Clinical Study to evaluate the Safety and Efficacy of KaraCalmTM - to manage stress and improve sleep in adults

Active, not recruiting

Conditions: Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: NIDRANASAH/ASVAPNAH, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: OJAKSHAYAH,

Brief Summary: Thisis a randomized, placebo controlled double blind clinical study to evaluate theSafety and efficacy of a dietary supplement (KaraCalm) - to manage Stress andimprove Sleep in adults. Allsubjects will receive either Test or Reference product for a period of 56 days.The efficacy parameters will be analyzed on Baseline, Day 14, Day 28 and Day 56.

Recruitment & Eligibility

Inclusion Criteria

1.Male and Female healthy adult subjects ranging in age from 18 to 54 years.
2.Adults Subjects willing to provide a written Informed Consent 3.Free of psychiatric conditions other than mild stress 4.Could read and write English.

Exclusion Criteria

1.Subjects with insomnia, sleep disorders, or chronic stress 2.Chronic alcoholics (more than 2 standard pegs / day) 3.Subjects with known Hypertension and other diseases of the cardiovascular system 4.Subjects with known Liver diseases, Kidney diseases, Psychiatric diseases, Epilepsy and/or with any other relevant diseases 5.Subjects with the intention of non-compliance to the study-protocol 6.Subject participating in another clinical trial or has received any IP within 90 days prior to Visit 1 (Screening).
7.Retraction of the written informed consent 8.Subjects currently taking medications other than oral contraceptive pill 9.Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
10.Pregnant, attempting to conceive, or lactating women 11.Individuals with acute narrow-angle glaucoma, prostate hypertrophy, cardiovascular, endocrine or renal disease, or another chronic disease that could affect stress/anxiety or restrict normal, daily function were also ineligible to participate in the study.
12.Individuals who currently, or in the past 6 months, suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 6.0) or were taking a psychotropic medication or other herbal preparation were also excluded from participating in the study.

Primary Outcome Measures

Name	Time	Method
Change from baseline - Sleep analysis by using Acti Watch	Baseline, Day 14 and Day 56

Secondary Outcome Measures

Name	Time	Method
To assess the Safety and Tolerability of IP	Baseline and Day 56
Change from baseline to the end of the study in Perceived Stress Scale	Screening, Baseline, Day 14, 28, & 56
Change from baseline to the end of the study in Athens Insomnia Scale	Screening, Baseline, Day 14, 28, & 56
Change from baseline to the end of the study in Serum Cortisol	Baseline, Day 14 and Day 56
Change from baseline to the end of the study in Hs CRP	Baseline, Day 14 and Day 56

Locations (1): Vatsalya Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Vatsalya Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Ashish Kumar Gupta
Principal investigator
9415227170
Ashishkgmcbhu07@gmail.com