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临床试验/NCT05454865
NCT05454865已完成不适用

The Effect of Jin Si Herbal Tea on Cancer-related Fatigue of Gynecological Cancer Patients

Buddhist Tzu Chi General Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年1月1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
21
试验地点
2
主要终点
Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)

研究概览

简要总结

Cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. Fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. Cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. Even after finished chemotherapy, most patients still feel fatigued.

Therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. This project plans to use the Jin Si herbal tea developed by our hospital to improve cancer-related fatigue.

详细描述

Cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. Fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. Cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. Even after finished chemotherapy, most patients still feel fatigued.

Therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. This project plans to use the Jin Si herbal tea developed by our hospital to improve cancer-related fatigue.

Jin Si Herbal Tea Brief mechanism of action: It contains eight kinds of traditional Chinese medicines, mainly including wormwood, fish needle grass, Ophiopogon japonicas, houttuynia cordata, platycodon, licorice, perilla leaves, and chrysanthemum, which promote lung health including dampness and clean lung heat, diuresis, generate body heat, anti-cold, clean blood, and reduce phlegm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double-blind setting

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who received chemotherapy
  • Patients who understand the experimental process

排除标准

  • Unconscious
  • Severe disease, not well-controlled patients judged by PI
  • Pregnancy, breastfeeding, menstruation during screening phase
  • Weakness, allergy to Herbal tea, frequently felt cold

结局指标

主要结局

Functional Assessment of Cancer Therapy-General (FACT-G7, Version 4)

时间窗: 2 months

scores 0-28, higher scores mean the worse outcome

Brief Fatigue Inventory-Taiwanese (BFI-T)

时间窗: 2 months

scores 0-90, higher scores mean the worse outcome

次要结局

  • Laboratory assessment (White Blood Cells count, Differential count)(2 months)

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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