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Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02484508
Recruitment Status : Unknown
Verified June 2015 by Guizhou Bailing Group Pharmaceutical Co Ltd.
Recruitment status was:  Recruiting
First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborators:
Wangjing Hospital, China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
People's Hospital of Guizhou Province
Information provided by (Responsible Party):
Guizhou Bailing Group Pharmaceutical Co Ltd

Brief Summary:

Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.

To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Guli capsule Drug: Kangguzengsheng capsule Phase 4

Detailed Description:

Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.

Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.

To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Guli capsule
Guli capsule, the tested drug of this study
Drug: Guli capsule
Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day
Other Name: GL capsule

Active Comparator: Kangguzengsheng capsule
Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study
Drug: Kangguzengsheng capsule
Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day
Other Name: KGZS capsule




Primary Outcome Measures :
  1. Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 4 weeks ]
  2. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages between 40 and 70 years, both gender
  • Kellgren and Lawrence grades of I to III;
  • The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
  • Meet the following clinical and radiological criteria for diagnosis:
  • Clinical criteria:

    1. most of the time have knee pain nearly a month
    2. bone fricative
    3. morning stiffness is less than or equal to 30 min
    4. age is more than or equal to 38 years
    5. bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
  • Radiological criteria:

    1. most of the time have knee pain nearly a month
    2. the X-ray showed osteophyte formation
    3. joint fluid examination confirmed with osteoarthritis
    4. age is more than or equal to 40 years
    5. morning stiffness is less than or equal to 30 min
    6. bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).

Exclusion Criteria:

  • Patient with a history of allergy to similar constituents or chemical components of the drug;
  • Patients with limited liver and kidney function;
  • Patients with hematopoietic system disease;
  • Patients with diabetes, Cushing's syndrome and other endocrine disorders;
  • Patients with severe heart and brain disease;
  • Patients with low immunity;
  • Patients directly involved with the staff in the study;
  • Women during pregnancy or lactation;
  • Participating in other clinical studies or Participated in 3 months;
  • The investigators judged who be unfit for the study.

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): NCT02484508


Contacts
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Contact: Weiheng Chen, MD Dr. +861084739047 weihchenwj@126.com
Contact: Jiuyi Chen, MD Dr. +868515609789 jiuyichen@sina.com

Locations
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China, Beijing
Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine Recruiting
Beijing, Beijing, China, 100102
Contact: Weiheng Chen, MD Dr.    +861084739047    weihchenwj@126.com   
Contact: Jiuyi Chen, MD Dr.    +868515609789    jiuychen77@sohu.com   
Principal Investigator: Weiheng Chen, MD Dr.         
Sub-Investigator: Jiuyi Chen, MD Dr.         
Sub-Investigator: Min Huang, MD Dr.         
Sponsors and Collaborators
Guizhou Bailing Group Pharmaceutical Co Ltd
Wangjing Hospital, China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
People's Hospital of Guizhou Province
Investigators
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Principal Investigator: Weiheng Chen, MD Dr. ICMJE

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Responsible Party: Guizhou Bailing Group Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02484508     History of Changes
Other Study ID Numbers: GL-15-01
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Guizhou Bailing Group Pharmaceutical Co Ltd:
Guli capsule
knee osteoarthritis
Changing of WOMAC and VAS score

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases