None listed
Conditions
Interventions
Intervention1: Zzowin Nutra Tablet: Mode of Usage: 1 Tablet daily half an hour before going to bed
Route of Administration: Oral Administration with adequate amount of water.
Control Intervention1:
Sponsors
Vedistry Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 years (both inclusive) at the time of consent. 2) Sex: Healthy non-pregnant/non-lactating females and males. 3) Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress. 4) Female of childbearing potential must a reported negative pregnancy test, agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc. 5) Subject is generally in good health. 6) Subjects who having > 30 minutes to fall asleep and subjective total sleep time of is 6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep. 7) Habitual bedtime between 8.30 pm to midnight. 8) Subject is willing to give written informed consent and are willing to follow the study procedure. 9) Agree to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1) Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc. 2) Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea. 3) Subject who are substance dependence/ abuse in the past one year or with alcohol abuse. 4) Subject who are using tobacco products during night awakenings. 5) Subject with history of seizures or significant head trauma. 6) Subject worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period. 7) Subject Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis). 8) Use of any: (i) Prescribed or over-the-counter (OTC) anti-inflammatory or medicine that leads to overweight like corticosteroids drugs within five (5) days prior to dosing. (ii) Antihistamine medication/immunosuppressive drugs within seven (7) days before first dosing. 9) Any other investigational drug was used within three months prior the entry in this study. 10) Subjects who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent 11) Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion. 12) Pregnant or breastfeeding or planning to become pregnant during the study period. 13) Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate the Effectiveness of Test Treatment in terms of Change in Quality of Sleep and Duration of Sleep.Timepoint: Before Test Treatment Usage at Day 01 and After test Treatment Usage at Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate the Effectiveness of Test Treatment in terms Dependence and withdrawal symptoms by treatment perception questionnaire by hedonic scaleTimepoint: After Test Treatment Usage at Day 30;To assess the effect of Test Treatment in terms of Change in Sleep Quality by Subjective Self-EvaluationTimepoint: Before Test Treatment usage at Day -7 and After Test Treatment Usage at Day 15;To assess the Effect of Test Treatment in terms of difference in Blood Biochemical ParameterTimepoint: Before Test Treatment Usage at Day 01 and After Test Treatment Usage at Day 15;To Assess the Effect of Test Treatment in terms of Improvement in overall health by clinical examination Timepoint: Before Test Treatment Usage at Day 01 and After Test Treatment Usage at Day 15;To Assess the Effect of Test Treatment in terms of product perception questionnaire by hedonic ScaleTimepoint: After Test Treatment Usage at Day 15 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed