CTRI/2025/06/088564招募中不适用
A Randomized, Double-blind, Placebo-controlled, Parallel Clinical study to assess the effect of ProGenr8 (Probiotic Supplement) on Immune Health in Teachers prone to Upper Respiratory Tract Infection (URTI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- To assess the effect of the 120 days’ administration of ProGenr8™ on % population having one or more episodes of URTI during the study duration as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire – 21 (WURSS – 21) as compared to baseline and placebo.
研究概览
简要总结
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179 individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%, approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 100 completed participants i.e. 50 participants in each study arm after accounting for a dropout/withdrawal rate of 30% at the end of the study. The intervention and follow-up duration for all the study participants will be 120 days.
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals ready to give voluntary, written informed consent to participate in the study.
- •Male and female teachers aged between 18 to 50 years’ (both values included) with moderate physical activity level as per International Physical Activity Questionnaire – Short Form (IPAQ.
- •Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2
- •High susceptibility to URTIs at least once every three months for last 1 year (at least 4 to 6 episodes in a year). 5.Individuals who have active URTI episode at screening defined as “those having a score of less than equal to 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough or head congestion on the WURSS-21”.
- •Commitment to adhere to routine diet and physical activity.
- •Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E, etc.) at least 1 one month prior to screening.
- •Willing to discontinue sleep medications at least 1 month prior to screening and during the entire study duration.
- •Individuals willing to complete all study-related and clinical study visits as per the protocol.
排除标准
- •1.Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc
- •Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 month prior to screening.
- •Individuals with known sensitivity to the investigational products or any excipients of the product.
- •Individuals with any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc.).
- •Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
- •Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, and vapor rub, etc.
- •7.Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose less than equal to 126 mg per dL.
- •8.Individuals with uncontrolled hypertension on medication and with systolic blood pressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.
- •Individuals who are unable to abstain from herbal or dietary supplements for URTI throughout the study period.
- •Vaccination against influenza or swine flu within 90 days prior to screening.
- •Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDs, or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.
- •History of any significant neurological and psychiatric condition which may affect the participation and inference of the study’s end points.
- •Individuals with substance abuse problems (within 2 years) defined as: a) Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence.
- •b) High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men.
- •Individuals who have clinically significant following severe illness
- •Females who are pregnant/planning to be pregnant or lactating or taking any oral contraceptives.
- •Any condition that could, in the opinion of the investigator, preclude the individual’s ability to successfully and safely complete the study or that may confound study outcomes.
结局指标
主要结局
To assess the effect of the 120 days’ administration of ProGenr8™ on % population having one or more episodes of URTI during the study duration as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire – 21 (WURSS – 21) as compared to baseline and placebo.
时间窗: Throughout the study during episodes
次要结局
- To assess the effect of ProGenr8™ in comparison to baseline and placebo on:(-Severity of the URTI episodes as assessed by WURSS – 21.)
- To assess the effect of ProGenr8™ in comparison to baseline and placebo on:(-Satiety as assessed by Hunger Satiety Scale (HSS).)
- To assess the effect of ProGenr8™ in comparison to baseline and placebo on(-Body composition (Fat tissue, lean mass, fat free mass) as assessed by Dual Energy X-ray Absorptiometry (DEXA).)
研究者
Dr Sanjay Vaze
Vedic Lifesciences Pvt Ltd
研究点 (8)
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