A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy and Safety of Xinfeng Capsule in the Treatment of Knee Osteoarthritis (KOA) :A Randomized, Double-blind, Double-dummy, Multi-center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167516
• Other study ID #: 1301042211
• Status: Completed
• Phase: N/A
• First received: June 15, 2014
• Last updated: August 18, 2015
• Start date: October 2014

Study information

• Verified date: August 2015
• Source: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: the department of science and technology of Anhui province
• Study type: Interventional

Clinical Trial Summary

Complementary and alternative medicine has been employed over thousands of years to relieve knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may explored its mechanism. However, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of KOA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants must meet the American College of Rheumatology (ACR) 1995 revised criteria for KOA.

• Participants must be aged between 40 and 75 years.

• Participants shall not take non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids during the 7 days prior to screening.

• Participants shall not take Chinese medicine for the treatment of KOA during the 7 days prior to screening.

• Joint function in the I-III, X-ray stage in the I-III.

• All participants shall agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

• Patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity.

• Patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures.

• Persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury .

• Patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases.

• Pregnant women or breastfeeding mothers or individuals with known psychiatric disorders.

• Patients who are hypersensitive to the trial medication.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• glucosamine sulfate
glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks
• Xinfeng capsule
Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Anhui University of Chinese Medicine	HeFei	Anhui
China	The Taihe County Hospital of Chinese Medicine	Taihe	Anhui
China	The Tianchang City Hospital of Chinese Medicine	Tianchang	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Osteoarthritis Index (WOMAC)		up to week 4	No
Secondary	Arthritis pain assessment using the Visual Analog scale (VAS)		baseline,week2,week4	No
Secondary	KOA severity using the Lequesne MG score		baseline,week2,week4	No
Secondary	Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium		baseline,week4	Yes
Secondary	Bilateral femoral bone mineral density.		baseline,week4	No
Secondary	Health assessment of the patient refer to the MOS item short from health survey (SF-36)		baseline,week4	No