Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Last updated: December 22, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Menopause

Panic Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT05003336
XSKL20200422
  • Ages 40-65
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • meet the diagnostic criteria for menopause syndrome (age 40-65 years, being in themenopausal transition stage or postmenopausal stage determined according to the 2011Stages 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, andagrees to follow all study requirements. The investigator consider the subject able tocomplete the study.

Exclusion

Exclusion Criteria:

  • history of allergy or sensitivity to investigational product.
  • currently or historically taking medication or psychotherapy for menopause anxiety inthe past 4 weeks, including but not limited to estrogens, oestrogen-like hormone,Chinese medicine or health care products used to relieve anxiety (such as soyisoflavones, vitamin E, black cohosh), anti-anxiety agents, antidepressants, moodstabilizers, sedatives.
  • anxiety or other psychiatric disease unrelated to menopause (eg., currently orpreviously diagnosed as major depression, acute panic disorder, obsessive-compulsivedisorder, phobia, hypochondria, mood disorder or schizophrenia or psychiatric diseasescaused by other psychoactive substances or organic diseases), anxiety symptoms causedby 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 heartdisease, severe hypertension [sbp≥180mmHg and/or dbp≥110mmHg] or pheochromocytoma).
  • definite diagnosis of endometrial cancer, cervical cancer, ovarian cancer and othergynecological malignancies, as well as breast cancer.
  • severe liver or kidney diseases (eg., alanine aminotransferase[ALT]/aspartateaminotransferase[AST]/serum creatinine[Scr] levels 2 times greater than the upperlimit 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 touse reliable contraceptive methods throughout the study period.
  • other reasons the investigator consider the patient may not be suitable for the study.

Study Design

Total Participants: 360
Study Start date:
December 23, 2021
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Anhui Province Maternity & Child Health Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 010
    China

    Site Not Available

  • Chongqing Health Center for Women and Children

    Chongqing, Chongqing
    China

    Site Not Available

  • Gansu Provincial Maternity and Child-care Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • Cangzhou People's Hospital

    Cangzhou, Hebei
    China

    Site Not Available

  • Second Hospital of Hebei Medical University

    Shijiangzhuang, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University

    Kaifeng, Henan
    China

    Site Not Available

  • Zhengzhou Central Hospital Affiliated to Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu
    China

    Site Not Available

  • Taizhou People's Hospital

    Taizhou, Jiangsu
    China

    Site Not Available

  • Zhangjiagang First People's Hospital

    Zhangjiagang, Jiangsu 0512
    China

    Site Not Available

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning
    China

    Site Not Available

  • Affiliated Hospital of Shandong University of TCM

    Jinan, Shandong
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng, Shandong
    China

    Site Not Available

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan
    China

    Site Not Available

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

    Chengdu, Sichuan
    China

    Site Not Available

  • Tianjin Hospital of ITCWM Nankai Hospital

    Tianjin, Tianjin
    China

    Site Not Available

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