None listed
Conditions
Interventions
Intervention1: Nanosoma Nano emulsion spray (2.5 mg policosanol per 5 sprays): Nano Soma Water Soluble Policosanol 30ml per bottle with 2.5 mg per 5 sprays Batch No. : 019PN020720 Manufacturing date :
Sponsors
DrPRRaghavan
Eligibility
Inclusion criteria
Inclusion criteria: The subjects will be selected for study participation, if they meet the following criteria: Healthy willing adult male human volunteer should have: � An age between 18 to 45 years (both inclusive), having body mass index (BMI) between 18.5 and 30 Kg/m2, weighing not less than 45 kg � No medical history of significant diseases � A physical examination, laboratory evaluations are clinically insignificant � A negative or non-reactive Rapid Plasma Reagin (RPR), Hepatitis B Surface Antigen (HBsAg), Hepatitis C (Anti HCV), antibodies to human immune-deficiency Virus (HIV) I and II � A negative breath alcohol test � A negative urine test for drugs of abuse � Normal or clinically insignificant chest area on auscultation (X-ray, if needed). � Vital signs examination that are within clinically acceptable limits � No significant medical complaints � No clinical abnormalities in CBC, Body temperature and Respiratory rate. � COVID -19 Antibody Test is negative at each subsequent visit to the study site. � Female subjects should be Non-pregnant and Non-lactating.
Exclusion criteria
Exclusion criteria: The subjects will be excluded from the study, if they meet any of the following criteria: ââ?¬Â¢ Known hypersensitivity to any inactive ingredients or related drugs in IP. ââ?¬Â¢ History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. ââ?¬Â¢ Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. ââ?¬Â¢ History or presence of significant alcoholism or drug abuse in the past one year. ââ?¬Â¢ History or presence of significant smoking (more than 10 cigarettes or beediââ?¬•s/day or consumption of tobacco products). ââ?¬Â¢ History or presence of significant asthma, urticaria or other allergic reactions. ââ?¬Â¢ History or presence of significant gastric and/or duodenal ulceration. ââ?¬Â¢ History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. ââ?¬Â¢ History or presence of cancer. ââ?¬Â¢ History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc. ââ?¬Â¢ Presence of disease markers of HIV1 or 2, Hepatitis A, B or C viruses and syphilis. ââ?¬Â¢ Difficulty with donating blood. ââ?¬Â¢ Difficulty in swallowing solids like Lozenges or capsules. ââ?¬Â¢ Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. ââ?¬Â¢ Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. ââ?¬Â¢ Pulse rate less than 60/minute or more than 100/minute. ââ?¬Â¢ Oral temperature less than 35oC or more than 37.5oC. ââ?¬Â¢ Respiratory rate less than 12/minute or more than 20/minute ââ?¬Â¢ Use of any prescribed medication during last two weeks or OTC medicinal products and grapefruit juice and 48hrs prior to initiation of study. ââ?¬Â¢ Major illness during 3 months before screening. ââ?¬Â¢ Participation in a drug research study within past 3 months. ââ?¬Â¢ Donation of blood in the past 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ To assess and compare the immunomodulating efficacy of a formulation containing 2.5 mg Policosanol in male and female human subjects. ââ?¬Â¢ To assess the immunomodulation efficacy using IgG, IgE, IgM and IgA, levels measured both before and after treatment with IPs. ââ?¬Â¢ To assess the changes in levels of Oxidative Enzymes, Vitamin C and Phosphorous before and after treatment with the IPs. ââ?¬Â¢ To record the changes in Ferritin, CRP and Vitamin D3before and after treatment of IP. Timepoint: Zero day, Day 07 and Day 31 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ To evaluate the safety and tolerability of the formulation of Nano Soma containing 2.5 mg Policosanol by evaluating the liver and kidney functions both before and after treatment with IPs.Timepoint: Zero day, Day 07 and Day 31 | — |
Countries
India
Contacts
Public ContactDrSasikumar Menon
Institute for Advanced Training and Research in Interdisciplinary Sciences
Outcome results
None listed