A randomized controlled study on the treatment of perimenopausal syndrome with Jinfeng Pills combined with Femoston based on the NF-?B/IL-1ß/IL-18 pathway

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026001256

Enrollment

Unknown

Registered

2026-05-18

Start date

2026-01-26

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

Perimenopausal Syndrome

Interventions

Experimental group:Jinfeng Pills Fenmatong

Control group:Jinfeng Pill placebo Fenmatong

Eligibility

Sex/Gender

Female

Age

40 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Participants who meet the diagnostic criteria for perimenopausal syndrome in Western medicine and for kidney yang deficiency syndrome in Traditional Chinese Medicine; (2) Female participants aged 40 to 55 years (including 40 and 55 years old); (3) No contraindications for hormone therapy; (4) No history of hormone therapy in the past six months; (5) Able to complete questionnaires independently; (6) Voluntarily willing to participate in the trial and sign the informed consent form. All of the above conditions must be met simultaneously.

Exclusion criteria

Exclusion criteria: (1) Individuals with diseases that cause similar symptoms due to organic lesions of the genitourinary system, mental illness, hyperthyroidism, cardiovascular diseases, endometrial lesions, etc.; (2) Individuals with severe heart, liver, brain, kidney, or hematopoietic system diseases; (3) Individuals who have previously undergone ovarian or uterine removal; (4) Individuals with mental illness or cognitive impairments; (5) Individuals allergic to any component of Jinfeng Wan; (6) Individuals who have contraindications to the use of Flibanserin. Meeting any one of the above exclusion criteria is sufficient to prevent inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Efficacy Assessment of Traditional Chinese Medicine;Serum levels of IL-1ß, IL-18, TNF-a, and NF-?B;Serum FSH and E2 levels;Pre- and post-treatment scores of menopausal symptoms in women (modified Kupperman index), pre- and post-treatment scores of menopausal syndrome (traditional Chinese medicine) assessment scale, Pittsb;	—

Secondary

Measure	Time frame
Liver and kidney function;Complete Blood Count;	—

Countries

China

Contacts

Public ContactSun miao

The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

sunmiao82@163.com13704180319

Outcome results

None listed

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