CTRI/2025/08/093409
尚未招募
Post Marketing Surveillance
A Clinical Study to Evaluate the Efficacy of Baljeevan Syrup as an Immunity Booster in Children aged 4-9 years old- An Open labelled, Double arm, Multi centric, Comparative, Post-Marketing Survillence Study (Phase IV) Clinical Study
Rashtriya Shikshan Mandals Research Institute of Health Sciences and Management Pune2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月30日最近更新:
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- Rashtriya Shikshan Mandals Research Institute of Health Sciences and Management Pune
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1.Reduction in frequency of respiratory allergic episodes.
概览
简要总结
An open-labelled, double-arm, multicentric, Phase IV post- marketing surveillance study to assess the efficacy and safety of Baljeevan Syrup as an Immunity booster in children aged 4-9 years. The trial compares Baljeevan Syrup with standard care in improving immune status, reducing frequency and severity of infections, and ensuring safety in the pediatric population.
研究设计
- 研究类型
- Pms
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 4 to 9 years old.
- •2.Clinically diagnosed with recurrent respiratory allergic disorders.
- •Parents/guardians willing to provide written informed consent for participation.
排除标准
- •Children below 4 years or above 9 years of age.
- •2.Known cases of congenital heart disease, chronic kidney disease, diabetes, or tuberculosis.
- •3.Known cases of systemic disorders.
- •4.Known cases of immunodeficiency disorders.
- •5.Currently undergoing steroid treatment or immunosuppressive therapy.
- •6.Participation in any other clinical study within 3 months prior to screening for the present study.
- •7.Other conditions, which in the opinion of the investigators, render the patient unsuitable for enrolment or could interfere with adherence to the study protocol.
- •8.Inability or unwillingness of the parent/guardian to adhere to the follow-up schedule or instructions.
结局指标
主要结局
1.Reduction in frequency of respiratory allergic episodes.
时间窗: Baseline, end of 6th month
次要结局
- 1. Changes in immunological markers like IgE, IL6, IL10.(Baseline, end of 6th month)
- 2.Improvement in general Health parameters.(Every Visit)
- 3.Safety and tolerability of Baljeevan Syrup.(Every Visit)
研究者
Dr Kalpana Dhuri
Dr D Y Patil Deemed to be University, School of Ayurveda, Nerul-Navi Mumbai
研究点 (2)
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