Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Anxiety Clinical Trial

Official title:

Effects of Xiangshao Granules on Anxiety in Menopausal Women: A Multicenter, Randomized, Double-blind, Placebo-controlled Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05003336
• Other study ID #: XSKL20200422
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 23, 2021
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Menopause

Intervention

Drug:
• Xiangshao Granules
dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
• Xiangshao Granules Placebo
Xiangshao Granules Placebo

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Cangzhou People's Hospital	Cangzhou	Hebei
China	Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan
China	School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan
China	Chongqing Health Center for Women and Children	Chongqing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	Anhui Province Maternity & Child Health Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Henan University	Kaifeng	Henan
China	Gansu Provincial Maternity and Child-care Hospital	Lanzhou	Gansu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Jiangxi Maternal and Child Health Hospital	Nanchang	Jiangxi
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Second Hospital of Hebei Medical University	Shijiangzhuang	Hebei
China	Taizhou People's Hospital	Taizhou	Jiangsu
China	Tianjin Hospital of ITCWM Nankai Hospital	Tianjin	Tianjin
China	Zhangjiagang First People's Hospital	Zhangjiagang	Jiangsu
China	Zhengzhou Central Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-rating Anxiety Scale (SAS) scores change (%)	% change in SAS scores after 8 weeks of treatment compared with baseline scores	8 weeks
Secondary	SAS scores change (%)	% change in SAS scores after 4 weeks of treatment compared with baseline scores	4 weeks
Secondary	Kupperman scores change (%)	% change in Kupperman scores after 4 weeks of treatment compared with baseline scores	4 weeks
Secondary	Kupperman scores change (%)	% change in Kupperman scores after 8 weeks of treatment compared with baseline scores	8 weeks
Secondary	Self-rating Depression Scale (SDS) scores change (%)	% change in SDS scores after 4 weeks of treatment compared with baseline scores	4 weeks
Secondary	SDS scores change (%)	% change in SDS scores after 8 weeks of treatment compared with baseline scores	8 weeks
Secondary	serum Follicle Stimulating Hormone (FSH) level	change in serum FSH level after 4 weeks of treatment compared with baseline	4 weeks
Secondary	serum FSH level	change in serum FSH level after 8 weeks of treatment compared with baseline	8 weeks
Secondary	serum estradiol (E2) level	change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline	4 weeks
Secondary	serum estradiol (E2) level	change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline	8 weeks
Secondary	gastrointestinal symptom score (GIS) change (%)	% change in GIS after 4 weeks of treatment compared with baseline scores	4 weeks
Secondary	gastrointestinal symptom score (GIS) change (%)	% change in GIS after 8 weeks of treatment compared with baseline scores	8 weeks