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Clinical study of spleen-strengthening and lipid-lowering formula for the treatment of patients with metabolic syndrome with phlegm-dampness internalization type

Clinical study of JPJZP in treating patients with metabolic syndrome with phlegm-dampness internalization type

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000999
Enrollment
Unknown
Registered
2025-05-16
Start date
2024-10-17
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic syndrome

Interventions

experimental group:Traditional Chinese Medicine JPJZP + Western standard treatment group

Sponsors

Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria: 1.1 Western medical diagnostic criteria with reference to the 2023 edition of the Expert Consensus on the Management of Metabolic Syndrome 4 items meet 2 or more: (1) central obesity: waist circumference =90 cm for men and =85 cm for women (2) dyslipidemia: triglycerides =1.7 mmol/L or undergoing lipid-lowering therapy (3) dysglycemia: fasting blood glucose =6.1 mmol/L or undergoing glucose-lowering (4) Hypertension: systolic blood pressure =130 mmHg or diastolic blood pressure =85 mmHg or receiving antihypertensive treatment. 1.2 Diagnostic criteria of Chinese medicine referring to the 2023 edition of the Metabolic Syndrome Diagnosis and Treatment Guidelines the identification and typing criteria of phlegm-dampness embedded syndrome in Chinese medicine: Symptoms: obesity chest and epigastric constriction limbs heavy and heavy or even aching sleepiness sleepy dull face sticky mouth pale tongue fat tongue thick or greasy moss and slippery pulse. The diagnosis of this syndrome can be confirmed if the tongue and pulse of the above symptoms are consistent with the other two symptoms. Inclusion criteria: 1) Meet the following diagnostic criteria of Chinese and Western medicine; 2) Age: 18-85 years old; 3) Complete clinical medical records; 4) Voluntary participation in this research project active cooperation with the research task deployment and did not take other traditional Chinese medicine formulas or medicines except for the formula for strengthening the spleen and lowering lipids and signed the informed consent form.

Exclusion criteria

Exclusion criteria: Patients with unstable angina pectoris or acute myocardial infarction; 2) pregnant or lactating women; 3) patients with psychiatric diseases; 4) patients with high risk of hypertension; 5) patients with angina pectoris caused by coronary arteritis syphilitic aortitis hypertrophic cardiomyopathy congenital coronary artery anomalies; 6) patients with severe renal insufficiency respiratory failure hepatic failure and hyperthyroidism; 7) patients with poor compliance inability to adhere to the standardized treatment of western medicine and inability to cooperate with the examination; 8) patients who are taking other traditional Chinese medicine and patent medicines during the period of enrollment or need to take PPWF or cannot cooperate with the examination. Patients with poor adherence unable to insist on taking the formula for strengthening the spleen and lowering lipids unable to accept the standardized treatment of Western medicine unable to cooperate with the examination; (8) patients taking other traditional Chinese medicines and patent medicines during the period of enrollment and patients taking or needing to take medicines that will affect the PPAR and ApoE (e.g. statins fibrates bile hydrochloride acid exchangers PCSK9 inhibitors thiazolidinediones and GLP-1 agonists etc.); and (9) patients not meeting the clinical criteria of phlegm-dampness-insidious type; and Patients who do not meet the clinical symptoms and tongue and pulse manifestations of the phlegm-dampness internalization type; 10) Allergic constitution and those who are allergic to the drugs of the spleen-strengthening and lipid-lowering formula of this study.

Design outcomes

Primary

MeasureTime frame
triglyceride;BMI;Triglyceride Glucose Index;total cholesterol;high density lipoprotein cholesterol;low density lipoprotein cholesterol;glomerular filtration rate (GFR);

Secondary

MeasureTime frame
waist;weight;PPAR?;PPARa;PPARß;

Countries

China

Contacts

Public ContactQilan Chen

Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University

1469013813@qq.com13588750941

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026