An Open Label, Randomized, single center Clinical Trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in subjects with osteoarthritis of knee joints.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the efficacy of CurcuBoost® therapy in standard regimen based on
研究概览
简要总结
It is an Open Label, Randomized, single center Clinical Trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in subjects with osteoarthritis of knee joints.
OA(Osteoarthritis) is currently considered as a disease caused by dynamic reaction of joint to a variety of biomechanical and biochemical factors. It occurs when degradation of cartilage exceeds repair. The ligaments surrounding the joint become lax, joint capsule thickens, joint fluid becomes less viscous, muscle undergo wasting and become weak. Cartilage has no pain sensation. Pain in OA arises from bone and other structures within and around the joint. Crystals and swelling inside the joint are important causes of pain in OA.
CurcuBoost® employs advanced formulation technology to enhance curcumin’s bioavailability, potentially amplifying its therapeutic benefits in OA management. Administering CurcuBoost® alongside SOC treatments could provide a synergistic effect, improving pain relief, joint function, and overall patient outcomes while minimizing reliance on high-dose NSAIDs and associated adverse events.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •To participate in the study, subjects must meet the following criteria:
- •Signed Patient Information Sheet and Informed Consent Form to participate in the study.
- •Men and women aged 40 to 75 years (inclusive)
- •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.
- •Pain during walking in target knee joint according to VAS greater than 40 mm (moderate or severe pain when walking).
- •Patients with bilateral osteoarthritis of knee joints can be included in the study, but data on efficacy and safety must be collected for the most painful knee joint (target knee).
- •According to VAS, the level of pain in the contralateral knee joint must be less than in the target knee joint (less than 40 mm), if the pain intensity is the same in both joints, joint with a higher grade according to Kellgren-Lawrence classification is chosen.
- •If both knee joints are equally painful and have the same stage according to the Kellgren-Lawrence classification, then the knee joint is chosen at the discretion of the investigator.
- •Need of daily/ long-term use of NSAIDs (at least 30 days) over the past three months.
- •Consent of patients, including men and women with childbearing potential (who have not undergone surgical sterilization or who have been in menopause less than 2 years), to use adequate contraception methods during the entire study and 3 months after the end of therapy.
- •Adequate contraceptive methods include a condom or diaphragm (barrier method) with a spermicide.
排除标准
- •A subject will be considered unsuitable for the study if they meet any one of the following criteria:
- •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 effectiveness or pain in the knee joint.
- •History of septic arthritis of any joint or suspected subacute infectious inflammation in the target joint.
- •Surgical treatment of a targeted knee in history.
- •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 (hyperparathyroid osteodystrophy, malabsorption syndrome, osteomalacia, osteogenesis imperfecta, etc.).
- •Current or 12 months prior to screening 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 greater than 180 mm Hg and diastolic blood pressure greater than 110 mm Hg, pulmonary embolism or deep vein thrombosis.
- •Subjects with BMI greater than equal to 40 kg/m2
- •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, hemophilia, 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).
- •Drug or alcohol abuse at the time of screening or in the past 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: • Administration of systemic glucocorticoids within 2 months prior to screening.
- •• 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 sulfate, 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.
- •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.
结局指标
主要结局
To determine the efficacy of CurcuBoost® therapy in standard regimen based on
时间窗: To determine the efficacy of CurcuBoost® therapy in standard regimen based on | change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in | patients with osteoarthritis of knee joints in Indian population.
change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in
时间窗: To determine the efficacy of CurcuBoost® therapy in standard regimen based on | change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in | patients with osteoarthritis of knee joints in Indian population.
patients with osteoarthritis of knee joints in Indian population.
时间窗: To determine the efficacy of CurcuBoost® therapy in standard regimen based on | change in the WOMAC (pain) scale on Week 8 compared to baseline (Week 0) in | patients with osteoarthritis of knee joints in Indian population.
次要结局
- The secondary endpoint is to evaluate theChange in WOMAC scores (pain, stiffness, function).(• Efficacy evaluation based on OMERACT-OARSI responder criteria (in)
研究者
Dr Lokesh Bansal
Panchsheel Hospitals Pvt. Ltd.