CTRI/2014/08/004918已完成4 期
A Phase IV, Monocentric, Open Label, Clinical Study to Evaluate the Efficacy and Safety of AphtoFix® Mouth Ulcer Cream Manufactured by Bonyf AG in Subjects Sufferingfrom Mouth Ulcer.
Bonyf AG0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
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
- •1. Male or female subjects with 18 â?? 65 years of age (both
- •inclusive).
- •2. Subjects having mouth ulcer size >2 mm in locations for easily
- •accessible for evaluation and treatment.
- •3. Subject with time of onset of mouth ulceration within 48 hours.
- •4. Subject who agreed, not to use any other medication to treat
- •mouth ulcer during study period.
- •5. Subject willingness to comply with the study schedule and
- •procedures.
- •6. Subject / legally acceptable representative (LAR) of subject
- •willing to sign and date written informed consent to participate
- •in the study. However, if the subject/LAR of subject is illiterate,
- •the impartial witness would sign the ICF.
排除标准
- •1. Subjects with a history of allergy for content present in
- •2. Subjects with any invasive dental procedures within 2 weeks
- •prior to screening visit.
- •3. History of uncontrolled chronic disease (e.g. chronic liver
- •disease, chronic renal disease)
- •4. Use of any other medication to treat mouth ulcer in current
- •5. Participation in any other clinical study during last 30 days.
- •6. Subject with any condition which in the opinion of the
- •investigator makes the subject unsuitable for inclusion.
- •7. Subject is a female who is pregnant or willing to get pregnant,
- •not ready to use contraceptive measures during the trial period,
- •or is breast feeding.
研究者
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