CTRI/2014/01/004304已完成2 期
An Open Label, Randomized, Comparative, Parallel Group, Multi Center, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of â??AHPL/AYTOP/0113â?? in Comparison with â??Framycetin sulphate Creamâ?? in Acute Wounds - NI
Ari Healthcare Pvt Ltd R D Centre0 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
- •1.Subjects that agree to have their wound photographed for the trial.
- •2.Healthy male and female subjects of 18 to 50 years of age.
- •3.Subjects having acute wounds (less than 6 hours of occurrence).
- •4.Subjects with partial or full thickness skin wounds between greater than or equal to 1.0 and less than or equal to 16.0 cm² area
- •5.Subjects ready to take injection TT before application of study drug.
- •6.Subjects are willing to make all required study visits.
- •7.Subjects are willing to follow instructions in the opinion of the Investigator.
排除标准
- •1.Subjects having a known hypersensitivity to any of the trial medicines or their components.
- •2.Subjects who have received treatment (another investigational agent) within last thirty (30) days from Screening/Baseline Visit.
- •3.Pregnant and lactating women.
- •4.Women with child bearing age and who refuse to use effective contraceptive methods.
- •5.Subjects having clinical evidence of moderate to severe bacterial or fungal infection of the wound as per visual/clinical assessment.
- •6.Conditions that would interfere with wound healing (diabetes and hypertension).
- •7.In the opinion of Investigator/Co-investigator, there is need of wound closure (by suturing, etc.) and/or dressing of wound.
- •8.Subject, who has used any kind of medicines (local application and/or oral medication) for wound within 6 hours prior to Screening/Baseline Visit.
- •9.Subjects with known immunological, hematologic disorders or metastatic malignancy.
- •10.Subjects having known neurological or psychiatric pathologies.
- •11.Subjects who have received chemotherapy or radiation therapy within the past 5 years.
- •12.Subjects on NSAIDs.
- •13.For pain management patients will be advised to take only tablet paracetamol up to 2 gm/day.
- •14.Subjects who have received treatment with glucocorticoids for > 10 consecutive days within 6 months prior to screening/baseline visit.
- •15.Subjects on systemic or topical antibiotics or systemic therapy with cytotoxic drugs.
- •16.Subjects having severe edema on the treatment/target part.
- •17.Subjects with known history of HIV/AIDS.
- •18.Alcoholic and Smoker.
研究者
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