A Clinical Experiment Study for Wellness Capsule 500mg to Improve Overall Health and Wellbeing in Healthy Adult Human Subjects with having Difficulty to Fall Asleep
- Registration Number
- CTRI/2022/02/040362
- Lead Sponsor
- JSR Healthcare Private Limited Bare Body Essentials
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Age:� 18 to 65 years (both inclusive) at the time of consent.
2. Sex:� � Healthy males and non-pregnant/non-lactating females.
3. Females of childbearing potential must have a self-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 devices etc.
4. Subjects are generally in good health with a history of ANIDRA (Insomnia of short term) of less than three weeks.
5. Subjects who have > 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.
6. Habitual bedtime between 8.30 pm to midnight.
7. Body Mass Index between 19.5 to 30 kg/m2.
8. Subjects who are able to understand the sleep diary and are able to and willing to fill the sleep log diary and follow other procedures required by the study protocol.
9. Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (14% protein, 25% Fat and 61% carbohydrate).
10. Subject willing to participate in an exercise program (5 days a week, 45 mins walk per day)
11. Subjects willing to give written informed consent and willing to follow study procedure.
1. Subjects with known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological or neurological illnesses.
2. Subjects with a known history of hypersensitivity to Mangostana, Ashwagandha, Valeriana, Camellia Sinensis, Green Coffee, Garlic or any product containing the extract of these ayurvedic herbs/roots, leaves.
3. Subjects with the presence of any current psychiatric disorders that are judged by the Investigator as potentially causing or contributing to insomnia.
4. Subjects who suffer from sleep disorders other than primary insomnia including restless leg syndrome and sleep apnea.
5. Subjects who are substance dependent/abused in the past one year or with alcohol abuse.
6. Subjects who are using tobacco products during night awakenings.
7. Subjects with history of seizures or significant head trauma.
8. Subjects who worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
9. Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
10. Any other investigational drug was used within three months prior the entry in this study.
11. Subjects who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
12. 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 or immunosuppressive drugs within seven (7) days prior to first dosing.
13. Any other condition which could warrant exclusion from the study, as per the ayurvedic investigatorââ?¬•s/investigatorââ?¬•s discretion.
14. Pregnant or breastfeeding or planning to become pregnant during the study period.
15. Subjects participating in other similar nutraceuticals, dietary supplements, cosmetic, device or therapeutic trials within the last four weeks.
Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and will be documented in the case report form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.� To assess the effect of test treatment in terms of change in improvement in falling asleep from baseline visit i.e. Day 1 before dosing to Day 30 (4 weeks) post-treatment using sleep-rating questionnaires. <br/ ><br>2.� To assess the effect of test treatment in terms of change in improvement in overall health and wellbeing from baseline visit i.e. Day 1 before dosing to Day 30 (4 weeks) post-treatment using Ayurvedic clinical examinationTimepoint: 1.� To assess the effect of test treatment in terms of change in improvement in falling asleep from baseline visit i.e. Day 1 before dosing to Day 30 (4 weeks) post-treatment using sleep-rating questionnaires. <br/ ><br>2.� To assess the effect of test treatment in terms of change in improvement in overall health and wellbeing from baseline visit i.e. Day 1 before dosing to Day 30 (4 weeks) post-treatment using Ayurvedic clinical examination
- Secondary Outcome Measures
Name Time Method 1.� Mean % change in body weight from baseline on Day 01 before dosing to Day 30 post-dose. <br/ ><br>2.� To assess the effect of the test products in terms of change in lipid profile from baseline on Day 01 before dosing to Day 30 post-dose. <br/ ><br>3.� To assess the effect of the test treatment in terms of change in TSH from baseline on Day 01 before dosing to Day 30 post-dose. <br/ ><br>4. To assess the effect of test treatment in terms of product perception on Day 30 post-dose by the subjective perception about the product.Timepoint: Baseline on Day 01 before dosing and On Day 30 post-dose