CTRI/2014/07/004797暂停不适用
A Multicentric Randomized, Double Blind, Placebo Controlled Comparative Pilot Human Clinical Study to Assess the Efficacy and Tolerability of a Boswellia Serrata Extract Ointment in Patients with Chronic Low Back Ache
Clinfound Clinical Research Services PvtLtd4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年10月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Change in VAS score of pain experienced at end of study as compared to baseline.
研究概览
简要总结
Thisstudy is a randomized, double blind, parallel group, placebo controlledmulti-centre Pilot trial comparing the efficacy and Tolerability of a BoswelliaSerrata Extract Ointment in Patients with Chronic Low Back Ache in comparisonwith placebo ointment daily on three times daily dosage for 14 days in 140patients with chronic low back ache that will be conducted in five centers inIndia. The primary outcome measures will be Change in Visual Analogue Scalescore of pain experienced at end of study as compared to baseline. The secondary outcomeswill be Changein Modified Oswestry low back pain disability index score at end of study ascompared to baseline, Arthus Pain score (sum of current pain, average pain inlast week and worst pain in last week) at the end of study, Pain relief scoreat the end of study and Patient’s and investigators overall assessment.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with low back pain for at least 3 months and assessed on the Quebec Task Force system on Spinal Disorders as either •Class 1 (pain without radiation to an extremity and without neurological signs) or •Class 2 (pain with radiation to an extremity, but not below the knee and without neurological signs) 3.Patients with a pain score > 4 on visual analog scale (VAS) in the low back region at the time of randomization 4.Patients ready to give written informed consent and willing to comply the study protocol.
排除标准
- •1.Low back pain of Class 3 (pain with radiation distally beyond the knee and without neurologic signs) or Class 4 (Pain with radiation to the extremity and with neurologic signs) classified by the Quebec Task Force Classification for Spinal Disorders 2.Patients with specific causes of back pain (i.e. disc prolapse, spondylolisthesis, ischialgia, spinal stenosis), instability of the spine, spinal fractures, tumors, infections and inflammatory disorders, cervical spine syndrome or osteoporosis ,rheumatoid arthritis, Lyme’s arthritis, rheumatic factors >40 IU/L, seronegative spondyloarthropathies including ankylosing spondylitis, or neurologic etiology (i.e., radiculopathy, neuropathy, myelopathy) 3.Surgery for low back pain in the last 6 months or planning for surgical intervention during the course of the study.
- •4.Use of acetaminophen in last 12 hours; or any other systemic or topical analgesics, muscle relaxants in the last 7 days; and corticosteroids or nerve blocks in the past 4 weeks of randomization 5.Known hypersensitivity or intolerance or allergic type reactions to Boswellia or acetaminophen 6.History of known alcohol, analgesic or narcotic abuse within 2 years.
- •7.Sensitive skin and loss of skin at the application site.
- •8.Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
- •9.Presence of any severe medical or psychological condition or chronic condition /inflammation / infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study.
- •10.Participation in any other clinical study within 30 days of screening.
结局指标
主要结局
Change in VAS score of pain experienced at end of study as compared to baseline.
时间窗: Baseline, Day 7, Day 14
次要结局
- Change in Modified Oswestry low back pain disability index score at end of study as compared to baseline(Baseline, Day 7, Day 14)
- Pain relief score at the end of study(Baseline, Day 7, Day 14)
- Arthus Pain score (sum of current pain, average pain in last week and worst pain in last week) at the end of study(Baseline, Day 7, Day 14)
- Patients and investigators overall assessment(Baseline, Day 7, Day 14)
研究者
研究点 (4)
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