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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02871999
Other study ID # LCKY2016-39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date January 1, 2019

Study information

Verified date January 2019
Source The First Affiliated Hospital of Dalian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 1, 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;

2. Pathology diagnosed;

3. Brain, heart, lung, liver, kidney are at good condition before surgery;

4. No mental disorder, no conscious obstacle, no limbs disability.

Exclusion Criteria:

1. Severely complication after surgery;

2. Contraindication of the acupuncture;

3. Patients with mental disease;

4. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acupuncture therapy

Procedure:
Laparoscopic Surgery


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Xiaonan Cui

Outcome

Type Measure Description Time frame Safety issue
Primary Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS) day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
Secondary 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
Secondary Prostaglandin E2(PGE2) in blood day 2,day 7 after surgery
Secondary Estradiol(Female) in blood day 2, day 7 after surgery
Secondary Th1/Th2 in blood day 2, day 7 after surgery
Secondary 5-Hydroxytryptamine(5-HT) in blood day 2,day 7 after surgery
Secondary Histamine(HIS) in blood day 2,day 7 after surgery
Secondary Th17/Treg in blood day 2, day 7 after surgery
Secondary Testosterone(Male) in blood day 2,day 7 after surgery
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