CTRI/2024/02/062769招募中2 期
A Randomized, Prospective, Comparative, Interventional, Three- Arm, Clinical Trial to Evaluate Efficacy and Safety of Topical Dvija Heal+ in comparison with 1% w/w Framycetin Cream (1% w/w) and Jatyadi Tel in Acute Wounds - Nil
Dvija Naturals Pvt Ltd0 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
- 2 期
- 状态
- 招募中
- 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. Subjects who are able to understand instructions and willing to give written informed consent and comply with study protocol.
- •2. Subjects who agree to have their wound photographed for trial.
- •3. Subjects with wounds caused by trauma/ Burns (localized burns), Diabetic foot, bed sores, other co- morbid condition, post-operative wound etc. (within 7 days of occurrence)
- •4. Subjects with superficial and partial thickness wound.
- •5. Wound size of less than 49 square centimetre.
- •6. The subject is willing to complete all follow-up evaluations required by the study protocol
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 days from Screening or Baseline Visit.
- •3. Subjects are not willing to give informed consent.
- •4. Pregnant and lactating women.
- •5. Pediatric subjects.
- •6. Subjects having clinical evidence of moderate to severe bacterial or fungal infection of the wound as per visual or clinical assessment.
- •7. Subjects with wound requiring closure by suturing, etc. and or dressing, in the opinion of Investigator or Coinvestigator.
- •8. Subjects on any other conservative treatment which influences the study results.
- •9. Subjects with any underlying serious medical illness.
- •10. Immunocompromised and non- cooperative subjects and or known history of HIV AIDS.
- •11. Subjects with full thickness wound beyond subcutaneous layer.
- •12. Subjects with known immunological, hematologic disorders or metastatic malignancy.
- •13. Subjects having known neurological or psychiatric pathologies.
- •14. Subjects who have received chemotherapy or radiation therapy within the past 5 years.
- •15. Subject, who has used any kind of medicines local application and or oral medication for wound within 6 hours prior to Screening or Baseline Visit.
- •16. Subjects on NSAIDs.
- •17. Subjects who have received treatment with glucocorticoids for more than 10 consecutive days within 6 months prior to screening or baseline visit or oral corticosteroid with dose more than 10mg per day.
- •18. Subjects on systemic or topical antibiotics or systemic therapy with cytotoxic drugs.
- •19. Subjects having severe edema on the treatment target part.
研究者
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