicious or have been clearly diagnosed with skin problems, soft tissue injuries, osteoarthropathy, gastrointestinal diseases, blood diseases with bleeding tendencies, etc. that are not suitable for manual treatment;
(4) Pregnant and lactation patients;
(5) Those who have a serious gastrointestinal reaction after taking metformin and cannot continue to take the drug;
(6) Patients with mental illness, cognitive dysfunction, inability to cooperate with doctors;
(7) Easy to lose visit, such as frequent changes in the working environment;
(8) Patients who are participating in other clinical trials.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Waist circumference;
Secondary Outcome Measures
NameTimeMethod
Waist-Hip Ratio;TLR4mRNA;hs-CRP;Liver ultrasound;Visceral aliphatic factor;Blood sugar;Visceral fat;HOMA-IR;Index of ß-cell function in HOMA;IL-6;TLR4;Blood pressure;NF-?B p65;NF-?B p65mRNA;TNF-a;Blood lipid;Insulin;
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