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

Jiangsu Famous Medical Technology

Status and phase: Unknown; Phase 4

Conditions: Metabolic Syndrome

Treatments: Drug: Wuling Powder; Drug: Wulingsan single decoction granules; Drug: Wulingsan granule simulant; Drug: Wulingsan co-decoction granules

Study type: Interventional

Funder types: Industry

Identifiers

NCT04812236

FM-P8-2018052801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 4 patient groups, including a placebo group

Single decoction group: Wulingsan single decoction granules

Experimental group

Description:

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.

Treatment:

Drug: Wulingsan single decoction granules

Co-decocting group: Wulingsan co-decocting granules

Other group

Description:

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.

Treatment:

Drug: Wulingsan co-decoction granules

Powder group: Wuling powder powder

Other group

Description:

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.

Treatment:

Drug: Wuling Powder

Simulant group: Simulant of granular dosage form

Placebo Comparator group

Description:

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.

Treatment:

Drug: Wulingsan granule simulant