CTRI/2024/12/077632已完成不适用
An Investigation of the Safety and Effectiveness of an Oral Supplementation of Bio-Immune® for Managing Upper Respiratory Tract Infection and its symptoms: A Prospective, Interventional, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Science Study.
Ambe Phytoextracts Pvt. Ltd.2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年12月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 1. To assess the effect of the test treatment on symptom severity and functional impairment scores as measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) questionnaire, compared to placebo.
研究概览
简要总结
This is a prospective, interventional, randomised, double-blind, placebo-controlled, proof-of-science, in-use safety and efficacy study of an oral supplementation of Bio-Immune® for managing upper respiratory tract infection and its symptoms.
· Visit 1: Screening, evaluations for inclusion.
· Visit 2: Enrolment, baseline and post-baseline evaluations, treatment commencement.
· Visit 3: Test treatment usage phase, follow-up evaluations.
· Visit 4 : Test treatment usage phase, follow-up evaluations.
· Visit 5 : End-of-study visit, follow-up Evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •The age of subject is more than or equal to 30 years and less than 80 years.
- •The subject is a healthy male or a healthy adult non-pregnant and non-lactating female.
- •The subject is suffering from uncomplicated URTI characterized by symptoms such as cough, nasal discharge, sore throat, or has had the first fever spike within 48 hours of enrolment.
- •The subject must be willing to comply with all study procedures and restrictions, including taking the test treatment as directed, completing the WURSS-21 questionnaire, and undergoing laboratory assessments.
- •The subject must provide written informed consent prior to participation in the study.
- •The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
- •If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
- •Females of childbearing potential must practice and maintain an established method of birth control (IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- •Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
排除标准
- •The subject is currently diagnosed with active respiratory infections or diseases other than uncomplicated URTI that might require immediate medical attention or intervention will be excluded.
- •The chest X-ray of the subject, performed within the past 28 days, reveals significant respiratory disorders or other serious conditions that might interfere with the study or necessitate medical intervention.
- •Laboratory tests (blood and urinalysis) performed at the screening visit reveal significant infective or other serious conditions that could interfere with the study or necessitate medical intervention.
- •The subject has known immunocompromising conditions such as HIV/AIDS, or those undergoing immunosuppressive therapy.
- •The subject has other significant respiratory diseases (COPD, asthma, interstitial lung disease, active tuberculosis).
- •The subject has uncontrolled or severe cardiovascular, renal, or hepatic conditions.
- •The subject has participated in any other clinical trial within 30 days prior to the screening visit.
- •The subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
- •The subject has known hypersensitivity or allergies to any component of the test treatment or similar botanical extracts are excluded.
- •The subject is on regular medications known to interfere with the study outcomes (systemic corticosteroids, antiviral drugs) within 4 weeks before screening are excluded.
- •The subject has any condition that, in the investigator judgment, would compromise the subject safety or study integrity.
结局指标
主要结局
1. To assess the effect of the test treatment on symptom severity and functional impairment scores as measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) questionnaire, compared to placebo.
时间窗: scores on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5.
2. To assess the effect of the test treatment on the overall symptom burden of the common cold, as determined by the Area Under the Curve (AUC) for the WURSS-21 symptom, functional impairment, and global scores, compared to placebo.
时间窗: scores on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5.
次要结局
- To assess the effect of the test treatment on symptoms (such as cough, expectoration, nasal discharge, headache, fever, sore throat, earache, and malaise/fatigue), using a Visual Analogue Scale (VAS), compared to placebo(on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5.)
- To assess the effect of the test treatment on symptoms (such as cough, expectoration, nasal discharge, headache, fever, sore throat, earache, and malaise/fatigue), using the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.(on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5)
- To assess the effect of the test treatment on daily nasal discharge in terms of nasal mucus weight measured using pre-weighed paper tissues, compared to placebo.(on Day 1 (before administration) for baseline, and later on Day 2, and Day 3)
- To assess the safety of the test treatment by monitoring the occurrence of any adverse events throughout the study period.(To assess the safety of the test treatment by monitoring the occurrence of any adverse events throughout the study period.)
- To assess the safety of the test treatment based on changes in blood parameters, including Complete Blood Count (CBC).(on Day 1 (before administration) for baseline, and post-dosage on Day 3)
- To assess the effectiveness of the test treatment in altering C-reactive protein levels in blood, compared to placebo.(on Day 1 (before administration) for baseline, and post-dosage on Day 3)
- To assess the effectiveness of the test treatment in altering biomarkers including IL-8 and IgA in nasal wash sample, compared to placebo.(on Day 1 (before administration) for baseline, and post-dosage on Day 3)
- To assess the safety of the test treatment based on changes in blood parameters, including Serum Creatinine, SGPT, SGOT, Lipid Profile, RBS, Uric acid, and Urinalysis.(on Day 1 (before administration) for baseline, and post-dosage on Day 5)
研究者
Dr Vipul Sengal
NovoBliss Research Private Limited
研究点 (2)
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