Účinky Xiangshao granulí na úzkost u žen v menopauze.
Účinky granulí Xiangshao na úzkost u žen v menopauze: multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie.
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
Anhui
-
Hefei, Anhui, Čína
- Anhui Province Maternity & Child Health Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 010
- Peking Union Medical College Hospital
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Čína
- Chongqing Health Center for Women and Children
-
-
Gansu
-
Lanzhou, Gansu, Čína
- Gansu Provincial Maternity and Child-care Hospital
-
-
Hebei
-
Cangzhou, Hebei, Čína
- Cangzhou People's Hospital
-
Shijiangzhuang, Hebei, Čína
- Second Hospital of Hebei Medical University
-
-
Henan
-
Kaifeng, Henan, Čína
- The First Affiliated Hospital of Henan University
-
Zhengzhou, Henan, Čína
- Zhengzhou Central Hospital Affiliated to Zhengzhou University
-
-
Hunan
-
Changsha, Hunan, Čína
- Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína
- Jiangsu Province Hospital of Chinese Medicine
-
Taizhou, Jiangsu, Čína
- Taizhou People's Hospital
-
Zhangjiagang, Jiangsu, Čína, 0512
- Zhangjiagang First People's Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Čína
- Jiangxi Maternal and Child Health Hospital
-
-
Liaoning
-
Dalian, Liaoning, Čína
- Affiliated Zhongshan Hospital of Dalian University
-
-
Shandong
-
Liaocheng, Shandong, Čína
- Liaocheng People's Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Čína
- Chengdu Women's and Children's Central Hospital
-
Chengdu, Sichuan, Čína
- School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Čína
- Tianjin Hospital of ITCWM Nankai Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Komparátor placeba: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Self-rating Anxiety Scale (SAS) scores change (%)
Časové okno: 8 weeks
|
% change in SAS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
SAS scores change (%)
Časové okno: 4 weeks
|
% change in SAS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Časové okno: 4 weeks
|
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Časové okno: 8 weeks
|
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
Self-rating Depression Scale (SDS) scores change (%)
Časové okno: 4 weeks
|
% change in SDS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
SDS scores change (%)
Časové okno: 8 weeks
|
% change in SDS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
serum Follicle Stimulating Hormone (FSH) level
Časové okno: 4 weeks
|
change in serum FSH level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum FSH level
Časové okno: 8 weeks
|
change in serum FSH level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
serum estradiol (E2) level
Časové okno: 4 weeks
|
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum estradiol (E2) level
Časové okno: 8 weeks
|
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Časové okno: 4 weeks
|
% change in GIS after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Časové okno: 8 weeks
|
% change in GIS after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Rong Chen, Peking Union Medical College Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- XSKL20200422
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