Perimenopausal symptoms
Conditions
Interventions
Treatment group:Standardized lifestyle intervention+a standardised botanical compound (Dachao Reju28) containing Syzygium aromaticum, Sophora japonica, and Dioscorea opposita extracts
Control group:Standardized lifestyle intervention
Sponsors
Sir Run Run Hospital, Nanjing Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following requirements for enrolment: 1. Perimenopausal women aged 40–65 years classified according to the Stages of Reproductive Aging Workshop +10 (STRAW+10) criteria. 2. Presence of any of the following symptoms for = 2 consecutive weeks: (1)Vasomotor symptoms (hot flushes, night sweats); (2)Sleep disturbances (sleep-onset insomnia, frequent awakening, non-restorative sleep); (3)Fatigue or asthenia; (4)Mood disorders (irritability, anxiety, tension, low mood, loneliness, heightened sensitivity); (5)Somatic complaints (chest tightness, dyspnoea, palpitations, myalgia/arthralgia, globus sensation, paraesthesia, etc.). 3.Modified Kupperman Index score >= 15. 4.Willingness to adhere to the diet and exercise protocol, and signed written informed consent.
Exclusion criteria
Exclusion criteria: Participants are excluded if any of the following apply: 1.Acute infectious illness. 2.Gynaecological malignancy or benign tumours requiring surgical intervention. 3.Bilateral oophorectomy or hysterectomy. 4.Use of sex-hormone therapy within 3 months prior to screening. 5. History of anxiety, depression, or other psychiatric disorders. 6. Severe cardiac, cerebral, hepatic, or thyroid disease. 7.Medical condition precluding physical exercise. 8. Pregnancy or lactation. 9.Any condition that, in the investigator’s opinion, renders the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Index(KMI);Sex-hormone profile; | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopause-Specific Quality of Life questionnaire (MENQOL);Pittsburgh Sleep Quality Index (PSQI);Positive and Negative Affect Schedule (PANAS);Urinalysis;Anti-Müllerian hormone (AMH);Serotonin;C-terminal telopeptide of type I collagen (CTX);Serum tartrate-resistant acid phosphatase (TRAP-5b);Serum osteocalcin;Gut microbiota profiling;Body-composition analysis; | — |
Countries
China
Contacts
Public ContactYu Liu
Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed