A randomized, double blind, placebo controlled clinical study to assess the efficacy of LN22197 in healthy subjects with sleep disturbance due to mild to moderate musculoskeletal discomfort.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline to the end of the study period in:
研究概览
简要总结
The purpose of this study is to assess the efficacy of LN22197 in healthy subjects with sleep disturbance due to mild to moderate musculoskeletal discomfort. A total of 60 male and female subjects of age between 40 and 70 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 one of the two study groups (LN22197 300 mg or Placebo) at 1:1 ratio. The participants will be instructed to take one capsule daily after dinner for 28 days. The outcome measures include Nighttime pain (100mm VAS), Daytime pain assessment using Visual analog scale (100mm VAS), Restorative Sleep Questionnaire–weekly (RSQ-W), Leeds Sleep Evaluation Questionnaire (LSEQ), Mood assessment (using POMS-SF scale), Consensus Sleep Diary – modified (CSD-M) completed daily upon waking and Inflammatory biomarkers (Hs-CRP and TNF-α). Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of LN22197 will also include the 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 and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects aged between 40-70 years with a Body Mass Index –BMI of 20 to 29 kg per metre square.
- •2.Subjects with self-reported disturbed sleep due to musculoskeletal discomfort, and scoring less than or equal to 60 on Restorative Sleep Questionnaire-RSQ-W.
- •3.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
- •4.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •5.Subjects agree to discontinue or not use supplements including vitamins and minerals, herbals or any other topical applications at least 15 days before screening visit, and for the duration of the study.
- •6.Subject agrees to complete the Consensus Sleep Diary daily upon waking.
- •7.Subjects agree to participate in the study through a written informed consent.
- •8.Subject willing to refrain from caffeine consumption in the 5 hour before their regular bedtime.
- •9.Subject agrees to not wear or use any sleep tracking devices i.e. FitBit, Garmin, Oura, Apple or Android smart watches or apps for the duration of the study.
- •10.Subject agrees to not take acetaminophen/paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever-OTC or prescription- or any herbal products for the duration of the study.
- •11.Subjects willing to comply with all the study related assessments and activities.
- •12.Willing to maintain current diet and activity level.
排除标准
- •1.Subjects having post COVID symptoms or underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •2.Subjects suffering from severe intrinsic sleep-related disorders such as sleep apnea, restless leg syndrome -RLS, narcolepsy.
- •3.Subjects having taken any sleep medication in the prior 6 months.
- •4.Subjects suffering from COPD or having history of any respiratory or breathing disorders.
- •5.Subjects who are diabetic-FBG greater than or equal to 126 mg per dl and or hypertensive-BP- Systolic greater than 145 mmHg and Diastolic greater 90 mmHg or need to take drug for diabetes or hypertension as per PIs opinion.
- •6.Subjects with any musculoskeletal injury in the last 3 months or surgery in prior 6 months.
- •7.Subjects used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
- •8.Subjects with diagnosed osteoarthritis, rheumatoid arthritis or fibromyalgia.
- •9.Female subjects, who are pregnant, breastfeeding or planning to become pregnant during the study period.
- •10.Subjects with known allergy to non-steroidal anti-inflammatory drugs-NSAIDs including aspirin or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
- •11.Subjects with history of congestive heart failure or any vascular conditions.
- •12.Subjects with HIV Positive status.
- •13.Evidence or history of clinically significant-in the judgment of the Investigator hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- •14.Alcohol intake greater than two standard drinks per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc.
- •15.Subjects currently suffering from depression or anxiety.
- •16.Subjects with any lifestyle factors that might be potentially associated with sleep problems such as excessive caffeine intake, shift work, and long distance traveling, or significant stressors, such as active grieving.
- •17.Subjects who regularly consume more than three cups of coffee or the equivalent in energy drinks.
- •18.Subjects with history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •19.Participation in any other trials involving investigational or marketed products within thirty days prior to the screening visit.
- •20.Have taken acetaminophen or paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever-OTC or prescription or any herbal products within seven days prior to the screening visit -visit
- •21.History of heart, liver, lung cancer or chronic diseases.
- •22.Subjects allergic to any ingredient of the study investigational products.
- •23.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
结局指标
主要结局
Change from baseline to the end of the study period in:
时间窗: Day 1, Day 7, Day 14 and Day 28
Nighttime pain (100mm VAS)
时间窗: Day 1, Day 7, Day 14 and Day 28
次要结局
- Change from baseline to the end of the study period in:(Inflammatory biomarkers (Hs-CRP and TNF-α))
- Change from baseline to the end of the study period in:(Mood assessment (using POMS-SF scale))