Effetti dei granuli Xiangshao sull'ansia nelle donne in menopausa.
Effetti dei granuli Xiangshao sull'ansia nelle donne in menopausa: uno studio multicentrico, randomizzato, in doppio cieco, controllato con 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Anhui
-
Hefei, Anhui, Cina
- Anhui Province Maternity & Child Health Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Cina, 010
- Peking Union Medical College Hospital
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Cina
- Chongqing Health Center for Women and Children
-
-
Gansu
-
Lanzhou, Gansu, Cina
- Gansu Provincial Maternity and Child-care Hospital
-
-
Hebei
-
Cangzhou, Hebei, Cina
- Cangzhou People's Hospital
-
Shijiangzhuang, Hebei, Cina
- Second Hospital of Hebei Medical University
-
-
Henan
-
Kaifeng, Henan, Cina
- The First Affiliated Hospital of Henan University
-
Zhengzhou, Henan, Cina
- Zhengzhou Central Hospital Affiliated to Zhengzhou University
-
-
Hunan
-
Changsha, Hunan, Cina
- Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, Cina
- Jiangsu Province Hospital of Chinese Medicine
-
Taizhou, Jiangsu, Cina
- Taizhou People's Hospital
-
Zhangjiagang, Jiangsu, Cina, 0512
- Zhangjiagang First People's Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Cina
- Jiangxi Maternal and Child Health Hospital
-
-
Liaoning
-
Dalian, Liaoning, Cina
- Affiliated Zhongshan Hospital of Dalian University
-
-
Shandong
-
Liaocheng, Shandong, Cina
- Liaocheng People's Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Cina
- Chengdu Women's and Children's Central Hospital
-
Chengdu, Sichuan, Cina
- School of Clinical medicine & The First Affiliated Hospital of Chengdu Medical College
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Cina
- Tianjin Hospital of ITCWM Nankai Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Comparatore 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Self-rating Anxiety Scale (SAS) scores change (%)
Lasso di tempo: 8 weeks
|
% change in SAS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
SAS scores change (%)
Lasso di tempo: 4 weeks
|
% change in SAS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Lasso di tempo: 4 weeks
|
% change in Kupperman scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
Kupperman scores change (%)
Lasso di tempo: 8 weeks
|
% change in Kupperman scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
Self-rating Depression Scale (SDS) scores change (%)
Lasso di tempo: 4 weeks
|
% change in SDS scores after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
SDS scores change (%)
Lasso di tempo: 8 weeks
|
% change in SDS scores after 8 weeks of treatment compared with baseline scores |
8 weeks
|
|
serum Follicle Stimulating Hormone (FSH) level
Lasso di tempo: 4 weeks
|
change in serum FSH level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum FSH level
Lasso di tempo: 8 weeks
|
change in serum FSH level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
serum estradiol (E2) level
Lasso di tempo: 4 weeks
|
change in serum estradiol(E2) level after 4 weeks of treatment compared with baseline |
4 weeks
|
|
serum estradiol (E2) level
Lasso di tempo: 8 weeks
|
change in serum estradiol(E2) level after 8 weeks of treatment compared with baseline |
8 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Lasso di tempo: 4 weeks
|
% change in GIS after 4 weeks of treatment compared with baseline scores |
4 weeks
|
|
gastrointestinal symptom score (GIS) change (%)
Lasso di tempo: 8 weeks
|
% change in GIS after 8 weeks of treatment compared with baseline scores |
8 weeks
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Rong Chen, Peking Union Medical College Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- XSKL20200422
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .