A Randomized Placebo Controlled double blinded Study to Assess the Efficacy of a Turmeric-Boswellia Blend in Adult Subjects with Acute Musculoskeletal Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. TOTPAR calculated as the weighted sum of the PRS scores
研究概览
简要总结
The potentialparticipants who are willing to provide a written informed consent form will beasked to come for screening (Day 1). The main inclusion criteria for thescreening procedure will be an NRS score of 5 or above. McGill –SFQ will alsobe taken at the screening which will be considered as the baseline score.
The participants willthen be randomized into either of the three groups on Day 1. The IPadministration is done on the same day after randomization. Post dose for every30 minutes interval up to 6h the participant will be asked to indicate theirresting pain intensity and pain relief, using the NRS and PRS scale.
The subject will takethe investigational product in the morning on day 2 and will score the painintensity and pain relief after 3h in the subject diary given.
On day 3 the subjectwill visit the site for end of the study follow up. The subject will consumethe product 3h before reaching the site. NRS and PRS will be measured.McGill-SF questionnaire will be taken at the site to evaluate quality of pain.
If there is need forrescue medication, then the subject will record pain intensity before takingrescue medication and the consumption recorded.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult subject, Male or female between 18-65 years of age.
- •2.A score of 5cm or above on the NRS 3.Subjects having acute musculoskeletal pain which occurred within 24 hours before presentation.
- •(musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 sprain or strain), not requiring admittance to hospital.) 4.Willing to give voluntary informed consent.
排除标准
- •1.Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles.
- •Subjects with Grade 2 & 3 sprain or strain or muscle cramps due to dehydration.
- •2.Subjects with known history of osteoarthritis and rheumatoid arthritis.
- •3.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
- •4.Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
- •5.Subjects underlying dermatitis or dermatosis associated with the injury.
- •6.Use of any oral or topical analgesic, antipyretic, sedative or anti-inflammatory treatment, Use of any topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetic products at the site of pain within 1 week prior to study or during the study.
- •7.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation.
- •8.Any kind of neuralgic pain, headache and/or chronic pain 9.Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
- •10.A known pregnancy or lactation 11.Previous history of gastro-intestinal haemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding.
- •12.Subjects who are severe smokers and drinkers 13.Received an investigational product or participated in an investigational study within a period of 30 days prior to receiving study medication.
- •14.Scheduled elective surgery or other invasive procedures during the period of study participation.
- •15.Subjects had a history of diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV, HIV).
- •16.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.
结局指标
主要结局
1. TOTPAR calculated as the weighted sum of the PRS scores
时间窗: 1. Pain relief score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr. | 2. Pain intensity score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr.
2. SPID calculated as the weighted sum of the NRS scores
时间窗: 1. Pain relief score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr. | 2. Pain intensity score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr.
次要结局
- Earliest onset of pain relief(From post-dose to censored at 6hrs)
- McGill Short Form Questionnaire(Screening, Day 3 post dose)
- Change in Reduction of pain intensity(Baseline, Day 3)
- Change in Pain relief(Baseline, Day 3)