NCT04117490已完成不适用
A Double Blind, Double Dummy, Dose Response, Randomized, Placebo Controlled Study to Assess the Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 8
- 主要终点
- Effect of consumption of IP on knee joint pain as assessed by the change in the 100-point Visual Analogue Scale (VAS) from baseline and when compared with the placebo.
研究概览
简要总结
Epiitalis is an ingredient of a currently marketed product named as Osteo-Restore, indicated for joint health.The present study is primarily planned to establish the role of Epiitalis as a single ingredient in the treatment of mild to moderate cases of knee Osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male & female aged ≥ 40 to ≤ 65 years suffering from primary idiopathic osteoarthritis of the knee diagnosed at least 3 months prior to screening.
- •2 BMI ≥ 18 and ≤ 29.9 kg/m
- •3 Fasting blood sugar ≤ 126 mg/dl 4 LFT: Serum Glutamic oxaloacetic transaminase (SGOT) & <2X Upper Limit of Normal (UNL) and Serum Glutamic-Pyruvic transaminase (SGPT) & <2X UNL.
- •5 Serum Creatinine & <1.5X UNL. 6 Index knee joint pain rated ≥ 60 on a 100-point Pain-Visual Analogue Scale (VAS).
- •Osteoarthritis grade II/ III (Kellgren-Lawrence classification) as confirmed by: Grade II - Definite osteophytes and possible joint space narrowing (JSN) on the anteroposterior weight-bearing radiograph Grade III - Multiple osteophytes, definite JSN, sclerosis, and possible bony deformity
- •Systolic blood pressure & <140 mmHg and diastolic blood pressure & < 90 mmHg
- •In the case of hypothyroidism, only euthyroid patients will be allowed to be screened further. Blood reports of last 3 months will be valid at the time of screening.
- •Female participants of childbearing age must be willing to use the accepted methods of contraception during the course of the study.
- •Participants should be willing to be involved in some
排除标准
- •History of osteoarthritis for more than 3 years.
- •History of osteoporosis and/or frequent fractures.
- •History of major trauma to the index joint.
- •History of arthroscopic surgery or intervention on the index joint or awaiting a replacement of knee or hip joint.
- •History of restless leg syndrome.
- •Participants who have received intra-articular steroids or hyaluronic acid within the last three months.
- •Not willing to abstain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health.
- •Not willing to abstain from application of local analgesics, herbal oil 48 hours prior to study visit.
- •Use of any immunosuppressive drugs in the last 12 months (including steroids).
- •Participants with deformity of the knee joint.
- •Participants categorized as ACR Functional Class I osteoarthritis
- •Participants who are significantly incapacitated or disabled and would be categorized as ACR Functional Class IV osteoarthritis (largely or wholly incapacitated), or unable to walk without assistive devices.
- •Participants with other known rheumatic or inflammatory diseases such as rheumatoid arthritis, osteomyelitis, and bone metastasis.
- •Current smokers or chronic alcoholics.
- •History of bleeding disorders.
- •Participants suffering from deep vein thrombosis.
- •Participants suffering from diabetic neuropathy.
- •History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
- •Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.
- •Participants having a history of any malignancy.
- •Inability to comply with the protocol requirements.
- •Participation in any other clinical trial within 3 months of registering in this trial.
- •. Women of child-bearing potential with a positive pregnancy test or who are lactating.
- •Any other condition which in the opinion of the Investigator may jeopardize the study.
研究组 & 干预措施
Epiitalis low dose
Active Comparator
Two capsules twice daily 30 mins before meals (breakfast & dinner).
干预措施: Epiitalis (Other)
Epiitalis mid dose
Active Comparator
Two capsules twice daily 30 mins before meals (breakfast & dinner).
干预措施: Epiitalis (Other)
Epiitalis high dose
Active Comparator
Two capsules twice daily 30 mins before meals (breakfast & dinner).
干预措施: Epiitalis (Other)
Placebo
Placebo Comparator
Two capsules twice daily 30 mins before meals (breakfast & dinner).
干预措施: Placebo (Other)
结局指标
主要结局
Effect of consumption of IP on knee joint pain as assessed by the change in the 100-point Visual Analogue Scale (VAS) from baseline and when compared with the placebo.
时间窗: From baseline to 56 days
Participant's assessment of pain will be done on a 100 mm Visual Analogue Scale (Pain), where 0 means no pain and 100 means unbearable pain.
次要结局
- Quality of life as assessed by a SF-36 questionnaire(From baseline to 56 days)
- Effect of IP consumption and the placebo on Knee joint pain, Knee joint stiffness & Knee joint function as assessed by a specific questionnaire(From baseline to 56 days)
研究者
研究点 (8)
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