CTRI/2026/04/108650尚未招募不适用
A Prospective, Randomized, Open Label, Parallel GroupComparative Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Xtagen SoloTM in Subjects with Osteoarthritis of Knee Joints in Indian Population.
Xania International DGMR LLC FZ4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2027年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 4
研究概览
简要总结
This is a randomized, open-label, parallel-group, active-controlled, multicentric clinical study in India to evaluate the efficacy and safety of Xtagen Solo administered for 45 days as an add-on to standard of care in adult patients with mild to moderate osteoarthritis of the knee. Standard of care includes oral NSAIDs for 10 days and physical therapy for 45 days. Eligible patients aged 30 to 75 years with osteoarthritis of the knee diagnosed as per American College of Rheumatology criteria and Kellgren-Lawrence Grade II or III will be randomized in a 1:1 ratio to receive either Xtagen Solo plus standard of care or standard of care alone for 45 days. The total study duration per subject will be 6 weeks. Study visits include screening, baseline and randomization, Week 3 assessment, and Week 6 end-of-study assessment. Efficacy will be assessed primarily using WOMAC scores. Safety will be evaluated through adverse event monitoring, vital signs, laboratory investigations, and assessment of gastrointestinal tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women aged more than or equal to 30 to less than or equal to 75 years (both inclusive).
- •Diagnosis: Diagnosis of osteoarthritis of the knee joint established in accordance with the classification criteria of the American College of Rheumatology (ACR) and with X-ray signs of grade II or III according to the Kellgren-Lawrence classification.
- •Disease Activity: The WOMAC pain subscale score greater than or equal to 2 in the index knee or a VAS pain score between 40 mm and 90 mm in the index knee (with less than or equal to 30 mm in the contralateral knee).
- •Regular use of oral NSAIDs for knee pain on greater than or equal to 15 days per month in the 3 months prior to screening.
- •Consent: Able and willing to provide written informed consent.
- •Compliance: Willing to comply with study visits, treatment, and procedure.
- •Women patients willing to use effective methods of contraception throughout the study duration.
排除标准
- •Subjects will be excluded if CRP is more than 10 mg/L and/or ESR more than 30 mm/hr at screening, unless the principal investigator determines that these elevated values are due to a temporary, non-inflammatory condition and not related to an underlying rheumatologic disorder.
- •Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m
- •Concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis etc.).
- •Significant (requiring surgical treatment) valgus or varus deformity of the knee joint, ligamentous laxity, or destruction of the meniscus.
- •Concomitant osteoarthritis of the hip and/or ankle joints, of severe grade, which may make it difficult to assess the pain in the target knee joint.
- •History of septic arthritis of any joint or suspected subacute infectious inflammation in the target knee joint.
- •History of surgery of the targeted knee joint.
- •Planned surgery on any joint of the lower extremities during the study.
- •Lymphovenous insufficiency of the lower limbs, grade III.
- •Diseases and concomitant conditions affecting the structure and density of bone tissue (osteodystrophy due to hyperparathyroidism, malabsorption syndrome, osteomalacia, osteogenesis imperfecta, etc.).
- •History or current severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure more than 180 mm Hg and diastolic blood pressure more than 110 mm Hg, pulmonary embolism or deep vein thrombosis.
- •History of Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c more than 8.5 percent and/or fasting plasma glucose more than 180 mg/dl at screening or episodes of severe hypoglycaemia 1 month); HbA1c report within 60 days is acceptable.
- •Subjects with BMI more than or equal to 40 kg/m
- •Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor.
- •Diseases manifested by increased bleeding (hemorrhagic diathesis, haemophilia, thrombocytopenia, etc.), or conditions with a high risk of bleeding.
- •Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study.
- •Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening.
- •HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history.
- •Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment).
- •History or current use of Drug of abuse, excessive alcohol intake, which in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
- •Pregnant or lactating women or women planning a pregnancy during the clinical study.
- •Hypersensitivity to any of the components of the investigational product in medical history.
- •Prior therapy with the following drugs: • Intra-articular administration of any medicinal products within 4 weeks prior to screening.
- •• Administration of oral slow-acting products, including dietary supplements for the treatment of osteoarthritis of the knee joint (chondroitin sulfate, glucosamine sulphate, piascledine, diacerein) within 3 months prior to screening.
- •• Administration of bisphosphonates, strontium ranelate, hormone replacement therapy, parathyroid hormone preparations, preparations of monoclonal antibodies to RANKL, active metabolites of vitamin D within 12 months prior to screening.
- •• Administration of other products that can affect the metabolism of bone tissue (antiepileptic preparations, anabolic steroids, etc.) 4 weeks (28 days) prior to screening.
- •Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study
- •Allergy/Intolerance: Known hypersensitivity to Xtagen SoloTM or any investigational products ingredients.
- •Other conditions: Any psychiatric, neurological, or systemic condition that in the investigator’s opinion may interfere with study participation or data interpretation.
研究者
Dr Veena RM
CliniExperts Research Services Pvt. Ltd.
研究点 (4)
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