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

NCT05003336 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 4
Status	UNKNOWN
Enrolment	360
Start date	2021-12-23
Completion	2023-06

Conditions

• Anxiety
• Menopause

Interventions

• Xiangshao Granules
• Xiangshao Granules Placebo

Primary outcomes

• Self-rating Anxiety Scale (SAS) scores change (%) — 8 weeks
  % change in SAS scores after 8 weeks of treatment compared with baseline scores

Countries

China