A clinical study to assess the safety and effectiveness of Herbal Supplement in adult human subjects.
- Registration Number
- CTRI/2023/04/051587
- Lead Sponsor
- Vedistry Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method