Clinical trial NCT02484508: Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Official title: A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Guli capsule
knee osteoarthritis
Changing of WOMAC and VAS score
Lead sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
name: People's Hospital of Anshun City of Guizhou Province
First posted: 2015-06-29
Enrollment: 220
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 4 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine
state: Beijing
Study officials:
affiliation: ICMJE
name: Weiheng Chen, MD Dr.
role: PRINCIPAL_INVESTIGATOR
References: