Effects of Xiangshao Granules on Anxiety in Menopausal Women.

NCT05003336 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-12-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Rong Chen · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2023-03-31
Completion
2023-06-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003336 on ClinicalTrials.gov