Effects of Xiangshao Granules on Anxiety in Menopausal Women.

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Menopause

Intervention / Treatment
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* Drug: Xiangshao Granules
* Drug: Xiangshao Granules Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xiangshao Granules<br>dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks | Drug: Xiangshao Granules<br>* dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks<br>|
| Placebo Comparator: Xiangshao Granules Placebo<br>dissolve 1 sachet (4 g) of Xiangshao Granules placebo in water to be drank 3 times a day after meal for 8 weeks | Drug: Xiangshao Granules Placebo<br>* Xiangshao Granules Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-rating Anxiety Scale (SAS) scores change (%) | % change in SAS scores after 8 weeks of treatment compared with baseline scores | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAS scores change (%) | % change in SAS scores after 4 weeks of treatment compared with baseline scores | 4 weeks | 
| Kupperman scores change (%) | % change in Kupperman scores after 4 weeks of treatment compared with baseline scores | 4 weeks | 
| Kupperman scores change (%) | % change in Kupperman scores after 8 weeks of treatment compared with baseline scores | 8 weeks | 
| Self-rating Depression Scale (SDS) scores change (%) | % change in SDS scores after 4 weeks of treatment compared with baseline scores | 4 weeks | 
| SDS scores change (%) | % change in SDS scores after 8 weeks of treatment compared with baseline scores | 8 weeks | 
| serum Follicle Stimulating Hormone (FSH) level | change in serum FSH level after 4 weeks of treatment compared with baseline | 4 weeks | 
| serum FSH level | change in serum FSH level after 8 weeks of treatment compared with baseline | 8 weeks | 
| serum estradiol (E2) level | change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline | 4 weeks | 
| serum estradiol (E2) level | change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline | 8 weeks | 
| gastrointestinal symptom score (GIS) change (%) | % change in GIS after 4 weeks of treatment compared with baseline scores | 4 weeks | 
| gastrointestinal symptom score (GIS) change (%) | % change in GIS after 8 weeks of treatment compared with baseline scores | 8 weeks |