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

NCT ID: NCT05853757

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2023-05-30

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.

Detailed Description

A sufficient number of adult subjects with an age group of 18 - 65 years old will be recruited/enrolled.

The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.

• Visit 01 (Day -07): Screening within 7 days from Day 01
• Visit 02 (Day 01): Enrolment Day
• Visit 03 (Day 15): End of treatment
• Visit 04 (Day 30): Telephonic follow-up Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) have to fill up the sleep diary before enrolment.

Assessment of safety and efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatment usage on Day 15 (+2 Days) as listed-below.

• Leeds Sleep Evaluation Questionnaire (LSEQ)
• Clinical examination - Scoring Based
• Sleep diary (sleeping time, the time interval in getting sleep, sleep interruptions, wake-up time, naps during the day, feeling, irritability, total duration of sleep, sleep quality.
• Product perception questionnaires (Product's effectiveness, likeliness and overall satisfaction- Hedonic scale (0-9-point scale)
• Blood parameter (CBC, ESR, RBS, SGOT, SGPT, S. Creatinine) - Safety Labs

Conditions

Difficulty in Sleep Initiation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Zzowin Nutra Tablet

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.

Group Type: EXPERIMENTAL

Zzowin Nutra Tablet

Intervention Type: DRUG

1 Tablet daily half an hour before going to bed

Interventions

Zzowin Nutra Tablet

1 Tablet daily half an hour before going to bed

Intervention Type: DRUG

Other Intervention Names

Herbal Supplement

Eligibility 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

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 dermatologist's/investigator'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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vedistry Private Limited

UNKNOWN

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Dr Nayan Patel

Principal Investigator-Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Nayan K Patel, MBBS

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, India

Countries

India

Other Identifiers

NB230006-VPL

Identifier Type: -

Identifier Source: org_study_id