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

Phase 4

• Conditions: Metabolic Syndrome
• Interventions: Drug: Wuling Powder; Drug: Wulingsan single decoction granules; Drug: Wulingsan co-decoction granules; Drug: Wulingsan granule simulant

• Registration Number: NCT04812236
• Lead Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-23
• Study Start: 2021-04-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Powder group: Wuling powder powder	Wuling Powder	Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. Take 5g each time with warm water twice a day.Take 12 weeks as a course of treatment.
Single decoction group: Wulingsan single decoction granules	Wulingsan single decoction granules	Wulingsan single decoction granules, Alisma orientalis (15g), Polyporus (10g), Baizhu (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment.
Co-decocting group: Wulingsan co-decocting granules	Wulingsan co-decoction granules	Wulingsan co-decoction granules, Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment.
Simulant group: Simulant of granular dosage form	Wulingsan granule simulant	Granule simulant, the composition is Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day. Take 12 weeks as a course of treatment.

Primary Outcome Measures

Name	Time	Method
Analysis of body mass index changes in 12 weeks	12 weeks	Measure and record the patient's BMI before and after treatment
Analysis of changes in waist-to-hip ratio at 12 weeks	12 weeks	Measure and record the waist-to-hip ratio of the patient before and after treatment

Secondary Outcome Measures

Name	Time	Method
Improvement of the conversion score of phlegm-damp constitution judgment	12 weeks	To study the improvement of the conversion score of phlegm-damp constitution before and after treatment
Lipid Index	4 weeks，8 weeks，12 weeks	Investigate the changes in triglycerides, high-density lipoprotein cholesterol, cholesterol and low-density lipoprotein cholesterol during treatment
Fasting blood glucose index	4 weeks，8 weeks，12 weeks	Investigate changes in fasting blood glucose during treatment
2h blood glucose after meal	4 weeks，8 weeks，12 weeks	Investigate changes in 2h blood glucose after meal during treatment
HOMAA insulin resistance index	12 weeks	To investigate the changes of HOMAA insulin resistance index during treatment
Blood pressure index	4 weeks，8 weeks，12 weeks	Observe the changes in systolic and diastolic blood pressure during treatment
Inflammatory factors	12 weeks	Investigate the changes of hypersensitivity C-reactive protein and endotoxin during treatment