Effects of Xiangshao Granules on Anxiety in Menopausal Women.
- Conditions
- AnxietyMenopause
- Interventions
- Drug: Xiangshao Granules Placebo
- Registration Number
- NCT05003336
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 360
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xiangshao Granules Placebo 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 Xiangshao Granules Xiangshao Granules dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks
- Primary Outcome Measures
Name Time Method Self-rating Anxiety Scale (SAS) scores change (%) 8 weeks % change in SAS scores after 8 weeks of treatment compared with baseline scores
- Secondary Outcome Measures
Name Time Method serum FSH level 8 weeks change in serum FSH level after 8 weeks of treatment compared with baseline
SAS scores change (%) 4 weeks % change in SAS scores after 4 weeks of treatment compared with baseline scores
SDS scores change (%) 8 weeks % change in SDS scores after 8 weeks of treatment compared with baseline scores
gastrointestinal symptom score (GIS) change (%) 8 weeks % change in GIS after 8 weeks of treatment compared with baseline scores
serum Follicle Stimulating Hormone (FSH) level 4 weeks change in serum FSH level after 4 weeks of treatment compared with baseline
serum estradiol (E2) level 8 weeks change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline
Kupperman scores change (%) 8 weeks % change in Kupperman scores after 8 weeks of treatment compared with baseline scores
Self-rating Depression Scale (SDS) scores change (%) 4 weeks % change in SDS scores after 4 weeks of treatment compared with baseline scores
Trial Locations
- Locations (18)
The First Affiliated Hospital of Henan University
🇨🇳Kaifeng, Henan, China
Anhui Province Maternity & Child Health Hospital
🇨🇳Hefei, Anhui, China
Chongqing Health Center for Women and Children
🇨🇳Chongqing, Chongqing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Gansu Provincial Maternity and Child-care Hospital
🇨🇳Lanzhou, Gansu, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Jiangsu Province Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
🇨🇳Chengdu, Sichuan, China
Cangzhou People's Hospital
🇨🇳Cangzhou, Hebei, China
Second Hospital of Hebei Medical University
🇨🇳Shijiangzhuang, Hebei, China
Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhangjiagang First People's Hospital
🇨🇳Zhangjiagang, Jiangsu, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Chengdu Women's and Children's Central Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Hospital of ITCWM Nankai Hospital
🇨🇳Tianjin, Tianjin, China