A Single Center, Randomized, Double blind, Placebo Controlled Pilot Study to Evaluate the Efficacy, Safety and Tolerability of Turmeric Lemonade Energy Drink (Bioactive Curcumin Plus Green Tea Plus Ginger Plus Lemon Plus Lime) manufactured by Golden Tiger Life Corp in the Treatment of Patients with Moderate Osteoarthritis of Knee.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- 1. Mean Change from Baseline to End of Treatment in Knee injury and osteoarthritis outcome score (KOOS).
研究概览
简要总结
Osteoarthritis (OA) is a common, chronic, progressive, skeletal, and degenerative disorder that commonly affects the knee joint which causes the disability of elderly people in developed countries. Curcuma longa, the rhizome from which the curcuminoids are extracted and purified, has been traditionally used as an anti-inflammatory agent in many Ayurvedic medicines for several years. Curcuminoids possess significant anti-inflammatory activity by interacting with many inflammatory processes. Several OA trials have been conducted to evaluate the safety and efficacy of curcumin-based formulations in alleviating the symptoms of pain and inflammation associated with OA. The results of these studies have indicated that the natural approach was superior to prescription drugs on pain parameters and if given on top of prescription medicine, it reduced the symptoms of knee OA. Decreased joint pain and improvement in joint function were observed in OA patients involved in the studies. A significant improvement of clinical and biochemical endpoints was also observed with the use of bioavailable curcumin. The proposed study is to validate the clinical data for the efficacy, safety, and tolerability of Turmeric Lemonade Energy Drink (Bioactive Curcumin + Green Tea + Ginger + Lemon + Lime) in subject with moderate OA of Knee.
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
- 38.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide voluntary written informed consent and comply with all study procedures.
- •Confirmed diagnosis of unilateral or bilateral knee Osteoarthritis as per clinical American College of Rheumatology (ACR) criteria Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age greater than 50 years, morning stiffness less than 30 min, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
- •Subject with confirmed diagnosis of unilateral or bilateral knee Osteoarthritis for at least greater than 3 months.
- •Subject with index knee joint pain rated less than equal to 44 on a 100 point pain KOOS scale in one or both knees during enrolment.
- •Subject who is able to walk for at least 6 minutes at a moderate to brisk pace.
- •Subjects having mild to moderate pain not adequately or completely controlled with antiinflammatory drugs.
- •Results of screening tests are within normal range or considered not clinically significant by the Investigator.
- •Subject willing to be involved in regular physical activity such as walking, climbing stairs, recording forms, eating, exercise behaviors, etc.
- •Subjects willing to refrain from using ibuprofen, aspirin or other NSAIDs (other than acetaminophen or paracetamol as rescue) and or any other pain reliever including topical application (OTC or prescription), any herbal or Ayurvedic or nutraceutical supplement during the entire trial.
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of nonchildbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
排除标准
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •History of allergy or sensitivity to Curcumin, and related compounds or any component of the formulation.
- •History or presence of underlying inflammatory arthropathy, Rheumatoid arthritis (RA), severe OA, gout, Systemic Lupus Erythematosus (SLE) or any other systemic disorder affecting joints.
- •Subject with mild knee Osteoarthritis (Grade I and II) or severe knee Osteoarthritis (Grade IV) as per Kellgren Lawrence Scale.
- •Subject incapacitated or bound to a wheelchair or bed and unable to carry out selfcare activities.
- •Any indication of surgery for OA knee.
- •Subject with a previous history of any knee joint replacement surgery.
- •Recent injury in the area affected by OA of the knee (past 3 months).
- •Have taken any corticosteroid, indomethacin, Glucosamine chondroitin, within 3 months prior to the Treatment Period, Baseline (Visit 1) or intraarticular treatment or injections with corticosteroid or hyaluronic acid or Omega 3 Fatty acids dietary supplements within 6 months preceding the treatment period.
- •Known or clinically suspected infection with Human Immunodeficiency Virus (HIV), hepatitis B or C viruses.
- •Ayurvedic formulation or any form of Complimentary Alternative Medicine (CAM) therapy in the preceding 3 months.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
- •Subject with a history of uncontrolled diabetes.
- •The presence or history of Congestive Cardiac Failure.
- •Subject with poorly controlled hypertension (Systolic Blood Pressure greater than equal to 140 mm Hg and Diastolic Blood Pressure greater than equal to 90 mm Hg).
- •Subject who are taking calcium and vitamin D beyond Recommended Dietary Allowance (RDA) levels.
- •History or presence of psychiatric disorder that may impair the ability of Subjects to provide written informed consent.
- •History of high alcohol intake (greater than 2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening visit.
- •Any condition that in the opinion of the Investigator does not justify the Subjects inclusion in the study.
结局指标
主要结局
1. Mean Change from Baseline to End of Treatment in Knee injury and osteoarthritis outcome score (KOOS).
时间窗: Day 1, Day 14, and Day 28
2. Change in Endurance from Baseline to End of Treatment assessed by distance covered in 6 minutes walk test.
时间窗: Day 1, Day 14, and Day 28
次要结局
- Change from Baseline to End of Treatment in Joint Pain, as determined by Visual Analogue Scale (VAS) Score.(Day 1, Day 14, and Day 28)
- Changes from Baseline to End of Treatment in Complete Metabolic Panel (CMP) blood test and lipid profile.(Day 1, Day 14, and Day 28)
- Change from Baseline to End of Treatment in the requirement of analgesics as a rescue medication (Paracetamol).(Day 1, Day 14, and Day 28)
- Global tolerability assessment by patients and investigators at the end of the treatment on a 3 point scale ranging from good tolerability (side effects may be mild or not observed) to poor tolerability (side effects severe or warranting or needing discontinuation).(Day 1, Day 14, and Day 28)
- Proportion of patients reporting incidences of Adverse Events (AEs) and or Serious Adverse Events (SAEs) during the study.(Day 1, Day 14, and Day 28)
研究者
Mr Sachin Pawar
CLINICA Research Solutions LLP