CTRI/2022/06/043331已完成2 期
A prospective, randomized, double-blind, placebo-controlled clinical study for the assessment of immunomodulatory properties of KaraShield on general healthy population.
Green Chem2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of clinically confirmed episodes of Upper Respiratory Tract Infection (URI) related symptoms measured through Wisconsin Upper Respiratory Symptom Survey (WURSS-24) Score
研究概览
简要总结
This proposed study is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of KaraShieldTM versus placebo in improving the general immunity in otherwise healthy population aged between 18 to 60 years. The observed outcomes through primary and secondary endpoints results will be analysed to check the safety and efficacy of this synergistic herbal formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Healthy male and female subjects between the age groups of 18–60 years, who have a history of recurrent (at least 2 episodes and above in the last 2 months) upper respiratory tract infection (URI) and related symptoms such as common cold, cough, sore (scratchy) throat, nasal discharge (runny nose), nasal obstruction (plugged or congested), sneezing, headache, low-grade fever (malaise), tiredness/bodyache, chillness, etc.
- •due to common cold and/ or seasonal change-related immunity disorders (except the allergic conditions) and/ or who have lower value of normal range for IgG at the time of study participation (baseline) (Normal range of IgG in adult: 600–1600 mg/dL or, 6-16 g/L).
- •â€¢ Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
排除标准
- •â€¢ Subjects with the current habit or history of cigarette smoking.
- •â€¢ Subjects with the current habit of alcohol consumption more than 2 standard drinks/ day.
- •â€¢ Subjects with very high level of IgE <700 KU/L (allergic patient) • Subjects with the confirmed case of pneumonia or bronchitis.
- •â€¢ Subjects with allergic rhinitis, sinusitis/ Pharyngitis or any other oropharyngeal disorder.
- •â€¢ Subjects who underwent or need tonsillectomy or adenoidectomy.
- •â€¢ Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc.
- •â€¢ Subjects suffering from proteinuria (loss of protein in urine).
- •â€¢ Subjects on any seizure medication.
- •â€¢ Subjects on any other medication known to reduce IgG levels.
- •â€¢ Subjects with a known history of any malignant disease.
- •â€¢ Subjects with known history of autoimmune disease and other systemic diseases related to immune system.
- •â€¢ Subjects with chronic immune diseases like HIV.
- •â€¢ Subjects suffering with the infectious diseases HBsAg and HCV • Subjects treated with the following medications: a)Antibiotics less than one week before the study b)Any vaccination less than 4 weeks before the study c)Concomitant immunosuppressive or immune-stimulating therapy 3 months before the study start.
- •â€¢ Subjects with concomitant treatment with corticosteroids.
- •â€¢ Subjects who participated in another clinical trial less than 3 months prior to this study.
- •â€¢ Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period.
- •â€¢ Subjects with the history of consumption of any recreational drugs (such as cocaine, methamphetamine, marijuana, etc).
- •â€¢ Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic • Subjects with inability or unwillingness to abide by the requirements of the protocol.
- •â€¢ Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
Incidence of clinically confirmed episodes of Upper Respiratory Tract Infection (URI) related symptoms measured through Wisconsin Upper Respiratory Symptom Survey (WURSS-24) Score
时间窗: Day 0, Day 7, Day 15, Day 30, Day 60
次要结局
- Mean symptoms severity score of WURSS-24 Score(Day 0, Day 7, Day 15, Day 30, Day 60)
- Immunoglobulin G (IgG) Level(Day 0,Day 60)
- Immunity status Questionnaire (ISQ) Score(Day 0, Day 7, Day 15, Day 30, Day 60)
- Immunity panel-CD3, CD4 & CD8 Count(Day 0,Day 60)
- WHO-Quality of Life (WHOQOL-BREF)(Day 0,Day 60)
- Inflammatory Biomarker-C-Reactive Protein (CRP)(Day 0,Day 60)
- Laboratory Safety Parameters(Day 0,Day 60)
研究者
研究点 (2)
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