A Randomized Double-Blind Placebo Controlled Trial to Determine the Status of Post Knee Chondroplasty Patients Administered Theramine Versus Placebo in Addition to Post Surgery Analgesics
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Dose reduction of analgesic.
研究概览
简要总结
The purpose of this study will be to show the patient response to analgesics taken post surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The data collected will be used to show that patients have a shorter and lower post operative pain measurement and the time to discontinuation of analgesics is less in the active comparator group.
详细描述
No other decription
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed knee pain requiring chondroplasty knee arthroscopic surgery.
- •Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read, understand and sign English-language informed consent.
- •If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-consultants), treatment must be stable for at least three (3) months prior to study.
- •For men and women of child-bearing potential, must be willing to use adequate contraception and not be pregnant or impregnate their partner during the entire time of study.
- •Must be willing to commit to all clinical visits during study-related procedures.
- •Require use of narcotics for pain relief.
排除标准
- •Patients with significant neurologic impairment, as diagnosed on screening physical examination.
- •Patients not fluent in English.
- •Patients currently involved in a Workman's Compensation case related to this procedure.
- •Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening.
- •History of substance abuse.
- •History of malignancy, other than basal or squamous cell of the skin within the last 5 years.
- •Tibial plateau fracture within 6 months prior to surgery.
研究组 & 干预措施
Theramine
Theramine 2 capsules three times per day in addition to post surgical analgesic medication.
干预措施: Theramine (Drug)
Theramine-like Placebo
Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication.
干预措施: Theramine- like placebo (Drug)
结局指标
主要结局
Dose reduction of analgesic.
时间窗: 28 days
The primary efficacy outcome will be the overall dose reduction of analgesic in the Theramine active group versus the Theramine placebo group.
次要结局
- Change in second Knee pain scale.(28 Days)
- Change in Visual Analogue Scale Evaluation (VASE)(28 days)
- Time to discontinuation of analgesic.(28 days)