Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Osteoarthritis is the most common of the arthritides, affecting at least 20 million Americans, a number that is expected to double over the next two decades. currently available medical therapies primarily address the treatment of joint pain in patients with osteoarthritis.Analgesics as well as traditional and cyclooxygenase-2-selective nonsteriodal anti-inflammatory drugs (NSAIDs) have suboptimal effectiveness,and there is some question about their safety, especially in the light of recent reports of increased cardiovascular risk.
Plai (Zingiber cassumunar Roxb.) belongs to family of Ginger. Plai essential cream also has an activity on scavenging H2O2 generated by ultrasound exposure. The dilutions of 1:2,000 and 1:1,000 (v:v) of plai cream presented H2O2 scavenging activity by reducing emissions of DCFH-fluorescence within U937 cells, compared with the cell control. Plai essential cream inhibited nitric oxide (NO) production in the macrophage cell line (J774), compared with untreated cells. However, high concentrations of plai cream (1:1 and 1:10), were toxic to U937 and J744 cell lines. Moreover, plai cream at dilutions of 1:1,000 and 1:2,000, significantly inhibited COX II activity in treated cells compared to the untreated cells. Three major compounds of plai essential cream were sabinene, terpinen-4-ol and (E)-1-(3,4-dimethyoxyphenyl) butadiene respectively.There have been many studies on the efficacy of Plai as an analgesic and anti-inflammatory when applied directly to the affected area. The majority of these studies have been carried out in Thailand as this is where the plant originates from and it is used extensively in Thai massage and herbal medicine. The anti-inflammatory activity of a compound found in Plai extracts was assessed and compared with aspirin, and two other lesser known anti-inflammatory drugs. The results obtained showed that the anti-inflammatory effect of the compound (compound D) mainly occurred in the acute phase of inflammation.Moreover, the anti-inflammatory affect of plai oil was twice as potent as Diclofenac. The Plai cream was shown to reduce swelling and pain significantly in athletic ankle sprain in the first 2-3 days of the treatment.
These findings suggest that topical plai cream is a safe and potentially useful drug for the treatment of painful OA of the joints, however, there has been no efficacious study on the plai cream namely Plaivana® for relieving symptoms in patient with OA knee joint before, therefore, this study is proposed.
Subject selection and withdrawal criteria Number of subjects A sufficient number of subjects with OA of the knee will be screened in order to randomize at least 100 subjects (100 pairs) The study should provide 92 subjects (92 pairs) evaluable subjects, assuming that 10% of subjects will withdraw before having one the last assessment in the primary outcome variable.
Objectives Primary To evaluate the pain control using VAS of Plai cream 14 gm/100 (Plaivana®) compared with placebo cream in patient with OA knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects eligible for enrollment in the study met all of the following criteria:
- •Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Ambulatory nom pregnant females and males 40-<80 years of age.
- •Subjects who withdraw pain medication or nutritional supplements for symptom relief for knee OA for a total of at least 15 days before screening.
- •Pain at or below 80 mm on a 100 mm VAS in the index knee.
- •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).
- •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)
- •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:
- •Subjects with history of hypersensitivity to Plai.
- •Subjects with skin lesion at the index knee.
- •A history of lower extremity surgery within 6 months prior to screening.
- •Significant prior injury to the index knee within 12 months prior to screening
- •Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Plavina cream (Drug)
结局指标
主要结局
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
时间窗: 3 months
VAS 0-100 mm. using questionnaire
次要结局
- WOMAC and(3 months)
研究者
Weerachai Kosuwon
Department of Orthopedics, Faculty of Medicine
Khon Kaen University