NCT06074809

RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

Clinical Trial on the Treatment of Menopausal Syndrome With Chinese Medicine Gui-zhi-fu-ling-wan With Variation and the Mechanism of Anti-inflammation and Body Surface Temperature Distribution

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded, randomized, placebo-controlled clinical trial. Subjects will be randomly assigned to the treatment group (Modified Guizhi Fuling granules) or placebo group (Placebo granules) for 8 weeks. Outcomes will be measured at week 8 and week 12.

Detailed description

Menopausal syndrome is a series of symptoms caused by ovarian follicles degeneration that occurs before or after menopause. These symptoms include central nervous system-related disorders (such as hot flashes, insomnia, depression, anxiety, etc.); metabolic, weight, cardiovascular and musculoskeletal changes; urogenital and skin atrophy; and sexual dysfunction. Some previous studies have investigated the possibilities of using traditional Chinese medicine (TCM) for the treatment of menopausal syndrome. However, due to the limitations of previous clinical research, more evidence is required to support the efficacy of TCM treatment. Therefore, we propose to conduct a randomized, double-blinded, placebo-controlled clinical trial here, with the hope of objectively assessing the efficacy and safety of using TCM to treat menopausal syndrome.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Modified Guizhi Fuling granules	Modified Guizhi Fuling granules will be orally administered to patients in the TCM treatment group twice a day throughout the treatment period, which lasts for 8 weeks.
OTHER	Placebo	Placebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-10-31
• Completion: 2026-01-31
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: Hong Kong