Effects of Xiangshao Granules on Anxiety in Menopausal Women.

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: Active, not recruiting
• Conditions: Anxiety; Menopause
• Intervention / Treatment: Drug: Xiangshao Granules; Drug: Xiangshao Granules Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Rong Chen, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID 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