Clinical Study on Wuling Powder in Treating Metabolic Syndrome of Spleen Deficiency and Dampness

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and set the observation period to 12 weeks. Follow up every 4 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Criteria

Inclusion Criteria:

1. Patients who meet the diagnostic criteria of metabolic syndrome;

2. TCM syndrome differentiation of spleen deficiency and dampness patients;

3. Patients with phlegm-dampness constitution score>30;

4. Patients aged 18 to 70 years;

5. Patients who have signed informed consent and are highly compliant.

Exclusion Criteria:

1. Patients with hypertension, hyperglycemia, and hyperlipidemia caused by secondary metabolic syndrome (disease, drugs, surgery, etc.);

2. Patients with severe primary diseases such as heart, liver, kidney, lung, brain, endocrine, hematopoietic system in the past or at the time of enrollment;

3. Those who are confirmed to have acute coronary syndrome, malignant arrhythmia, and other serious heart diseases;

4. Patients with co-infection, malignant tumors or mental illness;

5. Patients with Cushing syndrome;

6. Patients with allergies or allergies to this drug;

7. Pregnant or breastfeeding women;

8. Those who have adjusted hypoglycemic, lipid-lowering, antihypertensive drugs or taking weight-loss drugs within 1 month before enrollment.