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Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Chemo Patients With Digestive Tract .

NCT03455205 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2018-03-06

No results posted yet for this study

Summary

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

Conditions

  • Digestive Tract

Interventions

DRUG

shenqifuzheng

500ml shenqifuzheng daily（at day 1-7and day22-28）through intravenous infusion.

DRUG

0.9%sodium chloride

500ml sodium chloride（0.9%）daily（at day 1-7 and day22-28）through intravenous infusion.

Sponsors & Collaborators

  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    collaborator OTHER

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Principal Investigators

  • lin lizhu, Dr. · First affiliated hospital of guangzhou university of traditional Chinese medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-24
Primary Completion
2019-12-30
Completion
2019-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455205 on ClinicalTrials.gov