CTRI/2009/091/000992已完成3 期
A double blind, placebo controlled, randomized trial to determine the effectiveness and safety of bovine bone collagen peptide as add-on nutritional supplement in management of subjects with knee joint osteoarthritis
MS Nitta Gelatin India Limited Cochin INDIA0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •?Subjects of both sexes between 30 and 65 years of age.
- •?Subjects who are willing to give informed consent.
- •?Subjects who are willing to comply with the study procedure.
- •?Subjects having a medical history of knee joint osteoarthritis.
- •?Subjects who are already not on NSAIDs 7 days prior to screening
- •?Subjects willing to use pain relieving medications as prescribed by the physician in the trial.
- •?Subjects diagnosed with knee joint osteoarthritis fulfilling the ACR classification criteria for knee joint osteoarthritis.
- •?Subjects with a pain (VAS score ≥ 4) in one or both knees on walking during the 24 hours preceding recruitment.
- •?Subjects with moderate radio graphic evidence by Kellgren - Lawrence grade 2 to grade 4.
- •?Otherwise, the subject in generally good health as judged by investigator
排除标准
- •?Subjects who are diagnosed with OA excepting knee joint osteoarthritis.
- •?Subjects who are suffering from systemic diseases.
- •. Subjects with BMI of more than 35
- •?Subjects with known history of hypersensitivity or intolerance to NSAIDs and any other analgesic medicine.
- •?Subjects who are incapacitated or bound to wheel chair or bed and unable to carry out self care activities.
- •?Subjects who have undergone treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding the study.
- •?Pregnancy, lactation and women of child bearing potential not following an acceptable contraceptive measure.
- •?Subjects with pre-existing or recent onset of demyelinating disorders or diabetes.
- •?Subjects with presence or history of active peptic ulcer in the preceding 5 months or bleeding ulcer at anytime in the past.
- •?Subjects suffering or having a previous medical history of gout.
- •?Subjects who have evidence of severe renal, hepatic or hemopoietic disease or moderate to severe cardiac conditions revealed by laboratory investigations or other tests.
- •?Subjects who used Ayurvedic formulation or any form of CAM (Complementary Alternative Medicine) therapy in the preceding 2-3 months
- •?Subjects who are using steroids, antipyretics, tranquilizers and hypnotics during the trial.
- •?Subjects who are using concurrent pain relieving medication other than prescribed in the trial.
- •?Subjects using glucosamine, chondroitin, doxycycline or any other anti-osteoarthritis preparation within 14 days prior to randomization.
- •?Subjects who underwent arthroplasty for the knee.
- •?Subjects with history of chronic alcoholism or subjects who consumed alcohol 48 hours prior to enrollment.
- •?Subjects having a history of smoking 5 cigarettes or more per day
- •?Subjects who participated in any other clinical trial 3 months prior to this trial.
- •?Subjects who are unwilling or unable to comply with the study procedures.
- •?Subjects, for any reason who are considered to be unsuitable candidates by the investigator.
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