CTRI/2021/10/037180已完成4 期
Assessment of Immune Modulation after treatment with a formulation of Nano Soma developed by Nanorx Inc., U.S.A., containing 2.5 mg policosanol in Twelve male and Twelve female human subjects in a Balanced, Randomized, parallel design, efficacy study
DrPRRaghavan0 个研究点目标入组 26 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •The subjects will be selected for study participation, if they meet the following criteria:
- •Healthy willing adult male human volunteer should have:
- •Ã¢â?¬Â¢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
- •Ã¢â?¬Â¢No medical history of significant diseases
- •Ã¢â?¬Â¢A physical examination, laboratory evaluations are clinically insignificant
- •Ã¢â?¬Â¢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
- •Ã¢â?¬Â¢A negative breath alcohol test
- •Ã¢â?¬Â¢A negative urine test for drugs of abuse
- •Ã¢â?¬Â¢Normal or clinically insignificant chest area on auscultation (X-ray, if needed).
- •Ã¢â?¬Â¢Vital signs examination that are within clinically acceptable limits
- •Ã¢â?¬Â¢No significant medical complaints
- •Ã¢â?¬Â¢No clinical abnormalities in CBC, Body temperature and Respiratory rate.
- •Ã¢â?¬Â¢COVID -19 Antibody Test is negative at each subsequent visit to the study site.
- •Ã¢â?¬Â¢Female subjects should be Non-pregnant and Non-lactating.
排除标准
- •The subjects will be excluded from the study, if they meet any of the following criteria:
- •Ã¢â?¬Â¢Known hypersensitivity to any inactive ingredients or related drugs in IP.
- •Ã¢â?¬Â¢History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Ã¢â?¬Â¢Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •Ã¢â?¬Â¢History or presence of significant alcoholism or drug abuse in the past one year.
- •Ã¢â?¬Â¢History or presence of significant smoking (more than 10 cigarettes or beediââ?¬•s/day or consumption of tobacco products).
- •Ã¢â?¬Â¢History or presence of significant asthma, urticaria or other allergic reactions.
- •Ã¢â?¬Â¢History or presence of significant gastric and/or duodenal ulceration.
- •Ã¢â?¬Â¢History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •Ã¢â?¬Â¢History or presence of cancer.
- •Ã¢â?¬Â¢History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
- •Ã¢â?¬Â¢Presence of disease markers of HIV1 or 2, Hepatitis A, B or C viruses and syphilis.
- •Ã¢â?¬Â¢Difficulty with donating blood.
- •Ã¢â?¬Â¢Difficulty in swallowing solids like Lozenges or capsules.
- •Ã¢â?¬Â¢Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
- •Ã¢â?¬Â¢Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Ã¢â?¬Â¢Pulse rate less than 60/minute or more than 100/minute.
- •Ã¢â?¬Â¢Oral temperature less than 35oC or more than 37.5oC.
- •Ã¢â?¬Â¢Respiratory rate less than 12/minute or more than 20/minute
- •Ã¢â?¬Â¢Use of any prescribed medication during last two weeks or OTC medicinal products and grapefruit juice and 48hrs prior to initiation of study.
- •Ã¢â?¬Â¢Major illness during 3 months before screening.
- •Ã¢â?¬Â¢Participation in a drug research study within past 3 months.
- •Ã¢â?¬Â¢Donation of blood in the past 3 months before screening.
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