Study on the Intervention Effect on Patients with Metabolic Syndrome of Dampness Syndrome

Phase 1

• Conditions: Metabolic syndrome

• Registration Number: ITMCTR2200006575
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.18-70 years old.
2.Those who meet the typical diagnosis of dampness syndrome in the Diagnostic Standard of Dampness Syndrome of Traditional Chinese Medicine V2.0.
3.Those who meet the diagnosis of metabolic syndrome in the Chinese Guidelines for The Prevention and Treatment of Type 2 Diabetes (2017 Edition).
4.Those who volunteer to participate in the study of this subject and sign informed consent forms.

Exclusion Criteria

1. Patients with secondary abnormal blood glucose, blood lipids and blood pressure caused by nephrotic syndrome, hypothyroidism, renal failure, liver disease, systemic lupus erythematosus, myeloma, glycogen accumulation, lipoatrophy, acute porphyria and polycystic ovary syndrome.
2. Patients with dysglycemia caused by drugs (phenothiazines, ß-blockers, adrenocortical steroids, etc.).
3. Patients with systolic blood pressure = 180mmHg or diastolic blood pressure = 110mmHg after treatment.
4. Patients whose fasting blood glucose is still = 11.1mmol/L after drug treatment.
5. Patients with total cholesterol = 6.22mmol/L (240mg/dL) or low density lipoprotein cholesterol = 4.92mmol/L (190mg/dL) or triglyceride = 3.39 mmol/L after oral drug treatment.
6. Patients with malignant tumor, severe heart disease, hematological disease, cerebrovascular accident, severe trauma or major operation.
7. Pregnant or lactating women or those who plan to become pregnant during the trial or whose spouse plans to conceive.
8. People with allergies, who may be allergic to this drug or are mentally ill.
9. Other patients who can't cooperate for a long time.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantity of metabolically abnormal components;Score of Dampness Syndrome Scale;

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose;High density lipoprotein cholesterol (HDL-C);Interleukin-6;Insulin resistance index;Low density lipoprotein cholesterol (LDL-C);HbA1c;Triglyceride (TG);C-reactive protein (CRP);Total cholesterol (TC);Blood pressure;Uric acid (UA);Body mass index (BMI);Tumor necrotic factor-a (TNF-a);Waist;