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

Guizhou Bailing Group Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Kangguzengsheng capsule; Drug: Guli capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02484508

GL-15-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Guli capsule

Experimental group

Description:

Guli capsule, the tested drug of this study

Treatment:

Drug: Guli capsule

Kangguzengsheng capsule

Active Comparator group

Description:

Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study

Treatment:

Drug: Kangguzengsheng capsule