A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Unstergen from Titan Biotech Limited as a Nutritional Supplement in Adult Subjects with Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 1. WOMAC: Reduction by greater than equal to 10 total score from baseline
研究概览
简要总结
Study Design : A Double Blind, Prospective, Randomised,Comparative, Placebo Controlled Clinical Study.
Indication : Osteoarthitis of Knee Unspecified,Osteoarthitis of Hip Unspecified
Investigational Product : Unstergen Capsules (40 mg Chicken Collagen) Comparator: Placebo Dose : 40mg Capsule Dosage : One capsule to be consumed once a day for 90 days
Subject Population : Adult subjects between the ages of 30 and 65years with confirmed diagnosis or known history of OsteoArthritis(both ages and all sexes inclusive) Number of Subjects : 45 Evaluable Subjects
**Treatment Arms Treatment Arm I :**Unstergen Capsules Treatment Arm II : Placebo : 16 Subjects Treatment Duration : 90 days
Assessments 1.WOMAC : Day1, Day 45,Day 90 2. Pain NRS Scale : Day 1, Day 45,Day 90 3. Quality of Life Questionnaire : Day 45, Day 90 4. Global Rating of Change Scales : Day 90
Background of the study: Osteoarthritis (OA) is themost prevalent chronic joint disease, affecting 30–50% of adults over 65 years.The burden of disease is growing in relation to aging and the increasing levelsof obesity in the world population. It is a heterogeneous disease for which ageand obesity have been recognized as prominent risk factors; however, additionalcritical factors have been identified, including genetics, mechanical stress,injury and hormonal modifications. All joints may be affected but the mostcommon localizations are the knee and hip.
Purpose of the Study : Collagen is the most abundant protein foundin animals and is the key structural component in the connective tissues ofcartilage, tendons, and ligaments, as well as in a multitude of organs such asblood vessels, bones, lung, heart, kidney, liver, teeth, and skin. Collagensupplements are intended to replenish your body’s natural supply of theprotein. Dietary intake of collagen peptide has been shown to reduceOsteoarthritis. This clinical study is done to evaluate the safety and Effectiveness of “Unstergen Capsules â€from Titan Biotech Limited as a Nutritional Supplement inAdult Subjects with Osteoarthritis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subject between the ages of 30 and 65 years with confirmed diagnosis or known history of OsteoArthitis (both ages and sexes inclusive)
- •Subjects who have a pain score 5-7 on a 10point NRS at the time of screening in a minimum of one joint .
- •Subjects who are willing to abstain form the use of herbal, allopathic or other nutritional supllements that are indicated at improving osteoarthitis ,Bone health,joint pain.
- •Subjects who are ambulatory requiring but not currently receiving or not satsified with anti -inflammatory or anti analgesic drugs.
- •Subjects who are willing to give infromed consent for participation ,able to comphrend and understand the responsibilites during screening and treatment period.
- •Subject who are willing not to participate in any other clinical trail during participation in the current trail.
排除标准
- •Subjects with known hypersensitivity to the ingredients of theinvestigational product.
- •Subjects who are on collagen supplements in any form.
- •Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment.
- •Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment.
- •Subjects with immunucompromised state complications.
- •History of surgery in the target joint.
- •Planned surgery on any lower extremity joint.
- •Clinically significant venous or lymphatic stasis present in the leg(s).
- •Any musculoskeletal condition that would impede measurement of efficacy at the target joint.
- •Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product.
- •Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •Subjects on remission from cancer of any type less than 5 years at the time of screening.
- •Subjects who are planning a pregnancy and/or currently breastfeeding.
- •Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g. planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
结局指标
主要结局
1. WOMAC: Reduction by greater than equal to 10 total score from baseline
时间窗: 1. WOMAC : Day 1, Day 45,Day 90 | 2. Pain NRS Scale : Day 1, Day 45,Day 90 | 3. Quality of Life Questionnaire : Day 45, Day 90 | 4. Global Rating of Change Scales : Day 90
2. Pain NRS Scale : Reduction by greater than equal to 2 scores from baseline
时间窗: 1. WOMAC : Day 1, Day 45,Day 90 | 2. Pain NRS Scale : Day 1, Day 45,Day 90 | 3. Quality of Life Questionnaire : Day 45, Day 90 | 4. Global Rating of Change Scales : Day 90
3. Quality of Life Questionnaire : Total score of greater than equal to 15 by end of the study.
时间窗: 1. WOMAC : Day 1, Day 45,Day 90 | 2. Pain NRS Scale : Day 1, Day 45,Day 90 | 3. Quality of Life Questionnaire : Day 45, Day 90 | 4. Global Rating of Change Scales : Day 90
4. Global Rating of Change Scales : Score of greater than equal to +2 scores based on improvement in X RAY (Cohort Analysis)
时间窗: 1. WOMAC : Day 1, Day 45,Day 90 | 2. Pain NRS Scale : Day 1, Day 45,Day 90 | 3. Quality of Life Questionnaire : Day 45, Day 90 | 4. Global Rating of Change Scales : Day 90
次要结局
- None. Not Applicable.(None. Not Applicable.)