A randomized, double blind, placebo-controlled study to evaluate the analgesic effect of LI13108F among healthy subjects with Musculoskeletal pain.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from the baseline to end trial period in Pain intensity during eccentric movement (using VAS 100 mm scale)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of LI13108F in alleviating musculoskeletal pain.
A total of 120 (40 in each group) Male and female subjects aged between 25 and 45 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LI13108F - 100mg, LI13108F - 200mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast on day 3.
A part from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LI13108F will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Untrained, active, healthy, male and female ambulatory subjects (not involved in any kind of physical exercise protocols; involved in day-to-day regular activities) aged between 25 and 45 years with BMI of 20 to 29.9 kg/m
- •2.Willing to participate in a recommended eccentric exercise program of upper arm (elbow flexor) during specified visit.
- •3.Subjects who are not nutritionally deprived or malnourished as per Mini Nutritional Assessment (MNA-SF) score.
- •4.Subjects who are not receiving NSAID/analgesic therapy/ nutritional supplements for muscle pain.
- •5.Subjects who are non-smokers and non-alcohol user.
- •6.Female subjects of childbearing potential must be using a medically acceptable form of birth control e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit.
- •7.Subjects with clinical lab observations within normal range or considered not clinically significant by the principal investigator.
- •8.Subject willing to provide written informed consent and agree to be available for regular follow up throughout the study duration.
- •9.Willing to keep dietary records.
排除标准
- •1.History of OA or RA or any joint disorder.
- •2.Medical history of upper limb injury in the past six months.
- •3.History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
- •4.Subjects who are diabetic and/or hypertensive.
- •5.Subjects on nutritional supplement or herbal product since last one month.
- •6.Enrolment in another investigational study or intake of investigational drug within the previous three months.
- •7.Physical therapy treatment during the last 3 months 8.Any abnormal clinical laboratory test results or vital signs considered clinically significant in the opinion of the Investigator 9.Subjects with HIV Positive.
- •10.Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.) 11.Suspected or known allergy to any components of the study supplement.
- •12.Women who are pregnant, lactating or planning to become pregnant.
- •13.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
结局指标
主要结局
Change from the baseline to end trial period in Pain intensity during eccentric movement (using VAS 100 mm scale)
时间窗: (At Pre-dose and 1, 2, 3 & 5 hours post supplementation) on day 3.
次要结局
- Change from the baseline to end trial period in Pain pressure threshold (Pressure algometry) of biceps brachii at 5, 9, and 13 cm above the elbow crease((Pre-dose, 1, 2, 3, and 5 hours post dosing) on day 3)
- Change from the baseline to end trial period in Range of Motion (ROM)((Pre-dose, 1, 2, 3, and 5 hours post dosing) on day 3)
- Change from the baseline to end trial period in Use of Rescue medication.(Baseline to End of the study)