Effets des granules Xiangshao sur l'anxiété chez les femmes ménopausées.
Effets des granules de Xiangshao sur l'anxiété chez les femmes ménopausées : une étude multicentrique, randomisée, en double aveugle et contrôlée par placebo.
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Anhui
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Hefei, Anhui, Chine
- Anhui Province Maternity & Child Health Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 010
- Peking Union Medical College Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chine
- Chongqing Health Center for Women and Children
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Gansu
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Lanzhou, Gansu, Chine
- Gansu Provincial Maternity and Child-care Hospital
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Hebei
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Cangzhou, Hebei, Chine
- Cangzhou People's Hospital
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Shijiangzhuang, Hebei, Chine
- Second Hospital of Hebei Medical University
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Henan
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Kaifeng, Henan, Chine
- The First Affiliated Hospital of Henan University
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Zhengzhou, Henan, Chine
- Zhengzhou Central Hospital Affiliated to Zhengzhou University
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Hunan
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Changsha, Hunan, Chine
- Second Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Chine
- Jiangsu Province Hospital of Chinese Medicine
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Taizhou, Jiangsu, Chine
- Taizhou People's Hospital
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Zhangjiagang, Jiangsu, Chine, 0512
- Zhangjiagang First People's Hospital
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Jiangxi
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Nanchang, Jiangxi, Chine
- Jiangxi Maternal and Child Health Hospital
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Liaoning
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Dalian, Liaoning, Chine
- Affiliated Zhongshan Hospital of Dalian University
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Shandong
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Liaocheng, Shandong, Chine
- Liaocheng People's Hospital
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Sichuan
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Chengdu, Sichuan, Chine
- Chengdu Women's and Children's Central Hospital
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Chengdu, Sichuan, Chine
- 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, Chine
- Tianjin Hospital of ITCWM Nankai Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur placebo: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-rating Anxiety Scale (SAS) scores change (%)
Délai: 8 weeks
|
% change in SAS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SAS scores change (%)
Délai: 4 weeks
|
% change in SAS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Délai: 4 weeks
|
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Délai: 8 weeks
|
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
Self-rating Depression Scale (SDS) scores change (%)
Délai: 4 weeks
|
% change in SDS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
SDS scores change (%)
Délai: 8 weeks
|
% change in SDS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
serum Follicle Stimulating Hormone (FSH) level
Délai: 4 weeks
|
change in serum FSH level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum FSH level
Délai: 8 weeks
|
change in serum FSH level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
serum estradiol (E2) level
Délai: 4 weeks
|
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum estradiol (E2) level
Délai: 8 weeks
|
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Délai: 4 weeks
|
% change in GIS after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Délai: 8 weeks
|
% change in GIS after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rong Chen, Peking Union Medical College Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- XSKL20200422
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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