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Real-world clinical study on Yishen Tiaozhi Formula for treating menopausal dyslipidemia

Real-world clinical evaluation of Yishen Tiaozhi Formula for menopausal dyslipidemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000530
Enrollment
Unknown
Registered
2026-03-13
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

menopausal dyslipidemia

Interventions

Traditional Chinese Medicine Group:Yishen Tiaozhi Formula (Cuscuta chinensis, Angelica sinensis, Gynostemma pentaphyllum, Nelumbo nucifera leaf, Gastrodia elata, Monascus purpureus) for pure herbal tr
Western Medicine Group:Standardized Menopause Hormone Therapy (MHT) or lipid-regulating treatment

Sponsors

Dongzhimen Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1)Females aged 45-55; 2) Meeting perimenopause diagnosis (WHO 1994 definition: period from onset of menopausal signs until 1 year after final menstruation, typically 45-55 years) with FSH >10 IU/L; 3) Dyslipidemia diagnosis (TC=5.2mmol/L, TG=1.7mmol/L, LDL-C>3.4mmol/L, non-HDL-C=4.1mmol/L, or HDL-C<1.0mmol/L); 4) No participation in other clinical trials within 1 month; 5) No lipid-regulating/hormone therapy or Chinese herbs within 1 month; 6) Compliance with treatment and follow-up; 7) Signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1)Intolerance/allergy to study drugs; 2) Severe hepatic/renal dysfunction, malignancies, severe systemic/infectious diseases; 3) Endocrine disorders (diabetes/thyroid diseases); 4) Cardiovascular diseases; 5) Thrombotic disorders; 6) Unexplained vaginal bleeding; 7) Mental/neurological disorders; 8) Pregnancy/lactation; 9) TG>5.65mmol/L or LDL-C>4.9mmol/L.

Design outcomes

Primary

MeasureTime frame
Lipid Profile;

Secondary

MeasureTime frame
Menopausal Quality of Life Scale;Kupperman Score;Sex hormone indicators;Weight;BMI;

Countries

China

Contacts

Public ContactLiu Xiaoli

China Academy of Chinese Medicine

synia76liu@126.com13581829162

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026