A Randomized, Open- Label, Controlled Pilot Study to Evaluate the Efficacy and safety of wound Healing Herbal Ointment in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1. Assessment of wound healing over the study period using Bates- Jensen Wound Assessment Tool
研究概览
简要总结
Effective wound management is crucial, as impaired or delayed healing can lead to chronic wounds, infections, and significant morbidity. The use of herbal ointment/cream in wound management is rooted in ancient medical practices, where various plant extracts were applied to wounds to promote healing and prevent infection. Modern research has identified several bioactive compounds in these plants that possess antimicrobial, anti-inflammatory, and regenerative properties, which are conducive to wound healing. The rationale for this study is to scientifically evaluate the efficacy and safety of the Aloe wound cream in comparison to a betadine ointment, a standard treatment for wound care and a placebo cream without Aloe.
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
- •Healthy male and female subjects aged 18 to 50 years with acute wounds (occurring within the last 24 hours).
- •Subjects with superficial and partial thickness skin wounds up to 1 cm depth and 5 cm length.
- •Subjects ready to receive a tetanus toxoid (TT) injection before the application of the study drug at the discretion of the principal investigator (PI).
- •Subjects who agree to have their wound photographed during the trial.
- •Subjects willing to attend all required study visits.
排除标准
- •Subjects with infected wounds.
- •Individuals with visceral, bony, or spinal injuries.
- •Individuals with electrical, chemical, or burn injuries.
- •Subjects suffering from systemic diseases such as Diabetes mellitus, tuberculosis, malignant wounds, arterial or varicose ulcers, pressure ulcers, HbsAg positivity, HIV I & II positivity, or other conditions deemed by the investigator to potentially interfere with or delay the wound healing process.
- •Subjects with non-healing wounds/ulcers or infectious diseases.
- •Subject on any investigational drug(s) or therapeutic device(s) within 28 days preceding randomization.
结局指标
主要结局
1. Assessment of wound healing over the study period using Bates- Jensen Wound Assessment Tool
时间窗: Day 1, Day 7, Day 14
2. Assessment of the reduction in clinical symptoms of wound
时间窗: Day 1, Day 7, Day 14
3. Reduction of pain from baseline to end of the study
时间窗: Day 1, Day 7, Day 14
4. Assessment of time (number of days) required to achieve complete wound closure verified through photo documentation
时间窗: Day 1, Day 7, Day 14
次要结局
- 1. Assessment of skin tolerability throughout the study(2. Incidence of secondary infections during the study period)
研究者
Dr Rajendra Narayan Sharma
TrialGuna Private Limited