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Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels (OA knee Plai)

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ClinicalTrials.gov Identifier: NCT01836393
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
and Bangkok drugs Co.
Information provided by (Responsible Party):
Weerachai Kosuwon, Khon Kaen University

Brief Summary:
To determine whether plai cream is effective in treating mild to moderate degrees of osteoarthritis of the knee in the elderly patient compared with placebo cream.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Plavina cream Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: placebo and plai
The essential plai cream has anti-inflammatory and antimicrobial effects (Wasuwat1989, Giwanon 2000, Pithayanukul 2007, and Tripathi 2008). Active chemicals of plai cream are composed of sabinene, alpha and gamma tepinenes, terpinen 4-ol and (E)-1-(3,4-dimethoxyphenyl butadiene (DMPBD). The DMPBD has a property of anti-inflammatory activity(Ozaki 1991, Jeenapongsa 2003). Plavina® 40 mg in 100 gm (contains DMPBD of …%). This product was supplied in lacquered aluminum collapsible tube containing 100 gram cream packing.
Drug: Plavina cream
The essential plai cream has anti-inflammatory and antimicrobial effects (Wasuwat1989, Giwanon 2000, Pithayanukul 2007, and Tripathi 2008). Active chemicals of plai cream are composed of sabinene, alpha and gamma tepinenes, terpinen 4-ol and (E)-1-(3,4-dimethoxyphenyl butadiene (DMPBD). The DMPBD has a property of anti-inflammatory activity(Ozaki 1991, Jeenapongsa 2003). Plavina® 40 mg in 100 gm (contains DMPBD of …%). This product was supplied in lacquered aluminum collapsible tube containing 100 gram cream packing.




Primary Outcome Measures :
  1. This endpoint will be VAS, measured at visit 2-13 (week 1-12) Primary endpoint VAS: The primary endpoint is the change from baseline in VAS. This endpoint will be measured at visit 2-13 (week 1-12) VAS [ Time Frame: 3 months ]
    VAS 0-100 mm. using questionnaire


Secondary Outcome Measures :
  1. WOMAC and [ Time Frame: 3 months ]
    The WOMAC score is a tri-dimensional, disease-specific, self-administered health status measure, probing clinically important, subject-relevant symptoms in the area of pain. The subject will answer WOMAC question on pain subscale, using the Linkert scale 0-100 at screening 1st visit to determine eligibility for inclusion in the study. The subject will complete the entire WOMAC questionnaire during visit 2-13 (week 1-12)



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects eligible for enrollment in the study met all of the following criteria:

  1. Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  2. Ambulatory nom pregnant females and males 40-<80 years of age.
  3. Subjects who withdraw pain medication or nutritional supplements for symptom relief for knee OA for a total of at least 15 days before screening.
  4. Pain at or below 80 mm on a 100 mm VAS in the index knee.
  5. A documented diagnosis of OA of the knee, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening. If OA is presented in both knees the investigator will identify which knee will be X-rayed for study entry, with preference for the knee with more severe pain (<80mm VAS).
  6. Has documented radiographic evidence of OA of the knee from the screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading (11)
  7. Subjects with baseline minimum joint space width in the medial and lateral compartments of the index knee of > 1.5 mm and > 2.5 mm at Baseline respectively, measured from radiographs using the MTP view.

Exclusion Criteria

Subjects with any of the following criteria must not be enrolled in the study:

  1. Subjects with history of hypersensitivity to Plai.
  2. Subjects with skin lesion at the index knee.
  3. A history of lower extremity surgery within 6 months prior to screening.
  4. Significant prior injury to the index knee within 12 months prior to screening
  5. Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
  6. Treatment with other drugs potentially affecting bone or cartilage metabolism as described below:

    • chronic systematic corticosteroids
    • hyaluronan injection into the index knee with in the previous 6 months.
    • Diacerin or Glucosamine treatment within the last 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836393


Locations
Thailand
Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Thailand
Khon Kaen, Thailand, 40001
Faculty of Medicine KhonKaen University
Khonkaen, Thailand, 40001
Sponsors and Collaborators
Khon Kaen University
and Bangkok drugs Co.
Investigators
Principal Investigator: Weerachai Kosuwon, Doctor Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Thailand

Publications:
Responsible Party: Weerachai Kosuwon, Department of Orthopedics, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01836393     History of Changes
Other Study ID Numbers: KKU Ortho Plai
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Keywords provided by Weerachai Kosuwon, Khon Kaen University:
Plai
Efficacy
OA knee
The efficacy study of Plai cream for OA knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents