Влияние гранул Сяншао на тревогу у женщин в период менопаузы.
Влияние гранул Сяншао на тревогу у женщин в период менопаузы: многоцентровое рандомизированное двойное слепое плацебо-контролируемое исследование.
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
-
-
Anhui
-
Hefei, Anhui, Китай
- Anhui Province Maternity & Child Health Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Китай, 010
- Peking Union Medical College Hospital
-
-
Chongqing Municipality
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Chongqing, Chongqing Municipality, Китай
- Chongqing Health Center for Women and Children
-
-
Gansu
-
Lanzhou, Gansu, Китай
- Gansu Provincial Maternity and Child-care Hospital
-
-
Hebei
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Cangzhou, Hebei, Китай
- Cangzhou People's Hospital
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Shijiangzhuang, Hebei, Китай
- Second Hospital of Hebei Medical University
-
-
Henan
-
Kaifeng, Henan, Китай
- The First Affiliated Hospital of Henan University
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Zhengzhou, Henan, Китай
- Zhengzhou Central Hospital Affiliated to Zhengzhou University
-
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Hunan
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Changsha, Hunan, Китай
- Second Xiangya Hospital of Central South University
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-
Jiangsu
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Nanjing, Jiangsu, Китай
- Jiangsu Province Hospital of Chinese Medicine
-
Taizhou, Jiangsu, Китай
- Taizhou People's Hospital
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Zhangjiagang, Jiangsu, Китай, 0512
- Zhangjiagang First People's Hospital
-
-
Jiangxi
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Nanchang, Jiangxi, Китай
- Jiangxi Maternal and Child Health Hospital
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-
Liaoning
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Dalian, Liaoning, Китай
- Affiliated Zhongshan Hospital of Dalian University
-
-
Shandong
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Liaocheng, Shandong, Китай
- Liaocheng People's Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Китай
- Chengdu Women's and Children's Central Hospital
-
Chengdu, Sichuan, Китай
- School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
-
-
Tianjin Municipality
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Tianjin, Tianjin Municipality, Китай
- Tianjin Hospital of ITCWM Nankai Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Xiangshao Granules
dissolve 1 sachet (4 g) of Xiangshao Granules in water to be drank 3 times a day after meal for 8 weeks |
dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks |
|
Плацебо Компаратор: 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 Placebo |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Self-rating Anxiety Scale (SAS) scores change (%)
Временное ограничение: 8 weeks
|
% change in SAS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
SAS scores change (%)
Временное ограничение: 4 weeks
|
% change in SAS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Временное ограничение: 4 weeks
|
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Временное ограничение: 8 weeks
|
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
Self-rating Depression Scale (SDS) scores change (%)
Временное ограничение: 4 weeks
|
% change in SDS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
SDS scores change (%)
Временное ограничение: 8 weeks
|
% change in SDS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
serum Follicle Stimulating Hormone (FSH) level
Временное ограничение: 4 weeks
|
change in serum FSH level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum FSH level
Временное ограничение: 8 weeks
|
change in serum FSH level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
serum estradiol (E2) level
Временное ограничение: 4 weeks
|
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum estradiol (E2) level
Временное ограничение: 8 weeks
|
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Временное ограничение: 4 weeks
|
% change in GIS after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Временное ограничение: 8 weeks
|
% change in GIS after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Соавторы и исследователи
Следователи
- Главный следователь: Rong Chen, Peking Union Medical College Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- XSKL20200422
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .