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Multi-center randomized clinical study of modified Zexie Decoction granule and decoction pieces in the treatment of postmenopausal metabolic syndrome

Multi-center randomized clinical study of modified Zexie Decoction granule and decoction pieces in the treatment of postmenopausal metabolic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064907
Enrollment
Unknown
Registered
2022-10-21
Start date
2022-10-22
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Postmenopausal metabolic syndrome

Interventions

Group 1 :Modified Zexie Decoction granules
Group 2:modified Zexie Decoction decoction pieces
Group 3:Modified Zexie Decoction granules placebo group

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincal Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
41 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of metabolic syndrome: 3 out of 5 items: TG >= 150 mg/dl (1.7 mmol/l); Hdl-c = 6.1 mmol/L or 2 hours after glucose loading >= 7.8 mmol/L; Elevated blood pressure: systolic blood pressure >= 130 mmHg or diastolic blood pressure >= 85 mmHg, or treated with antihypertensive drugs; Waist circumference >= 85 cm; 2. Women aged 41-60 years; 3. Meet the above diagnostic criteria, and the risk factors are in the following range: TC: 5.18-6.19 mmol/L; LDL-C: 3.37-4.12 mmol/L; TG: 1.70-2.25 mmol/L; Blood sugar level < 7.0 mmol/L; Systolic blood pressure <= 150 mmHg or diastolic blood pressure <= 95 mmhg; BMI <= 35 4. Patients with cardiovascular risk less than 10% in 10 years (using China-PAR risk assessment calculator); 5. TCM syndrome differentiation belongs to qi deficiency and dampness stagnation syndrome; 6. Climacteric syndrome kupperman index (ki) < 15; 7. No other drugs for the treatment of metabolic syndrome have been used in the past 4 weeks; No hormone therapy, selective estrogen receptor modulators, aromatase inhibitors, soybean extracts or herbs have been used; 8. Voluntary and capable of signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary dyslipidemia and familial hypercholesterolemia or secondary hypertension; 2. Patients with unstable angina pectoris, acute myocardial infarction, coronary stent implantation or coronary artery bypass surgery are at high risk of coronary heart disease; 3. Patients with a 10-year cardiovascular risk >= 10%(using china-PAR Risk Assessment Calculator); 4. Patients with type 1 diabetes with a history of diabetes > 10 years and concomitant kidney disease or other cardiovascular disease risk factors; 5. Patients with carotid artery stenosis, transient ischemic attack, acute stroke and peripheral vascular disease; 6. Patients with severe liver and renal insufficiency, hematopoietic system, malignant tumors and other serious primary diseases; 7. Psychiatric patients (schizophrenia, mania, paranoid psychosis and depression with significant suicidal tendencies); 8. Patients addicted to alcohol or other related products; 9. Patients who has participated in phase I and II clinical trials within the past 6 months or has participated in phase III and IV clinical trials within 3 months; 10. Patients with allergic constitution, etc.

Design outcomes

Primary

MeasureTime frame
glycometabolism;lipid metabolism;blood pressure;Physical examination (body weight, abdominal circumference, etc.);Body composition analysis;

Secondary

MeasureTime frame
carotid color ultrasonography;Homocysteine;C reactive protein;Metabonomics;gut microbiota;

Countries

China

Contacts

Public ContactGuangning Nie

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincal Hospital of Chinese Medicine)

guangningnie@gzucm.edu.cn+86 13724078380

Outcome results

None listed

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