Based on the Theory of Gut-brain Axis, the Intervention Effect and Related Mechanism of Ganoderma Lucidum Spore Powder on Depressive Symptoms in Patients With Thyroid Cancer Were Investigated
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Depression symptoms relieved
研究概览
简要总结
To clarify the clinical effect of Ganoderma lucidum spore powder intervention on postoperative depressive symptoms of papillary thyroid carcinoma ; to elucidate the antidepressant mechanism of Ganoderma lucidum spore powder.
详细描述
After being informed of the study and potential risks, all patients who gave written informed consent were enrolled. A total of 300 eligible patients were randomly assigned in a double-blind manner and divided into experimental group and control group at a ratio of 2 : 1. The subjects were given oral test drugs ( Ganoderma lucidum spore powder or placebo ) 4g per day for 90 days from the first day after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with depressive symptoms after surgery for papillary thyroid carcinoma in the outpatient department of Zhejiang Cancer Hospital
- •Han nationality
- •No previous depression and other mental diseases
- •18-80 years old
- •BMI 19 ~ 24
排除标准
- •suffering from other diseases of the intestinal system
- •Gastrointestinal surgery was performed before intervention
- •Including patients with other malignant tumors, who need chemotherapy, radiotherapy, biological therapy or traditional Chinese medicine treatment received antibiotics or microecological modulators within 3 months before the intervention
- •Acute intestinal obstruction
- •Patients with severe depressive symptoms who must receive antidepressant treatment organic diseases such as heart and brain diseases, brain trauma history of mental illness, use of psychoactive drugs such as drugs
- •Severe liver and kidney dysfunction
- •Pregnancy, lactation
研究组 & 干预措施
Ganoderma lucidum spore powder
Oral administration of Ganoderma lucidum spore powder 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days
干预措施: Ganoderma lucidum spore powder (Dietary Supplement)
placebo
Oral ' placebo ' 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days.
干预措施: placebo (Other)
结局指标
主要结局
Depression symptoms relieved
时间窗: Day0,Month3
hamilton depression rating scale relieved from 8-20 to ≤8
次要结局
- Changes of intestinal microbial diversity in patients(Day0,Month3)
研究者
Ling Zhiqiang
Principal Investigator
Zhejiang Cancer Hospital