A randomized, double blind, placebo controlled comparative study to assess the efficacy and safety of Gogo Pain Relief & MSM (M) oil in treatment of osteoarthritis (OA) of the knee
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 3.Range of motion in degrees. X-ray will be done both at baseline and at the end of the treatment to evaluate the benefit of the treatment.
研究概览
简要总结
The studywill enrol adults aged between 35-65 years that have diagnosed with OA based onradiographic evidence. Eligibleparticipants screened in baseline interview will be randomized into two groupsto be treated with either the test product Gogo Pain Relief & MSM (M) or comparator. The baseline interview will collectsociodemographic data pain level in the last week using the Visual Analog Scale(VAS) (0= no pain; 10= worst pain ever), and functionality in activities ofdaily living with the Western Ontario and McMaster Universities OsteoarthritisIndex (WOMAC). An X-ray of the affected area will be done for the baselineassessment and at the end of treatment to evaluate the efficacy of thetreatment. In addition to the test product/ placebo, a standard treatmentprescribed by a physician will be given to the patients with osteoarthritis.
Subjectswill be evaluated at the end of first (Day 30), second (Day 60) and third month(Day 90) (assessment visits) regarding pain and functional state, subsequent tothe initiation of treatment. Safety analyses will be done at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants must be adults, aged at least 35 to 80 yrs old with radiographically established OA.
- •2.At screening, subjects must complete questionnaires that would provide investigators with information on their medical and OA history and demographics.
- •Pain level in the last week will be evaluated using the Visual Analog Scale (VAS) and functionality in activities of daily living with the Western Ontario and McMaster Universities Osteoarthritis Index.
- •3.Females Subjects must have a negative pregnancy test.
- •Pregnant patients or individual with history of pregnancy will be excluded from the study.
- •4.Subjects should be having a pre-randomization score of 40 to 90 on the Western Ontario and McMaster Universities Osteoarthritis Index.
- •5.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
- •6.Participants must be willing to apply the test product and return for assessment visits for evaluation.
- •7.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications that has not been recommended by the study physician.
排除标准
- •1.Participants with rheumatoid arthritis; fibromyalgia; recurrent or active pseudogout, cancer, or other serious medical conditions 2.Single or married subjects who are pregnant or have borne children in past one year.
- •3.Participants with a history of signs or history of kidney or liver failure OR asthma requiring use of corticosteroids OR use of oral corticosteroids within the past 4 weeks 4.Participants with a history of intra-articular knee depo corticosteroids within the previous 3 months, or intra-articular hyaluronate within the previous 6 months.
- •5.Participants with evidence or history of medical or surgical event in the past year that may significantly affect the study outcome such as arthroscopy of the knee within the previous year; significant injury to the knee within the previous 6 months; or a rash or open wound over the knee.
- •6Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician.
- •7.Participant with known allergies to the main components of the test product or placebo.
- •8.Participation in another clinical trial or taking an investigational product in the past three months 9.Any participant who is not able to give informed consent.
结局指标
主要结局
3.Range of motion in degrees. X-ray will be done both at baseline and at the end of the treatment to evaluate the benefit of the treatment.
时间窗: Day 0 | Day 30 | Day 60 | Day 90
1.A negative change in WOMAC scores from baseline indicating improvement of symptoms and limitations; as compared to the placebo (WOMAC assesses pain, stiffness and physical functional disability using a series of 24 questions).
时间窗: Day 0 | Day 30 | Day 60 | Day 90
Primary Criteria for efficacy are:
时间窗: Day 0 | Day 30 | Day 60 | Day 90
2.Negative change in the VAS score assessing pain
时间窗: Day 0 | Day 30 | Day 60 | Day 90
次要结局
- The secondary endpoints comprise of the safety analyses i.e Adverse events including SAEs.(Day 0)