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

A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Guli capsule; Drug: Kangguzengsheng capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100102
      • Recruiting
      • Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine
      • Contact: Weiheng Chen, MD Dr.; Phone Number: +861084739047; Email: weihchenwj@126.com
      • Contact: Jiuyi Chen, MD Dr.; Phone Number: +868515609789; Email: jiuychen77@sohu.com
      • Principal Investigator: Weiheng Chen, MD Dr.
      • Sub-Investigator: Jiuyi Chen, MD Dr.
      • Sub-Investigator: Min Huang, MD Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: KGZS capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain Scores on the Visual Analog Scale	4 weeks
Number of Participants with Adverse Events as a Measure of Safety	4 weeks

Collaborators and Investigators

• Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
• 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
• Investigators: Principal Investigator: Weiheng Chen, MD Dr., ICMJE

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Estimate): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: knee osteoarthritis; Guli capsule; Changing of WOMAC and VAS score
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: GL-15-01