CTRI/2026/01/101526尚未招募不适用
A Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Efficacy of LN21194 in Improving Knee Osteoarthritis.
Laila Nutra Private imited1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月30日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Pain using Visual Analogue Scale (VAS) - 100 mm
研究概览
简要总结
The Purpose of the study is to evaluate the efficacy of LN21194 in improving knee osteoarthritis. A total of 80 male and female subjects aged between 40 and 75 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 LN21194-200mg or Placebo arm at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water for 30days. Apart from primary and secondary outcomes, the study will also record the vital sign and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN21194 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, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Ambulatory, male and female subjects aged 40-75 years with a Body Mass Index (BMI) of 22 to 29 kg/m².
- •Subjects diagnosed with Knee osteoarthritis grade II of Kellgren and Lawrence based on X-ray.
- •Subjects experiencing knee pain of 40-70 mm on a 100 mm visual analogue scale (VAS).
- •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.
- •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.
- •Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •Subjects to discontinue the use of supplementations including vitamins, any other joint supplements, herbals, or other topical applications.
- •Agree to participate in the study through a written informed consent.
- •Willing to comply with all study-related activities.
- •No history of rheumatoid arthritis.
- •No bilateral end-stage knee OA.
排除标准
- •Previous injury and/or surgery to the knee.
- •Subjects who underwent treatment for COVID 19 within the last 3 months or tested positive during the study.
- •Expectation of surgery during the study period.
- •Subjects with Diabetes (FPG greater than 126 mg/dL) and Hypertension (Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg).
- •Subjects suffering from COPD or with a history of any respiratory or breathing disorders.
- •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).
- •Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- •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.
- •Subjects who have taken acetaminophen or paracetamol, ibuprofen, aspirin, or other NSAIDs, or any herbal products within 7 days prior to the screening visit (visit 1).
- •Subjects who have taken any corticosteroid, indomethacin within 1 month prior to enrollment, or intra-articular treatment or injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
- •History of congestive heart failure or any vascular conditions.
- •Subjects with HIV positive status.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- •Alcohol intake more than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers (more than 5 cigarettes per day).
- •History of psychiatric disorders that may impair the ability of subjects to provide written informed consent.
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
- •History of heart, liver, lung cancer or chronic diseases.
- •Allergies to any ingredient in the investigational products.
- •Subjects currently engaged in a weight loss program or using weight loss medications.
- •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 in Pain using Visual Analogue Scale (VAS) - 100 mm
时间窗: Screening, Baseline, Day 5, Day 15 and Day 30
次要结局
- Change in WOMAC Total & subscales (pain, stiffness, physical function)(Baseline, Day 5, Day 15 and Day 30)
- Change in Lequesne’s Functional Index (LFI)(Baseline, Day 5, Day 15 and Day 30)
- Change in Six Minute Walk Test (SMWT)(Baseline, Day 5, Day 15 and Day 30)
- Change in Chair stand test (30s CST)(Baseline, Day 5, Day 15 and Day 30)
- Change in Primary Knee flexion range of motion(Baseline, Day 5, Day 15 and Day 30)
- Change in Isometric knee torque using Easy force dynamometer(Baseline, Day 5, Day 15 and Day 30)
- Change in Psychological General Wellbeing Index (PGWBI)(Baseline, Day 5, Day 15 and Day 30)
- Change in PGA & SGA (Physician Global Assessment & Subjective Global Assessment)(Day 5, Day 15 and Day 30)
- Change in Serum Biomarkers (hs CRP, IL-6 and PGE-2)(Baseline and Day 30)
- Use of rescue medication(Baseline, Day 5, Day 15 and Day 30)
研究者
Dr Vikram Nigam
Swaroop Rani Hospital,
研究点 (1)
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