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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
Xiangshao Granules Placebo
Anhui Province Maternity & Child Health Hospital
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing Health Center for Women and Children
Chongqing, Chongqing Municipality, China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Second Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China
...and 8 more locations
Self-rating Anxiety Scale (SAS) scores change (%)
% change in SAS scores after 8 weeks of treatment compared with baseline scores
Time frame: 8 weeks
SAS scores change (%)
% change in SAS scores after 4 weeks of treatment compared with baseline scores
Time frame: 4 weeks
Kupperman scores change (%)
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores
Time frame: 4 weeks
Kupperman scores change (%)
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores
Time frame: 8 weeks
Self-rating Depression Scale (SDS) scores change (%)
% change in SDS scores after 4 weeks of treatment compared with baseline scores
Time frame: 4 weeks
SDS scores change (%)
% change in SDS scores after 8 weeks of treatment compared with baseline scores
Time frame: 8 weeks
serum Follicle Stimulating Hormone (FSH) level
change in serum FSH level after 4 weeks of treatment compared with baseline
Time frame: 4 weeks
serum FSH level
change in serum FSH level after 8 weeks of treatment compared with baseline
Time frame: 8 weeks
serum estradiol (E2) level
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline
Time frame: 4 weeks
serum estradiol (E2) level
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline
Time frame: 8 weeks
gastrointestinal symptom score (GIS) change (%)
% change in GIS after 4 weeks of treatment compared with baseline scores
Time frame: 4 weeks
gastrointestinal symptom score (GIS) change (%)
% change in GIS after 8 weeks of treatment compared with baseline scores
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.