Pain Clinical Trial
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 |
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 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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xiaonan Cui |
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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