CTRI/2009/091/000993已完成3 期
A double-blind, placebo-controlled, randomized trial to determine the effectiveness and safety of Pork Skin Collagen Peptide (SCP- α) as add-on nutritional therapy in 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.
研究者
相似试验
进行中（未招募）
1 期
Safety and efficacy of EMA401 in patients with painful diabetic neuropathy (PDN)EUCTR2016-000281-39-FIovartis Pharma AG400
进行中（未招募）
1 期
Safety and efficacy of EMA401 in patients with painful diabetic neuropathy (PDN)Painful Diabetic NeuropathyMedDRA version: 20.0 Level: LLT Classification code 10067547 Term: Diabetic peripheral neuropathic pain System Organ Class: 100000004852EUCTR2016-000281-39-HUovartis Pharma AG400
进行中（未招募）
1 期
Safety and efficacy of EMA401 in patients with painful diabetic neuropathy (PDN)EUCTR2016-000281-39-BEovartis Pharma AG400
进行中（未招募）
不适用
A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut’s Efficacy and Safety for treating peanut allergy in children and adults.EUCTR2011-002550-32-PLDBV Technologies220
进行中（未招募）
不适用
A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut’s Efficacy and Safety for treating peanut allergy in children and adults.Treatment of peanut allergy in adults and children age 6 years and older with documented hypersensitivity to peanut. The induction of clinical desensitization to peanut in patients allergic to peanut should reduce the risk of anaphylaxis in case of accidental exposure to small amounts of peanut proteins.MedDRA version: 16.0Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870EUCTR2011-002550-32-NLDBV Technologies SA220