A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9619CP Turmeric extractin Joint Health
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To study the efficacy of turmeric in subjects with mild to moderate knee Osteoarthritis
研究概览
简要总结
Osteoarthritis is acommon, chronic, progressive, skeletal, degenerative disorder, which commonlyaffects the knee joint. Degenerative joint disease is the most common jointpathology and the main cause of disability of elderly people in developedcountries.OA is characterized by articular cartilage degradation with anaccompanying periarticularbone response. OA of the knee and hip are a growing healthconcern and are the most common form of arthritis Pain and disease can range from very mild to very severe. Patients with OA havepain that typically worsens with weight bearing, including walking and standing,and improves with rest Due to decreased movement because of the pain, regional muscles mayatrophy, and ligaments may become more lax. Other side effects include morningstiffness and gelling of the involved joint after periods of inactivity. Severeinflammation is not a prevalent sign ofOA, but inflammation due to the boneoutgrowths, does occur .The progressionof OA is aslow process taking years. Treatment of OA may include exercise,heat/cold therapy, joint protection,weight loss, physiotherapy/occupational therapy and medications . The most commonmedications include acetaminophen and NSAIDs.
The purpose of this study isto evaluate the efficacy and tolerability of BHC9619CP Turmericextract in Joint Health
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ambulatory, male and female subjects of 40–70 years of age with a Body Mass Index (BMI) of 20 to 29 kg/m
- •2.Subjects with VAS score between 40 and 70 mm.
- •3.Subjects with Knee osteoarthritis grade II to III of Kellgren and Lawrence assessed based on X-ray.
- •4.Willing to refrain from use of glucosamine, chondroitin, MSM, 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 ready to discontinue the use of supplementations including vitamins, glucosamine + chondroitin, herbals or other topical applications.
- •8.Agree to participate in the study through a written informed consent.
- •9.Willing to comply with all the study related activities.
排除标准
- •1.Previous injury and or surgery to the knee.
- •2.Expectation of surgery during the study period.
- •3.Subjects with uncontrolled Diabetes 4.Subjects suffering from COPD or having history of any respiratory or breathing disorders.
- •5.Subjects used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
- •6.Female subjects who are pregnant breast feeding or planning to become pregnantduring the study period.
- •7.Subjects having known allergy to non steroidal antiinflammatory drugs NSAIDs including aspirin or has a suspected hypersensitivity allergy or sensitivity to herbal products.
- •8.Have taken any corticosteroid indomethacin within 1 month prior to theenrollment or intra articular treatment injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
- •9.History of congestive heart failure or any vascular conditions.
- •10.Subjects with HIV Positive status.
- •11.Evidence or history of clinically significant in the judgment of the Investigator hematological renal, endocrine pulmonary gastrointestinal cardiovascular hepatic neurologic diseases or malignancies hypothyroidism.
- •12.History of Systemic Lupus Erythematous 13.Alcohol intake greater than 2 standard drinks per day or use of recreational drugs such as cocaine methamphetamine, marijuana, etc 14.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •15.Participation in any other trials involving investigational or marketed products within 30days prior to the screening visit.
- •16.Have taken acetaminophen paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any herbal products within 7 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.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
To study the efficacy of turmeric in subjects with mild to moderate knee Osteoarthritis
时间窗: Day 0, Day 28 and Day 56
次要结局
- To study the safety and tolerability of the study supplement by monitoring the vital signs and possibility of adverse events at each follow-up.(Day 0 and Day 56)