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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
glucosamine sulfate
Xinfeng capsule
Sponsored by
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Xinfeng capsule, Knee osteoarthritis, Randomized controlled trials, Double-blind

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the First Affiliated Hospital of Anhui University of Chinese Medicine
  • The Taihe County Hospital of Chinese Medicine
  • The Tianchang City Hospital of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xinfeng capsule

glucosamine sulfate capsule

Arm Description

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

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

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Osteoarthritis Index (WOMAC)

Secondary Outcome Measures

Arthritis pain assessment using the Visual Analog scale (VAS)
KOA severity using the Lequesne MG score
Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium
Bilateral femoral bone mineral density.
Health assessment of the patient refer to the MOS item short from health survey (SF-36)

Full Information

First Posted
June 15, 2014
Last Updated
August 18, 2015
Sponsor
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02167516
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Xinfeng capsule, Knee osteoarthritis, Randomized controlled trials, Double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xinfeng capsule
Arm Type
Experimental
Arm Description
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
Arm Title
glucosamine sulfate capsule
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
glucosamine sulfate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Xinfeng capsule
Intervention Description
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
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time Frame
up to week 4
Secondary Outcome Measure Information:
Title
Arthritis pain assessment using the Visual Analog scale (VAS)
Time Frame
baseline,week2,week4
Title
KOA severity using the Lequesne MG score
Time Frame
baseline,week2,week4
Title
Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium
Time Frame
baseline,week4
Title
Bilateral femoral bone mineral density.
Time Frame
baseline,week4
Title
Health assessment of the patient refer to the MOS item short from health survey (SF-36)
Time Frame
baseline,week4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Liu
Organizational Affiliation
The First Affiliated Hospital of Anhui University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Anhui University of Chinese Medicine
City
HeFei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
The Taihe County Hospital of Chinese Medicine
City
Taihe
State/Province
Anhui
ZIP/Postal Code
236600
Country
China
Facility Name
The Tianchang City Hospital of Chinese Medicine
City
Tianchang
State/Province
Anhui
ZIP/Postal Code
239300
Country
China

12. IPD Sharing Statement

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

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