CTRI/2020/09/027657已完成2 期
A Prospective, Interventional, Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii 088AE, ImmunoSEB and a combination of Bacillus clausii 088AE plus Bacillus coagulans LBSC plus Bacillus subtilis PLSSC as immunomodulators in Acute Allergic Rhinitis
Advanced Enzyme Technologies Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects who have given written informed consent to participate in the study.
- •2. Subjects of either sex aged between 18 to 65 years (both inclusive) with acute allergic rhinitis.
- •3. At the time of the enrolment subject should have an investigator assessed:
- •A. Total Four Nasal Symptom Score of 4 -10 (both inclusive) with minimum nasal stiffness score of 2.
- •B. Total Two Ocular Symptom Score of 1 â?? 5 (both inclusive)
- •C. Cough with a score of 0-1 in a 4-point scale.
排除标准
- •1.Subjects with history of hypersensitivity to antihistamines or any of the excipients of study formulations.
- •2.Subjects with nasal structural abnormalities (including deviated nasal septum, nasal polyps etc.)
- •3.Subjects using nasal sprays or with nasal, ocular, sinus surgery in past 6 months.
- •4.Subjects with history of disorders of nasolacrimal drainage.
- •5.Subjects with rhinitis medicamentosa (defined as a condition characterized by nasal congestion without rhinorrhoea or sneezing that is triggered by the use of topical nasal decongestants for more than 4-6 days).
- •6.Subjects receiving immunotherapy for at least 6 months prior to enrollment in this study.
- •7.Subjects who have received intranasal/systemic corticosteroids in the past 4 weeks or cromolyn sodium in the last 2 weeks or are having any antibiotic therapy.
- •8.Subjects who would be requiring concomitant chronic or intermittent use of oral, intravenous, intramuscular, topical or inhaled corticosteroids.
- •9.Subjects with significant disease(s) or disorder(s) other than seasonal allergic rhinitis that in the opinion of the investigator may
- •(i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or
- •(iii) cause concern regarding subjectâ??s ability to participate in the study.
- •10.Subjects with history of substance abuse
- •11.Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive serum pregnancy test at screening.
- •12.Subjects who are unable or unwilling to comply with the study procedures.
- •13.Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
- •14.Subjects who are likely to travel outside the study area for a substantial portion of the study period.
- •15.Subjects with self-reported chronic diseases like diabetes, kidney diseases, cardiovascular disease
- •16.Subjects on treatment with any kind of CNS disease (self-reported).
研究者
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