CTRI/2025/03/082495已完成不适用
Efficacy of CL22202 in improving Knee Osteoarthritis: A Randomized, Double-Blind, Placebo Controlled Parallel-Group Study.
CLS Pvt Ltd2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline to the end of the study period in : Total WOMAC score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of CL22202 in improving Knee Osteoarthritis. A total of 100 Ambulatory, male and female subjects aged between 45 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either CL22202 - 200 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 120 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL22202 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ambulatory, male and female subjects aged 45-70 years with a Body Mass Index (BMI) of 22 to 29 kg/m².
- •2.Subjects diagnosed with Knee osteoarthritis grade II of Kellgren and Lawrence based on X-ray.
- •3.Subjects experiencing knee pain of 40-70 mm on a 100 mm visual analog scale (VAS).
- •4.Willing to refrain from using glucosamine, chondroitin, MSM, boswellia, turmeric, any other joint supplements, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDs (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
- •5.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
- •6.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •7.Subjects to discontinue the use of supplementations including vitamins, any other joint supplements, herbals, or other topical applications.
- •8.Agree to participate in the study through a written informed consent.
- •9.Willing to comply with all study-related activities.
- •10.No history of rheumatoid arthritis.
- •11.No bilateral end-stage knee OA.
排除标准
- •1.Previous injury and/or surgery to the knee.
- •2.Subjects who underwent treatment for COVID-19 within the last 3 months or tested positive during the study.
- •3.Expectation of surgery during the study period.
- •4.Subjects with uncontrolled Diabetes (FPG greater than 126 mg/dL) and Hypertension (Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg).
- •5.Subjects suffering from COPD or with a history of any respiratory or breathing disorders.
- •6.Subjects who have used any immunosuppressive drugs in the last 6 months (including steroids or biologics) or those with a history of immune system and autoimmune disorders or diseases, including Systemic Lupus Erythematous (SLE).
- •7.Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- •8.Subjects with known allergies to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, or who have a suspected hypersensitivity, allergy, or sensitivity to herbal products.
- •9.Subjects who have taken acetaminophen/paracetamol, ibuprofen, aspirin, or other NSAIDs, or any herbal products within 7 days prior to the screening visit (visit 1).
- •10.Subjects who have taken any corticosteroid, indomethacin within 1 month prior to enrollment, or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
- •11.History of congestive heart failure or any vascular conditions.
- •12.Subjects with HIV positive status.
- •13.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- •14.Alcohol intake greater than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers (greater than 5 cigarettes per day).
- •15.History of psychiatric disorders that may impair the ability of subjects to provide written informed consent.
- •16.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
- •17.History of heart, liver, lung cancer or chronic diseases.
- •18.Allergies to any ingredient in the investigational products.
- •19.Subjects with bilateral knee replacements.
- •20.Subjects currently engaged in a weight loss program or using weight loss medications.
- •21.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
结局指标
主要结局
Change from baseline to the end of the study period in : Total WOMAC score
时间窗: Days 1, 14, 30, 60, 90 and 120
次要结局
- Serum Biomarkers (hs-CRP, TNF-alpha, MMP-3, COMP-1 and IL-6)
- Urinary CTX-II (normalized by Creatinine)
- Total Anti-Oxidant Capacity (TAC)
- Primary Knee flexion range of motion
- Isometric Knee torque (using EasyForce dynamometer)
- Perceived Stress Scale (PSS-10)
- Athens Insomnia Scale (AIS)
- Kellgren and Lawrence grade
- Quality of life Short Form-36 (SF-36) questionnaire
- Change from baseline to the end of the study period in:
- Pain using Visual Analogue Scale (VAS) - 100 mm
- Lequesne’s Functional Index (LFI)
- Six-minute walk test (SMWT)
- Chair stand test (30SCST)
- Memory questionnaire (Mini-Cog©)
- Use of Rescue medication(Days 1, 14, 30, 60, 90 and 120)
研究者
Dr Annavarapu Tirupathi Rao
CLS Pvt Ltd
研究点 (2)
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