Clinical trial NCT05003336: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anxiety
Menopause
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 360
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Self-rating Anxiety Scale (SAS) scores change (%)
timeFrame: 8 weeks
Secondary outcomes:
measure: SAS scores change (%)
timeFrame: 4 weeks
measure: Kupperman scores change (%)
timeFrame: 4 weeks
measure: Kupperman scores change (%)
timeFrame: 8 weeks
measure: Self-rating Depression Scale (SDS) scores change (%)
timeFrame: 4 weeks
measure: SDS scores change (%)
timeFrame: 8 weeks
measure: serum Follicle Stimulating Hormone (FSH) level
timeFrame: 4 weeks
measure: serum FSH level
timeFrame: 8 weeks
measure: serum estradiol (E2) level
timeFrame: 4 weeks
measure: serum estradiol (E2) level
timeFrame: 8 weeks
measure: gastrointestinal symptom score (GIS) change (%)
timeFrame: 4 weeks
measure: gastrointestinal symptom score (GIS) change (%)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Province Maternity & Child Health Hospital
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Health Center for Women and Children
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Maternity and Child-care Hospital
state: Gansu
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Shijiangzhuang
country: China
facility: Second Hospital of Hebei Medical University
state: Hebei
city: Kaifeng
country: China
facility: The First Affiliated Hospital of Henan University
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital Affiliated to Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou People's Hospital
state: Jiangsu
city: Zhangjiagang
country: China
facility: Zhangjiagang First People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Chengdu
country: China
facility: School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Hospital of ITCWM Nankai Hospital
state: Tianjin
Study officials:
affiliation: Peking Union Medical College Hospital
name: Rong Chen
role: PRINCIPAL_INVESTIGATOR
References: