PACTR201705002287258已完成未知
Effectiveness of a Cucumis sativus extract versus Glucosamine-Chondroitin used as placebo in the management of osteoarthritis: a randomized controlled trials
未提供0 个研究点目标入组 150 人开始时间: 2017年5月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 150
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
- 年龄范围
- 40 Year(s) 至 75 Year(s)（—）
- 性别
- All
入选标准
- •¿ Ambulatory, 40¿75 years of age, with a BMI of 18 to 30 kg/m2
- •¿ Females of childbearing age must agree to use a medically approved form of birth control and have a negative urine pregnancy test result throughout the study
- •¿ Female subjects of limited to no childbearing potential must be amenorrheic for at least 1 year or have had a hysterectomy, a bilateral oophorectomy, or both
- •¿ Unilateral or bilateral OA of the knee for greater than 3 months plus a Kellgren and Lawrence radiographic grade of 2 or 3
- •¿ VAS score during knee movement between 40¿70 mm after 7 day withdrawal of excluded medications
- •¿ LFI score between 6¿10 points after 7 day withdrawal of excluded medications
- •¿ Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator
- •¿ Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol
- •¿ Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription) during the entire trial other than acetaminophen (paracetamol) as rescue medication
- •¿ Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the trial
排除标准
- •¿ History of hypersensitivity to the rescue medication or any of the products used in the study
- •¿ History of hypersensitivity to eggs, chicken or fowl, or shellfish
- •¿ History of inflammatory arthropathy, severe RA, OA (VAS score greater than 70), or Systemic Lupus Erythematosus
- •¿ Hyperuricemia (>440 ¿mol/L), past history of gout, or both
- •¿ Anticipation of surgery within the next 4 months
- •¿ Recent injury in the target knee (past 4 months)
- •¿ History of use for corticosteroid, indomethacin, glucosamine & chondroitin within 3 months of Visit 2; intra-articular treatments, including injections of corticosteroid or hyaluronic acid; consumption of Omega 3 fatty acids dietary supplements within 6 months preceding the treatment period (a 2-week washout period is allowed for subjects taking omega 3 fatty acid supplements)
- •¿ History of congestive heart failure
- •¿ Anticipated problems with product consumption
- •¿ Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years
- •¿ High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.)
- •¿ Females who are pregnant or lactating or planning to become pregnant
- •¿ History of any mental illness that might impair the ability of subjects to provide a written informed consent
- •¿ Consumed acetaminophen (paracetamol), ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit
- •¿ Participation in any clinical trials within 30 days prior to first visit
研究者
相似试验
已完成
4 期
Curcumin effect on delayed onset muscle sorenessIRCT20191013045089N1Shahid Beheshti University of Medical Sciences15
已完成
不适用
To compare efficacy of Turmeric, Friendly Bacteria, and Fluoride based mouth rinses in childreCTRI/2022/07/043936SGT University36
Enrolling By Invitation
1 期
A randomized clinical trial assessing efficacy and safety of Curcuma comosa extract on vasomotor symptomsHot flashes SafetyCurcuma comosaHotflashesSafetyPerimenopauseClimacteric symptomsMenopauseTCTR20140818001Agricaultural research development agency (Public organization)40
招募中
1 期
Investigating the effect of suckable form of curcumin and ginger mouthwash on oral health and sense of tasteIRCT20230625058578N1Artesh University of Medical Sciences99
招募中
3 期
Evaluation the effect of Crocus sativus extract on prevention of nephropathy induced by coronary angiograpyIRCT20170112031893N6Ghoum University of Medical Sciences120