Phase
Condition
Menopause
Panic Disorders
Mood Disorders
Treatment
N/AClinical Study ID
Ages 40-65 Female
Study Summary
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
Connect with a study center
Anhui Province Maternity & Child Health Hospital
Hefei, Anhui
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, Beijing 010
ChinaSite Not Available
Chongqing Health Center for Women and Children
Chongqing, Chongqing
ChinaSite Not Available
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu
ChinaSite Not Available
Cangzhou People's Hospital
Cangzhou, Hebei
ChinaSite Not Available
Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei
ChinaSite Not Available
The First Affiliated Hospital of Henan University
Kaifeng, Henan
ChinaSite Not Available
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan
ChinaSite Not Available
Second Xiangya Hospital of Central South University
Changsha, Hunan
ChinaSite Not Available
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu
ChinaSite Not Available
Taizhou People's Hospital
Taizhou, Jiangsu
ChinaSite Not Available
Zhangjiagang First People's Hospital
Zhangjiagang, Jiangsu 0512
ChinaSite Not Available
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi
ChinaSite Not Available
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
ChinaSite Not Available
Affiliated Hospital of Shandong University of TCM
Jinan, Shandong
ChinaSite Not Available
Liaocheng People's Hospital
Liaocheng, Shandong
ChinaSite Not Available
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
ChinaSite Not Available
School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan
ChinaSite Not Available
Tianjin Hospital of ITCWM Nankai Hospital
Tianjin, Tianjin
ChinaSite Not Available

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