Virkninger af Xiangshao-granulat på angst hos kvinder i overgangsalderen.
Virkninger af Xiangshao-granulat på angst hos kvinder i overgangsalderen: En multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Anhui
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Hefei, Anhui, Kina
- Anhui Province Maternity & Child Health Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 010
- Peking Union Medical College Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina
- Chongqing Health Center for Women and Children
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Gansu
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Lanzhou, Gansu, Kina
- Gansu Provincial Maternity and Child-care Hospital
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Hebei
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Cangzhou, Hebei, Kina
- Cangzhou People's Hospital
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Shijiangzhuang, Hebei, Kina
- Second Hospital of Hebei Medical University
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Henan
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Kaifeng, Henan, Kina
- The First Affiliated Hospital of Henan University
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Zhengzhou, Henan, Kina
- Zhengzhou Central Hospital Affiliated to Zhengzhou University
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Hunan
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Changsha, Hunan, Kina
- Second Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Kina
- Jiangsu Province Hospital of Chinese Medicine
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Taizhou, Jiangsu, Kina
- Taizhou People's Hospital
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Zhangjiagang, Jiangsu, Kina, 0512
- Zhangjiagang First People's Hospital
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Jiangxi
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Nanchang, Jiangxi, Kina
- Jiangxi Maternal and Child Health Hospital
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Liaoning
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Dalian, Liaoning, Kina
- Affiliated Zhongshan Hospital of Dalian University
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Shandong
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Liaocheng, Shandong, Kina
- Liaocheng People's Hospital
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Sichuan
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Chengdu, Sichuan, Kina
- Chengdu Women's and Children's Central Hospital
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Chengdu, Sichuan, Kina
- School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina
- Tianjin Hospital of ITCWM Nankai Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Placebo komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-rating Anxiety Scale (SAS) scores change (%)
Tidsramme: 8 weeks
|
% change in SAS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SAS scores change (%)
Tidsramme: 4 weeks
|
% change in SAS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Tidsramme: 4 weeks
|
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Tidsramme: 8 weeks
|
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
Self-rating Depression Scale (SDS) scores change (%)
Tidsramme: 4 weeks
|
% change in SDS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
SDS scores change (%)
Tidsramme: 8 weeks
|
% change in SDS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
serum Follicle Stimulating Hormone (FSH) level
Tidsramme: 4 weeks
|
change in serum FSH level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum FSH level
Tidsramme: 8 weeks
|
change in serum FSH level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
serum estradiol (E2) level
Tidsramme: 4 weeks
|
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum estradiol (E2) level
Tidsramme: 8 weeks
|
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Tidsramme: 4 weeks
|
% change in GIS after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Tidsramme: 8 weeks
|
% change in GIS after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Rong Chen, Peking Union Medical College Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XSKL20200422
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