Assessment of Immune Modulation after use of NANO SOMA

Phase 4

Completed

• Registration Number: CTRI/2021/10/037180
• Lead Sponsor: DrPRRaghavan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-26
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

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

The subjects will be excluded from the study, if they meet any of the following criteria:

�Known hypersensitivity to any inactive ingredients or related drugs in IP.

�History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

�Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.

�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).

�History or presence of significant asthma, urticaria or other allergic reactions.

�History or presence of significant gastric and/or duodenal ulceration.

�History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.

�History or presence of cancer.

�History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.

�Presence of disease markers of HIV1 or 2, Hepatitis A, B or C viruses and syphilis.

�Difficulty with donating blood.

�Difficulty in swallowing solids like Lozenges or capsules.

�Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.

�Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.

�Pulse rate less than 60/minute or more than 100/minute.

�Oral temperature less than 35oC or more than 37.5oC.

�Respiratory rate less than 12/minute or more than 20/minute

�Use of any prescribed medication during last two weeks or OTC medicinal products and grapefruit juice and 48hrs prior to initiation of study.

�Major illness during 3 months before screening.

�Participation in a drug research study within past 3 months.

�Donation of blood in the past 3 months before screening.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
�To assess and compare the immunomodulating efficacy of a formulation containing 2.5 mg Policosanol in male and female human subjects. <br/ ><br> <br/ ><br>�To assess the immunomodulation efficacy using IgG, IgE, IgM and IgA, levels measured both before and after treatment with IPs. <br/ ><br> <br/ ><br>�To assess the changes in levels of Oxidative Enzymes, Vitamin C and Phosphorous before and after treatment with the IPs. <br/ ><br> <br/ ><br>�To record the changes in Ferritin, CRP and Vitamin D3before and after treatment of IP. <br/ ><br>Timepoint: Zero day, Day 07 and Day 31

Secondary Outcome Measures

Name	Time	Method
�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