ITMCTR2024000209已完成1 期
A randomized, double-blind, dose-parallel-controlled clinical study of the efficacy and safety of the four-inverse san plus and minus formula in the treatment of generalized anxiety disorder
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 69（—）
- 性别
- All
入选标准
- •1. Meet the DSM-V diagnostic criteria for generalized anxiety disorder prior to enrollment;
- •2. Conform to the traditional Chinese medicine syndrome differentiation of liver qi stagnation transforming into fire;
- •3. Age between 18 and 70 years old (inclusive of both limits), gender unrestricted;
- •4. HAMA score = 14 and = 29, with anxiety mood (item 1) scoring = 2 and depressive mood (item 6) scoring = 2;
- •5. The baseline HAMA score before enrollment shows a reduction rate of < 25% compared to the screening time.6. Voluntarily participating in this clinical trial, capable of cooperating with the researchers in conducting the trial, and signing the informed consent form.
排除标准
- •1. Concomitant psychiatric disorder with any of the following: delusional disorder, separation anxiety disorder, panic disorder, agoraphobia, anxiety disorder due to other somatic disorders, substance/medication-induced anxiety disorder, social anxiety disorder (social phobia), obsessive-compulsive disorder, post-traumatic stress disorder and adjustment disorder, depression, bipolar and psychotic disorder, anorexia nervosa;
- •2. Combination of any substance-related and addictive disorders, including alcohol, caffeine, marijuana, hallucinogens, inhalers, opioids, sedatives, hypnotic drugs, stimulants, tobacco, etc.;
- •3. Systemic psychotherapy has been received in the past or cannot be stopped during the trial;
- •4. Patients with severe or unstable heart, liver, kidney, endocrine, digestive, blood and other physical diseases;
- •5. Abnormal liver and kidney function: ALT or AST = 1.5 times the upper limit of normal, or SCr > upper limit of normal;
- •6. HAMD- 17 score=17 points;
- •7. Those who have suicidal tendencies as judged by the researcher;
- •8. Those who are unsupervised or unable to take medicine according to the doctor's instructions;
- •9. Known or suspected of having a history of allergy or serious adverse reactions to the test drug and its excipients, or allergic constitution;
- •10. Pregnant, lactating women or those who have recently planned to give birth;
- •11. Those who have participated in other drug clinical trials within 3 months before screening;
- •12. Other conditions that the investigator deems inappropriate to participate in this experiment;
研究者
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