A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.

NCT05853757 | Completed

• 1 other identifier: NB230006-VPL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A proof of science/concept clinical study with single-arm, single-blind, to evaluate safety, efficacy and in-use tolerability study of Herbal Supplement in adult human subjects having difficulty in falling asleep. A total of up to 32 subject will be enrolled to get 30 completed subject in the study.

Conditions

Difficulty in Sleep Initiation

Outcome Measures

Primary Outcomes (2)

• Change in quality of sleep

  To evaluate the effectiveness of test treatment in terms of change in quality of sleep by using Leed Sleep evaluation Questionnarie in which 0 indicate more difficult to 10 indicate Easier than usual

  From Baseline Day 01 (before usage) and Day 15 (post usage)

• Change in duration sleep

  To evaluate the effectiveness of test treatment in terms of change in duration of sleep by using Leed Sleep evaluation Questionnarie in which 0 indicate more difficult to 10 indicate easier than usual

  From Baseline Day 01 (before usage) and Day 15 (post usage)

Secondary Outcomes (10)

• Change in sleep quality by subjective self evaluated

  From Day -7 (before usage) and Day 15 (post usage)

• Improvement in overall health and wellbeing

  From Baseline Day 01 (before usage) and Day 15 (post usage)

• Subject product perception questionnaire

  Day 15 (post usage)

• Subject treatment perception

  Day 30 (post usage)

• Change in Complete Blood Count

  From Baseline Day 01 (before usage) and Day 15 (post usage)

Study Arms (1)

Zzowin Nutra Tablet

EXPERIMENTAL

Zzowin Nutra Tablet contains Melatonin, Tagar, L-theanine, L-Tryptophan, vitamin B6, Iron, Zinc, and Magnesium. which is helpful to provide deep, calm, and restful sleep.

Drug: Zzowin Nutra Tablet

Interventions

Zzowin Nutra Tablet DRUG

1 Tablet daily half an hour before going to bed

Also known as: Herbal Supplement

Zzowin Nutra Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years (both inclusive) at the time of consent.
• Sex: Healthy non-pregnant/non-lactating females and males.
• Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress.
• 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.
• Subject is generally in good health.
• 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.
• Habitual bedtime between 8.30 pm to midnight.
• Subject is willing to give written informed consent and are willing to follow the study procedure.
• Agree to comply with all study procedures

You may not qualify if:

• Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc.
• Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea.
• Subject who are substance dependence/ abuse in the past one year or with alcohol abuse.
• Subject who are using tobacco products during night awakenings.
• Subject with history of seizures or significant head trauma.
• 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.
• Subject Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
• 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.
• Any other investigational drug was used within three months prior the entry in this study.
• Subjects who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Vedistry Private Limited: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr. Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator-Medical Director

Model Details: Proof of science/concept, Single-arm, Single-blind

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 11, 2023
• Study Start: April 17, 2023
• Primary Completion: May 23, 2023
• Study Completion: May 30, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)