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

Phase 4

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Guli capsule; Drug: Kangguzengsheng capsule

• Registration Number: NCT02484508
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-03
• Status Verified: 2015-06
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-24
• Last Update Submitted: 2015-06-24
• Study First Posted: 2015-06-29
• Last Update Posted: 2015-06-29
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guli capsule	Guli capsule	Guli capsule, the tested drug of this study
Kangguzengsheng capsule	Kangguzengsheng capsule	Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study

Primary Outcome Measures

Name	Time	Method
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine; 🇨🇳 Beijing, Beijing, China