CTRI/2025/07/089984尚未招募不适用
A Proof of Concept, Randomized, Double Blind, Placebo Controlled Clinical Trial to Assess the Effect of GH-LS-R1 on Respiratory Health and Quality of Life in Individuals Exposed to High Pollution.
Verisearch Lab1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Improvement in the lung’s capacity as indicated by higher increase in the Tiffeneau-Pinelli index (FEV1/FVC ratio) from baseline to EOS, as compared to placebo.
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled clinical trial evaluating the effect of a GH-LS-R1 on respiratory health. The study includes healthy adults aged 18–60 who are frequently exposed to high levels of air pollution and report related breathing symptoms. Participants will take one capsule daily for 28 days and undergo assessments like lung function tests, stool pH, hydration status, and symptom questionnaires. The study aims to measure improvements in lung capacity, symptom relief, gut health, and overall hydration. Safety will be monitored through vital signs, blood tests, adverse event tracking, and regular medical check-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Individuals working outdoors for more than equal to 2 years with at least 8 hours of working time in pollution heavy area.
- •Systolic blood pressure less than equal to
- •Individuals with complains of one or more of the listed respiratory problems which includes cough, breathlessness, fatigue and/or sneezing due to exposure to pollution, at least once every 2 weeks.
- •Individuals with FEV1 by FVC ratio greater than equal to 0.5 and less than equal to 0.
- •Individuals with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
- •RBC count Less than normal (Normal Value Male 4.5 to 6.5 mil by cmm; Female 4 to 5.4 mil by cmm).
排除标准
- •Individuals with FEV1 by FVC ratio less than 0.
- •History of gastroenteritis in the past month Usage of hormones and steroids in 60 days before entering the study.
- •Usage of antibiotics in 15 days before entering the study.
- •Usage of nasal spray or other probiotics (such as lactic acid bacteria, Bifidobacterium) in the last one month.
- •Lymph node enlargement, inflammation, polyps, mass, runny nose, etc., after clinical examination of lips, throat, ears, nostrils, and neck Clinically significant GI condition (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose and gluten intolerance or allergies).
- •Recent (within 2 weeks of screening) history of an episode of acute GI illness such as nausea/vomiting or diarrhoea (defined as greater than equal to 3 loose or liquid stools/day) Individuals with history of gastrointestinal surgery Long history of drug use Individuals with history of smoking in the past 5 years or currently smoking or using any form of tobacco.
- •Post-menopausal women Pregnant and/ or lactating females Inability to understand and cooperate with the study process.
- •Participated in other clinical trials within the past month.
结局指标
主要结局
Improvement in the lung’s capacity as indicated by higher increase in the Tiffeneau-Pinelli index (FEV1/FVC ratio) from baseline to EOS, as compared to placebo.
时间窗: Day 0 to Day 28
次要结局
- NA(NA)
研究者
Dr Sagar Kamble
Jejurikar’s Health Care
研究点 (1)
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