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

NCT04812236 | Unknown Phase 4

• 1 other identifier: FM-P8-2018052801
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Improvement of the conversion score of phlegm-damp constitution judgment

  12 weeks

• Lipid Index

  4 weeks，8 weeks，12 weeks

• Fasting blood glucose index

  4 weeks，8 weeks，12 weeks

• 2h blood glucose after meal

  4 weeks，8 weeks，12 weeks

• HOMAA insulin resistance index

  12 weeks

Study Arms (4)

Single decoction group: Wulingsan single decoction granules

EXPERIMENTAL

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

Co-decocting group: Wulingsan co-decocting granules

OTHER

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

Powder group: Wuling powder powder

OTHER

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

Simulant group: Simulant of granular dosage form

PLACEBO COMPARATOR

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

Interventions

Wulingsan single decoction granules 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

Single decoction group: Wulingsan single decoction granules

Wulingsan co-decoction granules 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

Co-decocting group: Wulingsan co-decocting granules

Wuling Powder DRUG

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

Powder group: Wuling powder powder

Wulingsan granule simulant 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

Simulant group: Simulant of granular dosage form

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the diagnostic criteria of metabolic syndrome;
• TCM syndrome differentiation of spleen deficiency and dampness patients;
• Patients with phlegm-dampness constitution score\>30;
• Patients aged 18 to 70 years;
• Patients who have signed informed consent and are highly compliant.

You may not qualify if:

• Patients with hypertension, hyperglycemia, and hyperlipidemia caused by secondary metabolic syndrome (disease, drugs, surgery, etc.);
• Patients with severe primary diseases such as heart, liver, kidney, lung, brain, endocrine, hematopoietic system in the past or at the time of enrollment;
• Those who are confirmed to have acute coronary syndrome, malignant arrhythmia, and other serious heart diseases;
• Patients with co-infection, malignant tumors or mental illness;
• Patients with Cushing syndrome;
• Patients with allergies or allergies to this drug;
• Pregnant or breastfeeding women;
• Those who have adjusted hypoglycemic, lipid-lowering, antihypertensive drugs or taking weight-loss drugs within 1 month before enrollment.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Lu Shu, PhD

CONTACT

86-13961701999; Lushu@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 23, 2021
• Study Start: April 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: May 1, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-01