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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04812236
• Other study ID #: FM-P8-2018052801
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: January 2021
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Lu Shu, PhD
• Phone: 86-13961701999
• Email: Lushu[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: May 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of changes in waist-to-hip ratio at 12 weeks	Measure and record the waist-to-hip ratio of the patient before and after treatment	12 weeks
Primary	Analysis of body mass index changes in 12 weeks	Measure and record the patient's BMI before and after treatment	12 weeks
Secondary	Improvement of the conversion score of phlegm-damp constitution judgment	To study the improvement of the conversion score of phlegm-damp constitution before and after treatment	12 weeks
Secondary	Lipid Index	Investigate the changes in triglycerides, high-density lipoprotein cholesterol, cholesterol and low-density lipoprotein cholesterol during treatment	4 weeks,8 weeks,12 weeks
Secondary	Fasting blood glucose index	Investigate changes in fasting blood glucose during treatment	4 weeks,8 weeks,12 weeks
Secondary	2h blood glucose after meal	Investigate changes in 2h blood glucose after meal during treatment	4 weeks,8 weeks,12 weeks
Secondary	HOMAA insulin resistance index	To investigate the changes of HOMAA insulin resistance index during treatment	12 weeks
Secondary	Blood pressure index	Observe the changes in systolic and diastolic blood pressure during treatment	4 weeks,8 weeks,12 weeks
Secondary	Inflammatory factors	Investigate the changes of hypersensitivity C-reactive protein and endotoxin during treatment	12 weeks