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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
200
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
0.5 ml sublingually to be consumed after dinner, 30 min ± 5 mins before going to bed.
Shivam Hospital
Dombivali, Maharashtra, India
RECRUITINGDhanwantri Hospital
Pune, Maharashtra, India
RECRUITINGVedant Multispeciality Hospital
Pune, Maharashtra, India
RECRUITINGPunawale Hospital
Pune, Maharashtra, India
RECRUITINGVishwaraj Hospital
Pune, Maharashtra, India
RECRUITINGShree Ashirwad Hospital
Thane, Maharashtra, India
RECRUITINGTo evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Fasting Glucose normal range is 74 - 106 mg/dL
Time frame: Day -5 to Day -1
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Fasting Glucose normal range is 74 - 106 mg/dL
Time frame: Day 90
To evaluate the safety of VL-SE-01 by assessing Fasting Blood Glucose as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Fasting Glucose normal range is 74 - 106 mg/dL
Time frame: Day 180
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
Time frame: Day -5 to Day -1
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Glomerular Filtration Rate (GFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL GFR: Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
Time frame: Day 90
To evaluate the safety of VL-SE-01 by assessing Renal function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Renal function tests measure the efficiency of kidneys and include Electrolytes (Sodium, Potassium, and Chloride), Creatinine, Estimated Glomerular Filtration Rate (eGFR), Blood Urea Nitrogen, Blood Urea and Calcium tests. Normal range for these tests are mentioned below: Sodium:136 - 145 mmol/L Potassium: 3.5 - 5.1 mmol/L Chloride: 98 - 107 mmol/L Creatinine: Males - 0.7 - 1.2 mg/dL; Females - 0.5 - 0.9 mg/dL eGFR: 60 - 200 mL/min/1.73 m² Blood Urea Nitrogen: Males - 18 yrs - 49 yrs : 8.87-22.88 mg/dL, \> 50 yrs : 9.80-22.88 mg/dL; Females - 18 yrs - 49 yrs : 7.47-17.74 mg/dL, \> 50 yrs : 8.87-21.94 mg/dL Blood Urea: Males - 18 yrs - 49 yrs : 19 - 49 mg/dL, \> 50 yrs : 21 - 49 mg/dL; Females - 18 yrs - 49 yrs : 16 - 38 mg/dL, \> 50 yrs : 19 - 47 mg/dL Calcium: 8.6 - 10.0 mg/dL
Time frame: Day 180
To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L
Time frame: Day -5 to -1
To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L
Time frame: Day 90
To evaluate the safety of VL-SE-01 by assessing Liver function as part of the Complete Metabolic Panel (CMP) before and after IP consumption.
Liver Function tests help determine the health of liver by measuring the levels of Albumin, Total Proteins, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Bilirubin, and gamma-glutamyl transferase (GGT) levels in blood. Albumin: 3.5 - 5.2 g/dL Total Proteins: 6.6 - 8.9 g/dL Alkaline Phosphatase: Males - 40 - 129 U/L; Females - 35 - 104 U/L ALT: Males - Up to 41 U/L; Females - Up to 33 U/L AST: Males - Up to 40 U/L; Females - Up to 32 U/L Bilirubin: Total Bilirubin - Up to 1.2 mg/dL; Direct Bilirubin - Up to 0.3 mg/dL; Indirect Bilirubin - Up to 0.9 mg/dL GGT: Males - 10 - 71 U/L; Females - 6 - 42 U/L
Time frame: Day 180
To assess the safety and tolerability of VL-SE-01 using blood, which includes Complete Blood Count (CBC).
CBC measures red blood cells (RBC) which basically carries oxygen, white blood cells (WBC)(Leukocytes), which fights with infection, hemoglobin (Hb), which carries oxygen protein in blood cells, and platelets, which help blood to clot. A complete blood count can show unusual increases or decreases in cell counts. Normal ranges for the parameters are as follows: Hb: Males: 13 - 17 g/dL; Females - 11.5 - 15.2 g/dL Total RBC: Males - 4.2 - 6.0 million cells/cumm; Females - 3.8 - 5.2 million cells/cumm Total WBC: 3500 - 10000 / cumm Platelet Count: 150000 - 400000 / cumm
Time frame: Day -5 to Day -1, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 using blood, which includes Inflammation by analyzing CRP levels.
Normal reference range: 0 -5.0 mg/L
Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 using blood, which includes Hormonal profile (Luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, estradiol and progesterone)
Leutinizing Hormone in Females reference range: Follicular Phase : 2.4 - 12.6 mIU/mL Ovulating Phase : 14.0 - 95.6 mIU/mL Luteal Phase : 1.0 - 11.4 mIU/mL Post menopausal : 7.7 - 58.5 mIU/mL Follicular Stimulating Hormones in Females reference range: Follicular Phase : 3.5 - 12.5 mIU/mL Ovulating Phase : 4.7 - 21.5 mIU/mL Luteal Phase : 1.7 - 7.7 mIU/mL Post menopausal : 25.8 - 134.8 mIU/mL Progesterone in Females reference ranges: Follicular phase: 0.2 - 1.5 ng/ml Ovulatory phase: 0.8 - 3.0 ng/ml Luteal phase: 1.7 - 27.0 ng/ml Post menopause: 0.1 - 0.8 ng/ml Estradiol in females reference range: Follicular phase :12.5-166 pg/ml Ovulatory phase :85.5-498 pg/ml Luteal phase : 43.8-211 pg/ml Post menopause : 5.0-54.7 pg/ml Pregnancy,1st trimester: 215-4300 pg/ml Testosterone in Males reference range: 2.8 - 8.0 ng/mL
Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 using blood, which includes Thyroid profile (T3, T4, TSH)
Total Triiodothyronine (T3) reference range: 1.3 - 3.1 nmol/L Total Thyroxine (T4) reference range: 5.1 - 14.1 μg/dL Thyroid Stimulating Hormone (TSH) reference range: 0.27 - 4.2 μIU/mL
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Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 using blood, which includes Lipid Profile as assessed by levels of total cholesterol, LDL, HDL and triglycerides
Total Cholesterol: Desirable: \< 200 mg/dL, Borderline High : 200 - 239 mg/dL, High : ≥ 240 mg/dL Triglyceride: Normal : \< 150 mg/dL, Borderline : 151 - 199 mg/dL, High : 200 - 499 mg/dL, Very High : \> 500 mg/dL HDL Cholesterol: 40 - 60 mg/dL LDL Cholesterol: Optimal : \< 100 mg/dL, Near / Above Optimal : 101-129 mg/dL, Borderline High : 130 - 159 mg/dL, High : 160 -189 mg/dL, Very High : \> 190 mg/dL
Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 on Semen.
Assessment of semen will be done using the following parameters: Physical examination which includes factors like Volume (\>1.5 ml), appearance, Colour, Viscosity (\<2 cm thread after liquefaction) and pH (\>= 7.2) of the sample. Microscopic Examination which includes Sperm count \[Sperm concentration is the number of sperm per milliliter of semen (Reference Range: \>=16 Million/ml)\] and Motility \[Sperm motility is the ability of your sperm to swim (\>=42 %)\]
Time frame: Day -5 to Day -1 and Day 180
To assess the safety and tolerability of VL-SE-01 using blood Plasma levels of CBD and its metabolites [7-Carboxy-cannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7-OH-CBD)]
(will be conducted in 15 participants only in each group except placebo)
Time frame: Day 195 (single timepoint)
To assess the safety and tolerability of VL-SE-01 on Blood Pressure.
Vitals signs measures basic functions of the body. In this case, Blood pressure (BP) will be measured. Blood pressure will be measured using a calibrated digital monitor. Systolic BP (measured in mmHg): Optimal - \<120, Normal - 120 - 129, High normal - 130 - 139, Grade 1 hypertension - 140 - 159, Grade 2 hypertension - 160 - 179, Grade 3 hypertension - ≥180, Isolated systolic hypertension - ≥140. Diastolic BP (measured in mmHg): Optimal - \<80, Normal - 80 - 84, High normal - 85 - 89, Grade 1 hypertension - 90 - 99, Grade 2 hypertension - 100 - 109, Grade 3 hypertension - ≥110, Isolated systolic hypertension - \< 90.
Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 on Pulse Rate.
Vitals signs measures basic functions of the body. In this case Heart rate \[also known as Pulse rate (PR)\] will be measured. Pulse rate will be measured by palpatory method by counting the number of beats in 30 seconds. Normal Pulse rate: 60 - 100 beats per minute (bpm) Bradycardia: \< 60 bpm Tachycardia: \> 100 bpm
Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 using Electrocardiogram.
The electrocardiograph is a device that picks up electrical activity originating in the heart from the surface of the body for clinical diagnosis of cardiac function. The following parameters will be considered for the study: The QT interval is the time from the beginning of the QRS complex, representing ventricular depolarization, to the end of the T wave, resulting from ventricular repolarization. In general, the normal QT interval is below 400 to 440 milliseconds (ms), or 0.4 to 0.44 seconds. Women have a longer QT interval than men. The corrected QT interval (QTc) estimates the QT interval at a standard heart rate of 60 bpm. Normal values for the QTc range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women; however, 10%-20% of otherwise healthy persons may have QTc values outside this range. The PR interval is the time from the beginning of the P wave (atrial depolarization) to the beginning of the QRS complex (ventricular depolarization). The normal
Time frame: Day 0, Day 90, Day 180 and Day 195
To assess the safety and tolerability of VL-SE-01 using Treatment emergent Adverse Events (TEAEs).
The number and percent of research participants reporting AEs will be tabulated by intervention group and will be compared between the groups.
Time frame: Day 0, Day 90, Day 180 and Day 195
To evaluate the efficacy of VL-SE-01 on the basis of Incidence of gastrointestinal dysfunction using Structured Assessment of Gastrointestinal Symptoms (SAGIS) questionnaire.
SAGIS is a suitable questionnaire to assess gastrointestinal complaints like Decreased appetite, Diarrhea, Weight decreased, Gastroenteritis Abdominal pain, discomfort etc. It consists of 22 items as well as two open questions asking for the participant's most and second most important clinical problem. Q1 to Q22 are summed together to give a total symptom burden score. The total symptoms burden score can range from 0 to 88.The number of items between Q1 and Q22 that are scored severe (3) or very severe (4) are added together. The global impact score can range from 0 to 22.
Time frame: Day 0, Day 90, and Day 180
To evaluate the efficacy of VL-SE-01 on the basis of Sleep quality using the PSQI questionnaire
The questions relate to a person's usual sleep habits during the past month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). All the seven component scores are to be added together for calculating the Global PSQI Score. Higher scores indicate worse sleep quality.
Time frame: Day 0, Day 90, and Day 180
To evaluate the efficacy of VL-SE-01 on the basis of Insomnia using Insomnia Severity Index (ISI)
The questionnaire evaluates the sleep quality in last two weeks. The seven answers are added up to the total score.The scores of 0-7 determines no clinically significant insomnia, 8-14 determines sub threshold insomnia, 15-21 has moderate severity which determines clinical insomnia and lastly 22-28 has severe insomnia.
Time frame: Day 0, Day 90, and Day 180
To evaluate the efficacy of VL-SE-01 on the basis of Fatigue will be assessed using fatigue severity scale (FSS)
The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 indicates strong agreement, and the final score represents the mean value of the 9 items. A visual analogue scale is also included with the scale in which the respondents will be asked to denote the severity of their fatigue at the present moment by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue
Time frame: Day 0, Day 90, and Day 180
To evaluate the efficacy of VL-SE-01 on the basis of Stress response as assessed by Perceived Stress Scale (PSS).
The questions in this scale ask about feelings and thoughts of an individual during the last month. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress
Time frame: Day 0, Day 90, and Day 180
To evaluate the efficacy of VL-SE-01 on the basis of Menstrual cycle regularity.
A diary will be provided to the participant to record their monthly menstruation period start date and stop date. The average length of a menstrual cycle is of 28 days, however it varies for every female.
Time frame: Day 0, Day 90, and Day 180
To evaluate the efficacy of VL-SE-01 on the basis of Plasma levels of CBD and its metabolites [7-Carboxy-cannabidiol (7-COOH-CBD) and 7-Hydroxy-cannabidiol (7-OH-CBD)]
This will be conducted in 15 participants only in each group except placebo.
Time frame: 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours at Day 0, Day 90, Day 180