Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xiaonan Cui
- 入组人数
- 60
- 主要终点
- Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)
研究概览
简要总结
Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.
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
- All
- 接受健康志愿者
- 否
入选标准
- •General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
- •Pathology diagnosed;
- •Brain, heart, lung, liver, kidney are at good condition before surgery;
- •No mental disorder, no conscious obstacle, no limbs disability.
排除标准
- •Severely complication after surgery;
- •Contraindication of the acupuncture;
- •Patients with mental disease;
- •Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
研究组 & 干预措施
Control group
This group receives normal treatment after surgery,with no acupuncture.
干预措施: Laparoscopic Surgery (Procedure)
Experimental group
This group receives acupuncture therapy besides normal treatment after surgery. The acupuncture therapy starts after 24 hours of surgery, 1 time a day, 30 minutes every time, until the fifth day.
干预措施: Laparoscopic Surgery (Procedure)
Experimental group
This group receives acupuncture therapy besides normal treatment after surgery. The acupuncture therapy starts after 24 hours of surgery, 1 time a day, 30 minutes every time, until the fifth day.
干预措施: Acupuncture therapy (Device)
结局指标
主要结局
Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)
时间窗: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
次要结局
- Th17/Treg in blood(day 2, day 7 after surgery)
- Estradiol(Female) in blood(day 2, day 7 after surgery)
- 5-Hydroxytryptamine(5-HT) in blood(day 2,day 7 after surgery)
- Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability(day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery)
- Prostaglandin E2(PGE2) in blood(day 2,day 7 after surgery)
- Histamine(HIS) in blood(day 2,day 7 after surgery)
- Testosterone(Male) in blood(day 2,day 7 after surgery)
- Th1/Th2 in blood(day 2, day 7 after surgery)
研究者
Xiaonan Cui
Professor, Chief Physician
The First Affiliated Hospital of Dalian Medical University