Effects of Xiangshao Granules on Anxiety in Menopausal Women.

December 22, 2022 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Province Maternity & Child Health Hospital
    • Beijing
      • Beijing, Beijing, China, 010
        • Peking Union Medical College Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Health Center for Women and Children
    • Gansu
      • Lanzhou, Gansu, China
        • Gansu Provincial Maternity and Child-care Hospital
    • Hebei
      • Cangzhou, Hebei, China
        • Cangzhou People's Hospital
      • Shijiangzhuang, Hebei, China
        • Second Hospital of Hebei Medical University
    • Henan
      • Kaifeng, Henan, China
        • The First Affiliated Hospital of Henan University
      • Zhengzhou, Henan, China
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
    • Hunan
      • Changsha, Hunan, China
        • Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital of Chinese Medicine
      • Taizhou, Jiangsu, China
        • Taizhou People's Hospital
      • Zhangjiagang, Jiangsu, China, 0512
        • Zhangjiagang First People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Maternal and Child Health Hospital
    • Liaoning
      • Dalian, Liaoning, China
        • Affiliated Zhongshan Hospital of Dalian University
    • Shandong
      • Liaocheng, Shandong, China
        • Liaocheng People's Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Women's and Children's Central Hospital
      • Chengdu, Sichuan, China
        • School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Hospital of ITCWM Nankai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • meet the diagnostic criteria for menopause syndrome (age 40-65 years, being in the menopausal transition stage or postmenopausal stage determined according to the 2011 Stages of Reproductive Aging Workshop +10 criteria).
  • 50 ≤ SAS scores ≤ 69.
  • improved Kupperman scores ≥16.
  • has an intact uterus and at least one ovary.
  • able and willing to participate in study and provide written informed consent, and agrees to follow all study requirements. The investigator consider the subject able to complete the study.

Exclusion Criteria:

  • history of allergy or sensitivity to investigational product.
  • currently or historically taking medication or psychotherapy for menopause anxiety in the past 4 weeks, including but not limited to estrogens, oestrogen-like hormone, Chinese medicine or health care products used to relieve anxiety (such as soy isoflavones, vitamin E, black cohosh), anti-anxiety agents, antidepressants, mood stabilizers, sedatives.
  • anxiety or other psychiatric disease unrelated to menopause (eg., currently or previously diagnosed as major depression, acute panic disorder, obsessive-compulsive disorder, phobia, hypochondria, mood disorder or schizophrenia or psychiatric diseases caused by other psychoactive substances or organic diseases), anxiety symptoms caused by stress, suicidal tendency, alcohol or drug dependence, etc.
  • having major depression as defined by a SDS score≥70 at screening.
  • systemic disease (eg., hypothyroidism/hyperthyroidism, unstable coronary heart disease, severe hypertension [sbp≥180mmHg and/or dbp≥110mmHg] or pheochromocytoma).
  • definite diagnosis of endometrial cancer, cervical cancer, ovarian cancer and other gynecological malignancies, as well as breast cancer.
  • severe liver or kidney diseases (eg., alanine aminotransferase[ALT]/aspartate aminotransferase[AST]/serum creatinine[Scr] levels 2 times greater than the upper limit of normal) or severe primary diseases in cardiovascular, cerebrovascular, liver, kidney and hematopoietic system.
  • participated in other clinical trials within the last 3 months.
  • lactating or pregnant women, or plan to become pregnant during study or not agree to use reliable contraceptive methods throughout the study period.
  • other reasons the investigator consider the patient may not be suitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Xiangshao Granules
dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks
Drug: Xiangshao Granules
dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
Placebo Comparator: Xiangshao Granules Placebo
dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks
Drug: Xiangshao Granules Placebo
Xiangshao Granules Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-rating Anxiety Scale (SAS) scores change (%)
Time Frame: 8 weeks
% change in SAS scores after 8 weeks of treatment compared with baseline scores
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAS scores change (%)
Time Frame: 4 weeks
% change in SAS scores after 4 weeks of treatment compared with baseline scores
4 weeks
Kupperman scores change (%)
Time Frame: 4 weeks
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores
4 weeks
Kupperman scores change (%)
Time Frame: 8 weeks
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores
8 weeks
Self-rating Depression Scale (SDS) scores change (%)
Time Frame: 4 weeks
% change in SDS scores after 4 weeks of treatment compared with baseline scores
4 weeks
SDS scores change (%)
Time Frame: 8 weeks
% change in SDS scores after 8 weeks of treatment compared with baseline scores
8 weeks
serum Follicle Stimulating Hormone (FSH) level
Time Frame: 4 weeks
change in serum FSH level after 4 weeks of treatment compared with baseline
4 weeks
serum FSH level
Time Frame: 8 weeks
change in serum FSH level after 8 weeks of treatment compared with baseline
8 weeks
serum estradiol (E2) level
Time Frame: 4 weeks
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline
4 weeks
serum estradiol (E2) level
Time Frame: 8 weeks
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline
8 weeks
gastrointestinal symptom score (GIS) change (%)
Time Frame: 4 weeks
% change in GIS after 4 weeks of treatment compared with baseline scores
4 weeks
gastrointestinal symptom score (GIS) change (%)
Time Frame: 8 weeks
% change in GIS after 8 weeks of treatment compared with baseline scores
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rong Chen, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XSKL20200422

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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