None listed
Conditions
Interventions
None listed
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects aged between 40-70 years with a Body Mass Index â??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.
Exclusion criteria
Exclusion criteria: 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 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Nighttime pain (100mm VAS) Timepoint: Day 1, Day 7, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Consensus Sleep Diary â?? modified (CSD-M) completed daily upon waking Timepoint: Day 1, Day 7, Day 14 and Day 28;Change from baseline to the end of the study period in: Daytime pain assessment using Visual analog scale (100mm VAS) Timepoint: Day 1, Day 7, Day 14 and Day 28;Change from baseline to the end of the study period in: Inflammatory biomarkers (Hs-CRP and TNF-α)Timepoint: Day 1, Day 7 (Only hs-CRP) and Day 28;Change from baseline to the end of the study period in: Leeds Sleep Evaluation Questionnaire (LSEQ)Timepoint: Day 1, Day 7, Day 14 and Day 28 ;Change from baseline to the end of the study period in: Mood assessment (using POMS-SF scale)Timepoint: Day 1, Day 7, Day 14 and Day 28;Change from baseline to the end of the study period in: Restorative Sleep Questionnaire â?? weekly (RSQ-W)Timepoint: Screening, Day 1, Day 7, Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar
Laila Nutraceuticals
Outcome results
None listed