Clinical trial NCT02167516: A Clinical Study of Xin'an Medicine in the Treatment of Knee Osteoarthritis
Official title: Efficacy and Safety of Xinfeng Capsule in the Treatment of Knee Osteoarthritis (KOA) :A Randomized, Double-blind, Double-dummy, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Xinfeng capsule
Knee osteoarthritis
Randomized controlled trials
Double-blind
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 268
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: up to week 4
Secondary outcomes:
measure: Arthritis pain assessment using the Visual Analog scale (VAS)
timeFrame: baseline,week2,week4
measure: KOA severity using the Lequesne MG score
timeFrame: baseline,week2,week4
measure: Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium
timeFrame: baseline,week4
measure: Bilateral femoral bone mineral density.
timeFrame: baseline,week4
measure: Health assessment of the patient refer to the MOS item short from health survey (SF-36)
timeFrame: baseline,week4
Other outcomes:
Locations:
city: HeFei
country: China
facility: the First Affiliated Hospital of Anhui University of Chinese Medicine
state: Anhui
city: Taihe
country: China
facility: The Taihe County Hospital of Chinese Medicine
state: Anhui
city: Tianchang
country: China
facility: The Tianchang City Hospital of Chinese Medicine
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui University of Chinese Medicine
name: Jian Liu
role: PRINCIPAL_INVESTIGATOR
References: