ITMCTR2100004826已完成4 期
A multi-center, randomized, double-blind, double-simulated, positive drug parallel controlled clinical trial to evaluate the effectiveness and safety of Jiuwei Zhenxin Granules in the treatment of generalized anxiety disorder
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
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
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •1. Meet the DSM-IV generalized anxiety disorder (GAD) diagnostic criteria;
- •2. Hamilton Anxiety Scale (HAMA) total score >=14 points, of which the first item of anxiety item score >=2 points;
- •3. Hamilton Depression Rating Scale (HAMD) rating total score <17 points, and the third suicide item <3 points;
- •4. Aged from 18 to 70 years old;
- •5. Volunteer to participate and sign an informed consent form.
排除标准
- •1. Participate in other drug clinical trials within 30 days before the study;
- •2. Have used Jiuwei Zhenxin Granules at any time in the past;
- •3. Except for GAD, there are currently any DSM-IV axis I diagnoses;
- •Patients diagnosed with depression in the past 6 months;
- •Patients diagnosed with panic disorder, post-traumatic stress disorder or eating disorder in the past 1 year;
- •Have had obsessive-compulsive disorder, bipolar disorder, schizophrenia, schizoaffective mental disorder, somatoform disorder before;
- •4. There is a history of Axis II disorder or anti-social behavior, and the investigator judges that it will affect the patient's compliance with the research protocol;
- •5. According to the DSM-IV-TR criteria, patients have substance abuse or dependence and have not been completely relieved. According to the medical history, the investigator judges that the patient meets the DSM-IV-TR substance-related mental disorder;
- •6. Alanine aminotransferase (ALT) > 2 times the upper limit of normal; Aspartate aminotransferase (AST)>3 times the upper limit of normal; Total bilirubin (TBIL) > 1.5 times the upper limit of normal;
- •7. Other serious medical diseases, these diseases will affect the ability of patients to participate in this trial. The right to judge the decision belongs to the investigators;
- •8. It belongs to secondary anxiety of physical diseases such as thyroid dysfunction, hypertension, coronary heart disease;
- •9. Have epilepsy or have a history of epilepsy;
- •10. Patients with narrow-angle glaucoma and increased intraocular pressure.
- •11. Begin regular psychotherapy or paroxetine treatment within 90 days before baseline;
- •12. Use antipsychotic drugs, mood stabilizer treatment or MECT treatment within 30 days before baseline;
- •13. Have used monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days before baseline, or may need to use MAOI during the study or within 14 days of stopping the study drug;
- •14. Use antidepressants or anti-anxiety drugs within 14 days before baseline;
- •15. Use traditional Chinese herbal products for anxiety, insomnia or depression, or sedative and hypnotic drugs (except for permitted non-benzodiazepine hypnotics, and do not exceed the dose) within 7 days before baseline;
- •16. The use of 2 or more antidepressants and/or benzodiazepines in sufficient amounts, that is, treatment with a clinically appropriate dose for at least 4 weeks, but still ineffective;
- •17. Women who are pregnant or preparing to become pregnant or breast-feeding;
- •18. Patients who are known to be allergic to or have contraindications to Jiuwei Zhenxin Granules and Paroxetine;
- •19. Patients with a previous history of leukopenia or lack of white blood cells;
- •20. Other situations deemed unsuitable by the investigator.
研究者
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