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 acute inflammatory conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change in VAS score of pain
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 Acute Inflammatory Conditions incomparison with placebo ointment daily on three times daily dosage for 07 daysin 150 patients with chronic low back ache that will be conducted in fivecenters in India. The primary outcome measures will be Change in Visual AnalogueScale score of pain experienced at end of study as compared to baseline. The secondaryoutcomes will be Changein Pain relief score at end of study, Change in VAS score of pain experiencedduring normal activity in the preceding 24 hours at end of Day 3 as compared tobaseline, Total requirement of rescue analgesia and Patient’s and investigatorsoverall 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.Male or female outpatients aged 18 to 65 years 2.Patients with acute inflammatory condition (within 72 hours of entry in the study) like sprain, strain, or contusion 3.Patients with a pain score > 5 on visual analog scale (VAS) 4.Patients ready to give written informed consent and willing to comply the study protocol.
排除标准
- •1.Patients with an injury to the same body region within the prior 3 months or a lifetime history of 3 or more injuries to the injured body region 2.Use of NSAIDs (including acetaminophen) within 24 hours, opioids within 7 days, long acting NSAIDs like piroxicam or naproxem since the injury, any topical medication since injury or corticosteroid drugs by any route of administration within 60 days of entry in the study 3.Patients with an open lesion or serious injury, including a fracture, nerve injury, and a tear of ligament, muscle, or cartilage 4.Known hypersensitivity or intolerance or allergic type reactions to curcumin, boswellia or acetaminophen.
- •5.History of known alcohol, analgesic or narcotic abuse within 2 years.
- •6.Sensitive skin and loss of skin at the application site.
- •7.Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
- •8.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.
- •9.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
时间窗: experienced during normal activity in the preceding 24 hours at end of study as compared to baseline
次要结局
- Pain relief score(“spontaneous pain relief†and “pain relief during activity and movement†at the end of study)