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临床试验/NCT06429514
NCT06429514已完成不适用

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

Ling Zhiqiang1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2023年3月28日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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

发起方
Ling Zhiqiang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ling Zhiqiang

Principal Investigator

Zhejiang Cancer Hospital

研究点 (1)

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