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Clinical trial study on the efficacy of red ginseng products in improving menopausal symptoms in women

Clinical trial study on the efficacy of red ginseng products in improving menopausal symptoms in women

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079570
Enrollment
Unknown
Registered
2024-01-06
Start date
2024-01-12
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Menopausal Syndrome

Interventions

Test group:Taking Red Ginseng Beverage

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Menopausal women aged 45-60 years old who have undergone perimenopause and a period of time after perimenopause; 2. FSH (Follicle stimulating hormone) = 30 mIU/mL; 3. Individuals with a KI (kupperman Index) score higher than 25 and at least two of the following symptoms (insomnia, irritability, depression, fatigue) in the KI questionnaire are abnormal; 4. Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Women with a body mass index (BMI) exceeding 30kg/m2; 2. Women who have taken female hormone or similar hormone preparations within three months; 3. People with endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or breast diseases, and sex hormone related diseases; 4. Women with a history of cancer or other illnesses; 5. Patients undergoing hysterectomy; 6. Women who have experienced severe migraines, thromboembolism, cerebrovascular disease, myocardial infarction within the past year, and have been diagnosed with angina or have undergone coronary artery surgery; 7. Those who take medication related to hyperlipidemia or cardiovascular disease within three months; 8. Women who suffer from severe mental illnesses such as depression and anxiety, or are taking psychiatric and neurological related medications such as antidepressants and sleeping pills; 9. Those who take or inject treatment drugs due to abnormal uterine bleeding and related diseases after menopause; 10. Hypertensive patients with blood pressure higher than 160/100mmHg; 11. Diabetes patients with uncontrolled blood sugar (fasting blood sugar above 180mg/dL or drug use resumed due to diabetes within 3 months); 12. TSH at 0.1µU/mL below or 10µU/mL above Thyroid disease patients; 13. Abusers of drugs or alcohol; 14. When ALT or AST exceeds three times the normal upper limit value of the research institution; 15. When the serum Creatinine exceeds twice the normal upper limit value of the research institution; 16. Those who have used thyroid hormone preparations, Clonidine, anticoagulants, or antithrombotic agents within three months; 17. Those who take female menopause related medical products or health functional foods (vitamins and antioxidant products, fatigue related products, blood lipid and cardiovascular health related products, etc.) within one month; 18. Those who have taken human red ginseng related products within three months; 19. People who are taking osteoporosis treatment agents such as bisphosphonate preparations; 20. Vegetarians; 21. Patients with endometrial thickness>7mm; 22. The research leader believes that it is not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
NO;endothelial Nitric Oxide Synthase;Endothelin-1;Kupperman index;

Secondary

MeasureTime frame
Four items of blood lipid;Malondialdehyde;Superoxide dismutase;Glutathione peroxidase;Cortisol;Phosphate creatine kinase;Blood lactate;Beck depression inventory;Athens Insomnia Scale;

Countries

China

Contacts

Public ContactLi Yanling

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

kangaotech@aliyun.com+86 132 1207 0197

Outcome results

None listed

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