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COMPLETED
NCT05003336
PHASE4

Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2021-12-23

Completion Date

2023-06-08

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

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

Locations (18)

Anhui Province Maternity & Child Health Hospital

Hefei, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Chongqing Health Center for Women and Children

Chongqing, Chongqing Municipality, China

Gansu Provincial Maternity and Child-care Hospital

Lanzhou, Gansu, China

Cangzhou People's Hospital

Cangzhou, Hebei, China

Second Hospital of Hebei Medical University

Shijiangzhuang, Hebei, China

The First Affiliated Hospital of Henan University

Kaifeng, Henan, China

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Taizhou People's Hospital

Taizhou, Jiangsu, China

Zhangjiagang First People's Hospital

Zhangjiagang, Jiangsu, China

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Tianjin Hospital of ITCWM Nankai Hospital

Tianjin, Tianjin Municipality, China