None listed
Conditions
Interventions
Intervention1: BlaQmax: Oral administration of single BlaQmax capsule for 14 days
Control Intervention1: Placebo: Oral administration of single Placebo capsule for 14 days
Sponsors
Akay Natural Ingredients Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. RSQ-W total score less than 50 2.Have not taken any hypnotic medicine since last one month 3. Can read and write English. 4.No history of psychiatric conditions 5.Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages. 6.Should be willing to adhere with their routine diet and exercise regimen throughout the study. 7.Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of Consumed Melatonin or any other sleep enhancing nutritional supplements within last 6 months ,Ischemic heart disease, valvular heart disease, pacemakers, Severe intrinsic sleep related disorders such as severe sleep apnoea, Respiratory disorders Seizure disorders Mental disorders, clinical anxiety, depression, Cushingâ??s syndrome and other major ailments, History of renal or liver impairment, Allergic to herbal products 2. Subjects on medication/dietary supplements that may affect the measured responses, including medicines for anxiety, depression; prednisone, dexamethasone and other steroids administered orally or intravenous 3. History of drug addiction or alcohol abuse (regularly consumes more than 2 alcoholic drinks per day), smokers of more than 10 cigarettes/day. 4. Women who are pregnant or nursing. 5. If the subjects required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including anxiolytics, central nervous system active drugs, hypnotics, narcotic analgesics, anti-inflammatory agents, antidepressants, proton pump inhibitors, antacids, beta blockers, anticonvulsants, St Johns Wort, sedating H1 antihistamines, Kava-kava, systemic steroids, Ginkgo biloba, respiratory stimulants, over the counter and prescriptions stimulants, decongestants, over-the-counter and prescription diet aids, antipsychotics, melatonin, drugs for oral alkalinisation and all other drugs or supplements known to affect sleep or wake 6. Patients with any other serious concurrent illness or malignancy. 7. Subjects on hormonal birth-control measures 8. Subjects allergic to herbal products, nuts or any component of the study product 9. Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study 10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sleep assessment parametersTimepoint: Day 0, Day 8, Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in BiomarkersTimepoint: Day 0, Day 15;Changes in Questionnaire based AsessmentsTimepoint: Day 0, Day 8, Day 15 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed