NCT05369780Unknown不适用
A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide On Knees, Hips, and Ankle Pains In Adults With Osteoarthritis
Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.0 个研究点目标入组 160 人开始时间: 2022年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 主要终点
- Amelioration on Knee Pain
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of Hydrolyzed collagen peptides on joint pain, stiffness and physical function in adults with osteoarthritis who have complaints on knee joints together with hip and ankles. The assessment of improvements on volunteers' quality of life, and safety and tolerability of the product is the other objective of this placebo-controlled, randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female individuals with osteoarthritis on knee who are aged between 45-60 years old,
- •Who are not drug-naïve to osteoarthritis and related conditions,
- •Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
- •Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,
- •Volunteers who have understanding of the study and agreement to give a written informed consent.
排除标准
- •Who have atopic constitution or asthma and/or known allergy for bovine derived collagen products and/or other any of the excipients of the product.
- •Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
- •Who have an active rheumatoid arthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
- •Who have Diabetes Mellitus.
- •Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
- •Who have current participation in another clinical study, or participation in a relevant study within 3 months.
- •Who have any history or presence of serious or life-threatening conditions of cardiovascular, neurological, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
- •Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
- •Who are planned to go or already went under a joint-related reconstructive surgery,
- •For female volunteers, who had undergone, or planned to undergo, pregnancy or breastfeeding.
- •Who have current or regular intake of NSAIDS, contraceptives, hormones, obesity drugs, absorption inhibitors or antidepressants
- •Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.
- •Who have history of drug abuse.
- •Who have relationship to the investigator.
- •Who are not suitable to any of inclusion criteria.
- •Who have history of difficulty of swallowing.
结局指标
主要结局
Amelioration on Knee Pain
时间窗: 2 months
Amelioration on knee joint pain, stiffness and physical function according to WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score.
次要结局
- Amelioration on Hip Pain(2 months)
- Amelioration on Ankle Pain(2 months)
研究者
相似试验
招募中
不适用
Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.Pain, AcutePain, ChronicKnee InjuriesKnee OsteoarthritisNCT05917925Francisco Javier Martínez Noguera80
已完成
不适用
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and WomenOsteoarthritisOsteoarthritis, HipOsteoarthritis, KneeNCT05070871Hofseth Biocare ASA98
已完成
不适用
Effects of Collagen Peptide Supplementation on Muscle and Tendon Damage and FunctionExerciseHealthy Male SubjectsNCT05425407KU Leuven22
Unknown
不适用
Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult FemalesSkinSkin ManifestationsWrinkleNCT05235997Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.120
已完成
不适用
Hydrolyzed Collagen and Undenatured Collagen Type II in OA KneeOsteo Arthritis KneeNCT06229951Prince of Songkla University68