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A multi-center randomized controlled trial study on the effects of Tiepi Fengdou Granules on nutrition and menopausal-related symptoms in menopausal women

A multi-center randomized controlled trial study on the effects of Tiepi Fengdou Granules on nutrition and menopausal-related symptoms in menopausal women

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077804
Enrollment
Unknown
Registered
2023-11-20
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

menopausal syndrome

Interventions

Control group:Bujiale 1mg + Dydrogesterone 5mg/day, continuous administration for 90 days
Experimental group 1:Tiepi Fengdou Granules (3g/pack), 2 packs/time, 3 times a day, for 90 days
Experimental group 2:Tiepi Fengdou Granules (3g/pack), 2 packs/time, 3 times a day, combined with Bujiale 1mg + Dydrogesterone 5mg/day, taken continuously for 90 days

Sponsors

Women's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female aged 40-65 years old; 2. Menopause for more than 12 months and pregnancy excluded, follicle-stimulating hormone >40U/L and estradiol <10-20pg/ml; 3. Have a uterus and at least one ovary; 4. Accompanied by vasomotor symptoms such as hot flashes or symptoms of autonomic nervous system dysfunction such as palpitations, dizziness, headache, insomnia, tinnitus, or psychiatric and neurological symptoms such as agitation, anxiety, low mood, depression, or vaginal dryness, dyspareunia, Women with recurrent vaginal infections, difficulty urinating, frequent urination, urgency and other urogenital symptoms, or osteoporosis; 5. Voluntarily participate and sign the consent form to enter clinical research.

Exclusion criteria

Exclusion criteria: 1. Those who have undergone artificial menopause due to uterine or bilateral ovary removal or other reasons, such as radiotherapy and chemotherapy; 2. Women who are using other drugs and treatments to relieve menopausal-related symptoms; 3. People with wind-cold-damp paralysis, those with warm-heat disease whose yin is not injured in the early stage, those with damp-warm disease whose dryness has not resolved, or those with spleen and stomach deficiency; 4. People who have experienced discomfort while taking Tiepi Fengdou.

Design outcomes

Primary

MeasureTime frame
Sex hormone test;Liver and kidney function tests;Thyroid function test;Ultrasound of uterus and breast;Vaginal microecology examination;

Countries

China

Contacts

Public ContactJianhong Zhou

Women's Hospital, Zhejiang University School of Medicine

zzjjhh@126.com+86 159 9000 8569

Outcome results

None listed

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