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Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Primary Purpose

Anxiety, Menopause

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xiangshao Granules
Xiangshao Granules Placebo
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Province Maternity & Child Health Hospital
  • Peking Union Medical College Hospital
  • Chongqing Health Center for Women and Children
  • Gansu Provincial Maternity and Child-care Hospital
  • Cangzhou People's Hospital
  • Second Hospital of Hebei Medical University
  • The First Affiliated Hospital of Henan University
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University
  • Second Xiangya Hospital of Central South University
  • Jiangsu Province Hospital of Chinese Medicine
  • Taizhou People's Hospital
  • Zhangjiagang First People's Hospital
  • Jiangxi Maternal and Child Health Hospital
  • Affiliated Zhongshan Hospital of Dalian University
  • Liaocheng People's Hospital
  • Chengdu Women's and Children's Central Hospital
  • School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
  • Tianjin Hospital of ITCWM Nankai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xiangshao Granules

Xiangshao Granules Placebo

Arm Description

dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks

dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SAS scores change (%)
% change in SAS scores after 4 weeks of treatment compared with baseline scores
Kupperman scores change (%)
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores
Kupperman scores change (%)
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores
Self-rating Depression Scale (SDS) scores change (%)
% change in SDS scores after 4 weeks of treatment compared with baseline scores
SDS scores change (%)
% change in SDS scores after 8 weeks of treatment compared with baseline scores
serum Follicle Stimulating Hormone (FSH) level
change in serum FSH level after 4 weeks of treatment compared with baseline
serum FSH level
change in serum FSH level after 8 weeks of treatment compared with baseline
serum estradiol (E2) level
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline
serum estradiol (E2) level
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline
gastrointestinal symptom score (GIS) change (%)
% change in GIS after 4 weeks of treatment compared with baseline scores
gastrointestinal symptom score (GIS) change (%)
% change in GIS after 8 weeks of treatment compared with baseline scores

Full Information

First Posted
August 10, 2021
Last Updated
December 22, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05003336
Brief Title
Effects of Xiangshao Granules on Anxiety in Menopausal Women.
Official Title
Effects of Xiangshao Granules on Anxiety in Menopausal Women: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xiangshao Granules
Arm Type
Experimental
Arm Description
dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks
Arm Title
Xiangshao Granules Placebo
Arm Type
Placebo Comparator
Arm Description
dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Xiangshao Granules
Intervention Description
dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Xiangshao Granules Placebo
Intervention Description
Xiangshao Granules Placebo
Primary Outcome Measure Information:
Title
Self-rating Anxiety Scale (SAS) scores change (%)
Description
% change in SAS scores after 8 weeks of treatment compared with baseline scores
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
SAS scores change (%)
Description
% change in SAS scores after 4 weeks of treatment compared with baseline scores
Time Frame
4 weeks
Title
Kupperman scores change (%)
Description
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores
Time Frame
4 weeks
Title
Kupperman scores change (%)
Description
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores
Time Frame
8 weeks
Title
Self-rating Depression Scale (SDS) scores change (%)
Description
% change in SDS scores after 4 weeks of treatment compared with baseline scores
Time Frame
4 weeks
Title
SDS scores change (%)
Description
% change in SDS scores after 8 weeks of treatment compared with baseline scores
Time Frame
8 weeks
Title
serum Follicle Stimulating Hormone (FSH) level
Description
change in serum FSH level after 4 weeks of treatment compared with baseline
Time Frame
4 weeks
Title
serum FSH level
Description
change in serum FSH level after 8 weeks of treatment compared with baseline
Time Frame
8 weeks
Title
serum estradiol (E2) level
Description
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline
Time Frame
4 weeks
Title
serum estradiol (E2) level
Description
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline
Time Frame
8 weeks
Title
gastrointestinal symptom score (GIS) change (%)
Description
% change in GIS after 4 weeks of treatment compared with baseline scores
Time Frame
4 weeks
Title
gastrointestinal symptom score (GIS) change (%)
Description
% change in GIS after 8 weeks of treatment compared with baseline scores
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Chen
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Province Maternity & Child Health Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
010
Country
China
Facility Name
Chongqing Health Center for Women and Children
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Gansu Provincial Maternity and Child-care Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Cangzhou People's Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
Second Hospital of Hebei Medical University
City
Shijiangzhuang
State/Province
Hebei
Country
China
Facility Name
The First Affiliated Hospital of Henan University
City
Kaifeng
State/Province
Henan
Country
China
Facility Name
Zhengzhou Central Hospital Affiliated to Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
Country
China
Facility Name
Zhangjiagang First People's Hospital
City
Zhangjiagang
State/Province
Jiangsu
ZIP/Postal Code
0512
Country
China
Facility Name
Jiangxi Maternal and Child Health Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
Chengdu Women's and Children's Central Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Hospital of ITCWM Nankai Hospital
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

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Effects of Xiangshao Granules on Anxiety in Menopausal Women.

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