The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout/withdrawal rate of 25%. The intervention duration for all the study participants is 180 days.
Male & female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg/m2 (inclusive)
Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.
Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data.
Males who has a history of oligospermia, vasectomy and other sperm abnormalities.
Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.
Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.