Evaluation of Biomarkers in Patients of Osteoarthritis treated with Terminalia chebula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Modified Western Ontario and McMaster Universities (mWOMAC) Index is a disease specific outcome measure for osteoarthritis. It has three subscales assessing, Pain –A, Stiffness-B and Physical Function for Disability-C. Primary outcome is the reduction in modified WOMAC total score (A+B+C) from baseline to the end of treatment at week 12.
研究概览
简要总结
Joint discomfort may be an early indication ofonset of osteoarthritis, which is anon-inflammatory degenerative disorder of joints characterized by progressivedeterioration of the articular cartilage and formation of new bone (osteophytes).The use of NSAIDs for symptomatic relief of joint discomfort is limitedby their gastrointestinal adverse effects. Terminaliachebula is an Ayurvedic preparation that has shown analgesic and anti-inflammatoryeffect in animals. A Proprietary ChromiumComplex (PCC) was also shown to be efficacious in reducing pain in dogs withmoderate osteoarthritis. Hence, the current study was planned to evaluate theanalgesic property of an aqueous extract of T.chebula (TCE), a combination of TCEand PCC and PCC alone on outcome parameters of efficacy and safety in patientswith discomfort of the knee joint.
While nonsteroidal anti-inflammatory drugs(NSAIDs) are effective for thetreatment of pain and are overall well tolerated, their use is associated withpotentially severe adverse effects. Gastrointestinal (GI) complications fromNSAIDs include dyspepsia, ulcers and bleeding. Epidemiologicstudies suggest that use of NSAIDs increases the risk of GI complications twoto six times. A safer alternative treatment would thereforebe beneficial in such cases. Naturalproducts derived from plants offer such an alternative. Terminaliachebula is a plant commonly used in Ayurvedic medicinefor the treatment of arthritis, gout, paralysis. Both anecdotal evidenceand recent studies haveimplicated the potential of this herbal remedyfor the treatment of painful, chronic arthritic type conditions in experimentalmodels. Animal studies have demonstratedthe anti-inflammatory activity of theethanolic extract of T.chebula fruits and the probable mechanismof action was postulated to be due toinhibition of COX-1, COX-2 and 5-LOX enzymes. Another mechanismwhich can be attributed to Terminalia chebula’santi-inflammatoryaction could be down regulation of NFkB. Only one human studyhas demonstrated the anti-inflammatory properties of a polyherbal formulationfor allergic rhinitis, containing T.chebulaas one of several ingredients.
Proprietary ChromiumComplex (PCC) is a complex of ChromiumIII with the polyphenolic compunds of Phyllanthusemblica fruit extract and purified Shilajit, a natural product from theHimalays, containing dibenzo-α-pyrones (DBPs), DBP-chromoproteins and fulvicacids. A recent study has shown that this complex decreased pain associatedwith osteoarthritis in dogs. Nohuman clinical studies of T. chebula or PCC in subjects with joint painand discomfort have been reported so far. Thus, the present clinical study wasaimed at evaluating the efficacy and safety of an aqueous extract of Terminaliachebula at two different doses, Proprietary Chromium Complex alone and acombination of both in human volunteers with joint discomfort.
A total of 100 patients with knee jointdiscomfort were randomizedto either of the five treatment groups -TCE500 mg BID*,* TCE500mg BID*+* PCC 400mcg OD*,* PCC 400mcgOD alone*,* placeboand TCE 250 mg BID*,* in a double blinded manner. Assessmentof symptoms of knee joint pain& discomfort was done by modified Western Ontarioand McMaster Universities Arthritis Index (mWOMAC) and Knee Swelling Index(KSI), Visual Analogue Scale (VAS) was used forsubjective assessment of pain, stiffness and disability. Tolerability wasassessed by the incidence of adverse effects in the treatment groups. Theduration of the study was 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender aged between 40 and 70 years, suffering from joint discomfort for at least 6 months duration, taking only an OTC analgesic medication occasionally and meeting the American Rheumatism Association(ARA) functional class I to III and radiological evidence of osteoarthritis, patients who have grade II to IV of the Kellgren and Lawrence scale in the knee joint X-ray and who record baseline pain scores of at least 40 mm on the Visual Analogue Scale(VAS), monitored at baseline visit, subjects agreeing to discontinue any use of analgesics during the study.
排除标准
- •Patients with severe osteoarthritis (ARA functional class IV), Patients with radiological grading.
- •Kellgren and Lawrence scale ranging from grade 0 to grade I, patients on alternative system of medicine, any psychiatric disorder or who have been using systemic/intra-articular steroids within 12 weeks and hyaluronic acid in the last 9 months, or potential candidates for imminent joint replacement, Patients with uncontrolled hypertension or diabetes, hepatic or renal impairment, pregnant or lactating females, or with a recent trauma of the involved knee.
结局指标
主要结局
Modified Western Ontario and McMaster Universities (mWOMAC) Index is a disease specific outcome measure for osteoarthritis. It has three subscales assessing, Pain –A, Stiffness-B and Physical Function for Disability-C. Primary outcome is the reduction in modified WOMAC total score (A+B+C) from baseline to the end of treatment at week 12.
时间窗: week 4, week 8 and week 12.
次要结局
- VAS based assessment of Pain,Disability, and Stiffness subscales.(Knee Swelling Index as measured by signal joint knee circumference.)