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
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Efficacy of the Investigational Product will be evaluated using Bates-Jensen Wound Assessment Tool (BJWAT)
研究概览
简要总结
Wound healing is a critical aspect of medical care, and the exploration of effective therapeutic interventions remains a significant area of research. Among the various approaches, polyherbal medicines have gained attention for their potential in promoting wound healing. Dvija Heal+, a polyherbal medicine, is one such formulation that has shown promise in clinical settings. The need to thoroughly study its wound healing effects arises from the increasing demand for alternative and complementary treatments. Additionally, the efficacy of traditional wound care formulations, such as framycetin cream and Jatyadi tail, has been acknowledged, prompting further investigation into their mechanisms and outcomes. This study aims to contribute to the existing body of knowledge by comprehensively assessing the wound healing properties of Dvija Heal+ and comparing its effectiveness with framycetin cream and Jatyadi tail. Such a comparative analysis is crucial for clinicians and researchers seeking evidence-based recommendations for optimal wound care, potentially leading to advancements in therapeutic strategies and improved patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are able to understand instructions and willing to give written informed consent and comply with study protocol.
- •Subjects who agree to have their wound photographed for trial.
- •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)
- •Subjects with superficial and partial thickness wound.
- •Wound size of less than 49 square centimetre.
- •The subject is willing to complete all follow-up evaluations required by the study protocol.
排除标准
- •Subjects having a known hypersensitivity to any of the trial medicines or their components.
- •Subjects who have received treatment (another investigational agent) within last thirty days from Screening or Baseline Visit.
- •Subjects are not willing to give informed consent.
- •Pregnant and lactating women.
- •Pediatric subjects.
- •Subjects having clinical evidence of moderate to severe bacterial or fungal infection of the wound as per visual or clinical assessment.
- •Subjects with wound requiring closure by suturing, etc.
- •and or dressing, in the opinion of Investigator or Coinvestigator.
- •Subjects on any other conservative treatment which influences the study results.
- •Subjects with any underlying serious medical illness.
- •Subjects with full thickness wound beyond subcutaneous layer.
- •Subjects with known immunological, hematologic disorders or metastatic malignancy.
- •Subjects having known neurological or psychiatric pathologies.
- •Subjects who have received chemotherapy or radiation therapy within the past 5 years.
- •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.
- •Subjects on NSAIDs.
- •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.
- •Subjects having severe edema on the treatment target part.
结局指标
主要结局
Efficacy of the Investigational Product will be evaluated using Bates-Jensen Wound Assessment Tool (BJWAT)
时间窗: Baseline, Day 2, Day 4, Day 7, Day 10, Day 14, Day 17 and Day 21 or the Day of complete healing of wound (whichever is earlier).
次要结局
- 1. Surface area of wound(2. Different parameters of wound assessment as components of Bates-Jensen Wound Assessment Tool (BJWAT))
研究者
Dr Hemant Toshikhane
Parul Institute of Ayurved