ITMCTR2024000035尚未招募Unknown
A single-center, double-blind, randomized, placebo-controlled clinical study of Shuhe granule in the treatment of chronic insomnia with qi-blood disharmony and deficiency of both heart and kidney
Guangdong Provincial Hospitai of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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 65（—）
- 性别
- All
入选标准
- •(1) 18 to 65 years of age.
- •(2) meet the diagnostic criteria of chronic insomnia in western medicine.
- •(3) meet the diagnostic criteria of insomnia in traditional Chinese medicine.
- •(4) consistent with the syndrome of disharmony between qi and blood and deficiency of both heart and kidney.
- •(5) sign the informed consent form.
排除标准
- •(1) comply with any one of the excluded symptoms.
- •a. The lower eyelid is all red.
- •b. The hands are hot.
- •c. Stool dry knot, hard.
- •d. Thick, greasy or dry rough moss.
- •e. The pulse-to-interest ratio is greater than 5.
- •(2) people who are preparing for pregnancy or pregnancy or lactation or who need to accompany their children to sleep.
- •(3) according to medical history and consultation, doctors confirm secondary insomnia caused by other diseases. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.
- •(4) patients with severe depression were diagnosed according to the depression screening tool (PHQ-9) (total score = 15).
- •(5) patients with severe anxiety were diagnosed according to the generalized anxiety disorder scale (GAD-7) (total score = 15).
- •(6) patients with severe insomnia according to insomnia severity index (ISI) (total score = 22).
- •(7) those who have participated in clinical trials of other drugs in the past 30 days.
- •(8) complicated with other mental disorders.
- •(9) the hemoglobin level is less than 90g/L, the white blood cell count is less than 3.0 × 10 ^ 9 / L, or the platelet count is less than 100 × 10 ^ 9 / L.
- •(10) patients whose glomerular filtration rate is lower than that of 40ml/min.
- •(11) Aspartate aminotransferase or alanine aminotransferase was 1.5 times higher than the upper limit of the normal range.
研究者
相似试验
进行中（未招募）
不适用
A single-center, double-blind, randomized, placebo-controlled, cross-over study to assess the effect of vildagliptin on the incretin effect in patients with type 2 diabetes treated with metformiEUCTR2006-001219-31-DEovartis Pharma Services AG22
进行中（未招募）
不适用
A single-center, double-blind, randomized, placebo-controlled, cross-over study to assess the effect of vildagliptin on glucagon counterregulatory response during hypoglycemia in patients with type 2 diabetesType II DiabetesEUCTR2006-001218-34-SEovartis Pharma Services AG28
已完成
不适用
A single-center, double-blind, randomized, placebo-controlled Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects, including food effect, mass balance, and metabolite profilinginflammatory diseasesNL-OMON48421Idorsia Pharmaceuticals Ltd88
已完成
不适用
A single-center, double-blind, randomized, placebo-controlled, 13-week study to evaluate the efficacy and safety of one capsule of XTEND-LIFE compared to placebo, and an extended four-week trial to assess its benefit when combined with ezetimibe 10 mg per dayHypercholesterolemiaISRCTN36282240Connecticut Clinical Research LLC (USA)60
进行中（未招募）
1 期
Oxytocin TrialMedDRA version: 20.0Level: LLTClassification code 10003805Term: AutismSystem Organ Class: 100000004873Autism Spectrum DisorderEUCTR2013-003067-59-ITAZIENDA OSPEDALIERA G. BROTZ30