ITMCTR2000003198招募中1 期
Effectiveness of Chinese Herbal Medicine and Traditional-Chinese-Medicine-based Psychotherapy for Perimenopausal Depression in Chinese Women: a Randomized, Controlled Trial.
Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- Female
入选标准
- •1. Patients who meet the following diagnostic criteria:
- •Premature ovarian insufficiency (POI)
- •(1) Aged < 40 years;
- •(2) Menstruation is rare or stopped for at least 4 months;
- •(3) At least 2 times serum basal FSH > 25U / L (interval > 4 weeks);
- •(4) In subclinical stage, the level of POI: FSH is 15-25 U / L, which is a high-risk group.
- •Diagnostic criteria of Western medicine for menopausal syndrome (PMS)
- •(1) 40 <= age <= 60;
- •(2) The menstrual cycle is different in length, 2 or more times in 10 menstrual cycles have the change of adjacent menstrual cycle >= 7 days, or the menstrual cycle >= 60 days, and the blood FSH >= 25U / L.
- •TCM syndrome standard:
- •(1) Main symptoms: delayed menstrual cycle, sore waist and knees, abnormal emotions (emotional depression, irritability);
- •(2) Secondary symptoms: sweating, chest distress and sigh, poor sleep;
- •(3) The tongue is dull with thin yellow coating and thin vein.
- •2. The score of SAS and SDS was >= 62 (standard score).
- •3. According to DSM-V, patients with depression and / or anxiety disorders were diagnosed, and the symptoms lasted for at least 30 days before screening; the depression / anxiety symptoms appeared in the menopausal transition period; and the depression / anxiety symptoms could not be explained by other physical and mental diseases.
- •4. Patients who have not used hormone therapy, selective estrogen receptor modulator or aromatase inhibitor, soybean extract or herbal medicine in the past three months;
- •5.18 < BMI< 24;
- •6. Patients who are willing and able to sign informed consent.
排除标准
- •1. Patients with the following history of gynecological pelvic surgery: ovarian cyst exfoliation, ovarian perforation, ovarian wedge resection, appendectomy, salpingectomy, tubal ligation, pelvic abscess surgery, uterine artery embolization, etc.; or those who have used reproductive toxic drugs, such as Lei gongteng, Kunming Begonia, torch flower root tablet, chemotherapy drugs, etc.
- •2. Patients with a family history of premature ovarian failure or premature ovarian failure or other endocrine disorders such as hyperprolactinemia, polycystic ovarian syndrome and thyroid disease;
- •3. Those who have a history of habitual use of antibiotics or have used antibiotics, probiotics, prebiotics, microecological live bacteria preparations, cathartic or other drugs that affect gastrointestinal function in the past 1 month;
- •4. Patients with breast, digestive tract, reproductive tract cancer and gastrointestinal dysfunction (such as acute and chronic enteritis, constipation, diarrhea, Crohn's syndrome);
- •5. Patients who have recently had fertility requirements or pregnant or lactating women;
- •6. Patients with severe liver, kidney, heart and brain diseases; patients with uncontrolled or untreated hypertension (systolic blood pressure > 160mmhg and / or diastolic blood pressure > 100mmhg), uncontrolled or untreated diabetes mellitus; or patients with PTH abnormalities that may cause similar symptoms to POI;
- •7. Those with suicidal tendencies;
- •8. Patients with some allergic diseases such as asthma.
研究者
相似试验
招募中
1 期
Effectiveness of Chinese herbal medicine as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer: a real-world pragmatic clinical trialBreast cancerITMCTR2023000054ational Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taiwan
已完成
不适用
Traditional Chinese medicine (TCM) for cancerCancerISRCTN70448213niversity of British Columbia (Canada)80
已完成
不适用
The effectiveness of traditional Chinese medicine integrates with slump stretching on chronic non-specific low back pain symptoms among tea plantation farmer in Chiang RaiChronic non-specific low back pain symptoms among tea plantation farmer in Chiang Raiacupuncture, cupping therapy, low back pian, stretching, tea plantation farmersTCTR20221222006Mae Fah Luang University42
招募中
不适用
The Efficacy of Traditional Chinese Medicine Syndrome Differentiation Treatment for COVID 19 Patients: a Non-Randomized Controlled StudyCovid 19ITMCTR2200005848The Affiliated Hospital to Changchun University of Chinese Medicine
尚未招募
不适用
Clinical efficacy of traditional Chinese medicine in the treatment of acute pancreatitis: a prospective cohort studyacute pancreatitisITMCTR1900002308First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine