Digestive Tract Clinical Trial
Official title:
The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials
The efficacy and safety of cancer patients in patients with gastrointestinal cancer (chemotherapy) in patients with gastrointestinal tumor (chemotherapy) were prospectively, randomized blind, multicenter clinical trials. They were randomly divided into 2 groups, test group Shenqifuzheng injection of 500 ml, the control group 0.9% sodium chloride injection, 500 ml, intravenous drip, 1 times a day, 7 days post, rest is 14 days, 21 days each for a period of treatment, observation of two procedures. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment. The main curative effect of the clinic was to evaluate the pretreatment of cancer due to the fatigue score of the patients before and after treatment -- the Piper fatigue revision scale was used to evaluate the Chinese version. Assess effectiveness and safety based on clinical assessment
Factors for the purpose of this study by observing theShenqifuzheng injection before and
after treatment in patients with carcinoma due to fatigue scale scores, the classification of
syndromes, the quality of life score changes and related laboratory index, evaluation factors
ginseng and astragalus injection on the digestive tract tumor (chemotherapy) in patients with
cancer-related fatigue and quality of life improved efficacy and safety. The experimental
group was randomly divided into 2 groups, experimental group Shenqifuzheng injection of 500
ml. The control group was 0.9% sodium chloride injection, 500ml, intravenous drip, 1 time
daily, 7 days for continuous use, 14 days of rest, and 1 treatment for each 21 days, and 2
courses were observed. At the same time, according to the NCCN guide and the health ministry
issued the diagnosis and treatment guidelines for cancer treatment.
Main efficacy evaluation indexes before and after treatment for cancer-related fatigue rating
- adopting the Piper fatigue scale revised Chinese version, compare the experimental group
and the control group before and after treatment cancer-related fatigue rating difference
have differences. Secondary efficacy evaluation index to compare the ECOG score difference
before and after the treatment, the quality of life score difference before and after the
treatment, TCM syndrome curative effect, single symptom curative effect of immune function,
tumors had curative effect (if any) and chemotherapy completion. Safety assessment includes
the observation of vital signs, blood routine, urinary routine, routine stool, liver
function, renal function, electrocardiogram examination, and adverse reactions during the
treatment.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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