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

NCT ID: NCT04812236

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-05-01

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Single decoction group: 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.

Group Type: EXPERIMENTAL

Wulingsan single decoction granules

Intervention Type: DRUG

Wulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water

Co-decocting group: Wulingsan co-decocting 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.

Group Type: OTHER

Wulingsan co-decoction granules

Intervention Type: DRUG

Wulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water

Powder group: Wuling powder 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.

Group Type: OTHER

Wuling Powder

Intervention Type: DRUG

Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water

Simulant group: Simulant of granular dosage form

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.

Group Type: PLACEBO_COMPARATOR

Wulingsan granule simulant

Intervention Type: DRUG

Wulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water

Interventions

Wulingsan single decoction granules

Wulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water

Intervention Type: DRUG

Wulingsan co-decoction granules

Wulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water

Intervention Type: DRUG

Wuling Powder

Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water

Intervention Type: DRUG

Wulingsan granule simulant

Wulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Famous Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lu Shu, PhD

Role: CONTACT

Lushu@medmail.com.cn

86-13961701999

Other Identifiers

FM-P8-2018052801

Identifier Type: -

Identifier Source: org_study_id