An Open-Label, Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of Sakriyam Oil in the Management of Open Wound Injuries.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Absolute and percentage change in wound length (cm) from Baseline to Day 7 and Day 15.
研究概览
简要总结
This study is designed to evaluate Sakriyam Oil, a proprietary Ayurvedic topical formulation, in adults aged 18 to 65 years with mild-to-moderate open wounds less than 72 hours old. Wound healing is a complex process, and disruptions can lead to delayed recovery, infection, pain, and reduced quality of life. Although standard wound care exists, there is a need for safe, effective, and symptom-relieving topical alternatives.
The purpose of this study is to assess the safety and efficacy of Sakriyam Oil in promoting wound healing. The study will measure changes in wound size (length and width), monitor healing progression through high-definition imaging, evaluate symptom improvement (redness, swelling, pain, itching, and pus formation) using patient-reported tools such as the Subject Global Assessment (SGA) and Visual Analogue Scale (VAS), and assess health-related quality of life using the EQ-5D-5L questionnaire.
The study aims to generate structured clinical evidence on the therapeutic benefits and tolerability of Sakriyam Oil, supporting its potential use as a safe and effective topical treatment for mild-to-moderate open wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female adults between 18 and 65 years of age.
- •Having mild-to-moderate open wound(s) less than 72 hours old at the time of screening.
- •Women of childbearing potential must be willing to practice an acceptable method of contraception for the duration of the study.
- •Willingness and ability to comply with all study procedures, visit schedules, and follow-up assessments.
排除标准
- •Pregnant, breastfeeding, or planning pregnancy during the study.
- •Deep or complicated wounds with exposed bone or muscle.
- •Presence of diabetic ulcers, infected wounds, or gangrenous tissue.
- •Participation in any other interventional clinical trial within the past 30 days.
- •Known hypersensitivity or allergy to any constituent of Sakriyam Oil.
- •Any significant concurrent illness or condition that, in the opinion of the Investigator, may interfere with study participation, safety, or data interpretation.
结局指标
主要结局
1. Absolute and percentage change in wound length (cm) from Baseline to Day 7 and Day 15.
时间窗: Screening & Baseline (Day 0), | Follow-up (Day 7 ±2), | End of Study (Day 15 ±2)
2. Absolute and percentage change in wound width (cm) from Baseline to Day 7 and Day 15.
时间窗: Screening & Baseline (Day 0), | Follow-up (Day 7 ±2), | End of Study (Day 15 ±2)
3. High-definition (HD) imaging–based assessment of wound healing at Day 15 compared to Baseline, documenting epithelialization and granulation tissue formation.
时间窗: Screening & Baseline (Day 0), | Follow-up (Day 7 ±2), | End of Study (Day 15 ±2)
次要结局
- hange in Subject Global Assessment (SGA) scores for redness, pus formation, swelling, pain, and itching from baseline to Day 7 and Day 15.
研究者
Dr Ranjitha S
RVS Ayurvedic Medical College Hospital and Research Centre