Clinical trial NCT04812236: Clinical Study on Wuling Powder in Treating Metabolic Syndrome of Spleen Deficiency and Dampness
Official title: A Randomized, Partially Double-blind, Controlled, Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency, Dampness and Sleepiness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metabolic Syndrome
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The research purpose of this project is to observe the effectiveness and safety of Wulingsan single decoction granules compared with traditional powder, co-decoction granules and analogues in the treatment of metabolic syndrome in combination with conventional therapies. ; Compared with Wulingsan traditional powder and co-decoction granule group, observe the effectiveness and safety of traditional powder combined with conventional therapy in the treatment of metabolic syndrome. The trial adopts a randomized, partially double-blind, controlled, multi-center clinical research method. A total of 320 cases were included in 4 groups, namely, single decoction group, co-decoction group, powder group, and simulated agent 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 the observation period is set to 12 weeks. Follow up every 4 weeks.

Eligibility 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.

Primary outcomes:
measure: Analysis of changes in waist-to-hip ratio at 12 weeks
timeFrame: 12 weeks
measure: Analysis of body mass index changes in 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement of the conversion score of phlegm-damp constitution judgment
timeFrame: 12 weeks
measure: Lipid Index
timeFrame: 4 weeks，8 weeks，12 weeks
measure: Fasting blood glucose index
timeFrame: 4 weeks，8 weeks，12 weeks
measure: 2h blood glucose after meal
timeFrame: 4 weeks，8 weeks，12 weeks
measure: HOMAA insulin resistance index
timeFrame: 12 weeks
measure: Blood pressure index
timeFrame: 4 weeks，8 weeks，12 weeks
measure: Inflammatory factors
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: