NCT05003336

Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Effects of Xiangshao Granules on Anxiety in Menopausal Women: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Symptoms of anxiety are prevalent during the menopausal transition and early postmenopause. These symptoms are mainly improved by anti-anxiety agents, which are associated with some adverse effects including dizziness, sleepiness, and constipation and not all patients respond to currently available pharmacological treatments, thus novel agents with fewer side effects are needed. Some studies have shown that traditional Chinese medicine can alleviate menopausal symptoms safely and economically, and improve quality of life. Xiangshao granules reportedly have good curative effects on menopausal symptoms and premenstrual syndrome and exhibit good safety. This study aim to evaluate the efficacy and safety of Xiangshao granule in improving anxiety state of women with menopause syndrome.

Conditions

• Anxiety
• Menopause

Interventions

Type	Name	Description
DRUG	Xiangshao Granules	dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
DRUG	Xiangshao Granules Placebo	Xiangshao Granules Placebo

Timeline

• Start date: 2021-12-23
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2021-08-12
• Last updated: 2022-12-27

Locations

18 sites across 1 country: China