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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: Wulingsan single decoction granules; Drug: Wulingsan co-decoction granules; Drug: Wuling Powder; Drug: Wulingsan granule simulant

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 Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lu Shu, PhD; Phone Number: 86-13961701999; Email: Lushu@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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
OTHER: 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.	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
OTHER: 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.	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
PLACEBO_COMPARATOR: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analysis of body mass index changes in 12 weeks	Measure and record the patient's BMI before and after treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Fasting blood glucose index	Investigate changes in fasting blood glucose during treatment	4 weeks，8 weeks，12 weeks
2h blood glucose after meal	Investigate changes in 2h blood glucose after meal during treatment	4 weeks，8 weeks，12 weeks
HOMAA insulin resistance index	To investigate the changes of HOMAA insulin resistance index during treatment	12 weeks
Blood pressure index	Observe the changes in systolic and diastolic blood pressure during treatment	4 weeks，8 weeks，12 weeks
Inflammatory factors	Investigate the changes of hypersensitivity C-reactive protein and endotoxin during treatment	12 weeks

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (ACTUAL): March 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: FM-P8-2018052801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No