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Efficacy of Kangliuwan for Recurrent Grade IV Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949192
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Qingtang Lin, Xuanwu Hospital, Beijing

Study Description
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Brief Summary:
A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.

Condition or disease
Glioma of Brain Recurrence

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Changes in tumor volume [ Time Frame: 3 months ]
    the volume of tumor decreased after taking Kangliuwan


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Recurrent grade IV glioma patients and conventional treatment is invalid.
Criteria

Inclusion Criteria:

  1. The patient signed "informed consent" voluntarily;
  2. The age of patient is between 18 and 80 years;
  3. KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;

Exclusion Criteria:

  1. The patient did not sign "informed consent" or signed unvoluntarily.
  2. Non-glioma patients
  3. Active infection
  4. Human immunodeficiency virus (HIV) positive
  5. Hepatitis C or hepatitis B infective
  6. Pregnancy or breast-feeding women
  7. Patients did not agree to use effective contraception during treatment and the following 3 months.
  8. Patients also participated in other clinical studies.
  9. The subjects researchers believe are not suitable for participation or completion of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949192


Contacts
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Contact: Qingtang Lin, MD. Ph.D 8610-83198362 linqingtang@xwhosp.orn
Contact: Ge Sun, B.A. 8610-83198362 sunge0923@126.com

Locations
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China, Beijing
Xuanwu Hospital Recruiting
Beijing, Beijing, China, 100054
Contact: Ge Sun, B.A.    8610-83168899    sunge@163.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Chair: Qingtang Lin, M.D., Ph.D. Xuanwu Hospital, Beijing
Principal Investigator: Xiaolan Lin, M.D. Xuanwu Hospital, Beijing
Principal Investigator: Ling Chen, M.D. The General Hospital of People's Liberation Army (301 hospital)
More Information
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Responsible Party: Qingtang Lin, assistant director physician, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03949192    
Other Study ID Numbers: LYS [2019] 027
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Recurrence
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes