NCT02167516

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

June 15, 2014

Last Update Submit

August 18, 2015

Conditions

Knee Osteoarthritis

Keywords

Xinfeng capsuleKnee osteoarthritisRandomized controlled trialsDouble-blind

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    up to week 4

Secondary Outcomes (5)

  • Arthritis pain assessment using the Visual Analog scale (VAS)

    baseline,week2,week4

  • KOA severity using the Lequesne MG score

    baseline,week2,week4

  • Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium

    baseline,week4

  • Bilateral femoral bone mineral density.

    baseline,week4

  • Health assessment of the patient refer to the MOS item short from health survey (SF-36)

    baseline,week4

Study Arms (2)

Xinfeng capsule

EXPERIMENTAL

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

Drug: Xinfeng capsule

glucosamine sulfate capsule

ACTIVE COMPARATOR

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

Drug: glucosamine sulfate

Interventions

glucosamine sulfateDRUG

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

glucosamine sulfate capsule
Xinfeng capsuleDRUG

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

Xinfeng capsule

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

the First Affiliated Hospital of Anhui University of Chinese Medicine

Hefei, Anhui, 230031, China

Location

The Taihe County Hospital of Chinese Medicine

Taihe Chengguanzhen, Anhui, 236600, China

Location

The Tianchang City Hospital of Chinese Medicine

Tianchang, Anhui, 239300, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosaminexinfeng

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydrates

Study Officials

  • Jian Liu

    The First Affiliated Hospital of Anhui University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor，Chief Physician

Study Record Dates

First Submitted

June 15, 2014

First Posted

June 19, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

CN(3)