None listed
Conditions
Interventions
Intervention1: Melostacio Gold: Once Daily, With water, after dinner for 28 days
Control Intervention1: Placebo: Once Daily, with water, after dinner for 28 days.
Sponsors
Botanic Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a) Male and female adults aged between 18 and 54 years. b) Adult subjects who are willing to provide written informed consent to participate in the study. c) Free from psychiatric conditions, with the exception of mild stress. d) Capable of reading and writing in English.
Exclusion criteria
Exclusion criteria: a) Subjects with insomnia, sleep disorders, or chronic stress. b) Chronic alcoholics consuming more than 2 standard pegs per day. c) Subjects with known hypertension or other cardiovascular diseases. d) Subjects with a history of liver diseases, kidney diseases, psychiatric conditions, epilepsy, or any other relevant medical conditions. e) Subjects unwilling or unable to comply with the study protocol. f) Subjects currently participating in another clinical trial or who have received any investigational product (IP) within 90 days prior to Visit 1 (Screening). g) Subjects who withdraw their written informed consent at any point. h) Subjects currently taking medications other than oral contraceptives. i) Subjects on hepatotoxic medications, such as antitubercular medications, antiviral medications, or paracetamol. j) Pregnant women, those attempting to conceive, or lactating women. k) Individuals with acute narrow-angle glaucoma, prostate hypertrophy, or any cardiovascular, endocrine, renal, or other chronic diseases that could influence stress or anxiety or restrict normal daily functioning. l) Individuals with any diagnosable mental health disorder in the past 6 months (as assessed by the Mini International Neuropsychiatric Interview 6.0) or those currently taking psychotropic medications or other herbal preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in stress levels from baseline to the end of the studyTimepoint: Screening/Baseline,Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Cortisol levelsTimepoint: Baseline(Day 1) and Day 28;hs-CRP levelsTimepoint: Baseline(Day 1) and Day 28;Improvement in Quality of Life (QOL) using the SF-36Timepoint: Baseline(Day 1) and Day 28;Subject Global Assessment (SGA)Timepoint: Day 14 and Day 28;Physician Global Assessment (PGA) scoresTimepoint: Day 14 and Day 28;Change in weight and BMITimepoint: Screening/Baseline, Day 14, Day 28;Assessment of the safety of Melostacio Gold through hematological and biological evaluations, including ECG, Complete Blood Count (CBC), Liver Function Tests (LFT), Renal Function Tests (RFT), and Random Blood Sugar (RBS).Timepoint: Baseline (Day 1) and Day 28 | — |
Countries
India
Contacts
Public ContactT Sravani
Botanic Healthcare Pvt Ltd
Outcome results
None listed