A Randomized Comparative Clinical Study to Evaluate The Efficacy of Vranadhoopan And Hyperbaric Oxygen Therapy In The Management of Diabetic Foot Ulcer
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Objective criteria Bates Jensen Wound Assessment Tool Subjective Criteria VRS (Verbal Rating Scale) for Pain Burning sensation and Itching Sensation
研究概览
简要总结
The synopsis titled “A Randomized Comparative Clinical Study to Evaluate the Efficacy of Vranadhoopan and Hyperbaric Oxygen Therapy in the Management of Diabetic Foot Ulcer” aims to scientifically assess two distinct therapeutic approaches—an Ayurvedic fumigation method (Vranadhoopan) and a modern oxygen-based therapy (HBOT)—in treating diabetic foot ulcers.
Diabetic foot ulcer is a major complication of diabetes, often leading to infection, amputation, and disability. Ayurveda correlates it with Pramehaj Vrana, described as a chronic non-healing wound caused by vitiated doshas. The study integrates the Ayurvedic concept of Vranadhoopan—fumigating wounds with herbal smoke (Nirgundyadi Dhoopa containing Nirgundi, Nimba, Hartala, Sarshapa, etc.)—which possesses antimicrobial, anti-inflammatory, and wound-healing properties. In comparison, Hyperbaric Oxygen Therapy (HBOT) enhances tissue oxygenation, angiogenesis, and collagen synthesis, promoting faster healing.
The study is designed as a randomized comparative clinical trial on 32 patients diagnosed with diabetic foot ulcers, divided equally into two groups—Group A (Vranadhoopan) and Group B (HBOT). Treatment will be administered daily for 15 days, followed by a one-month follow-up. Assessment will be done using the Bates-Jensen Wound Assessment Tool, evaluating parameters like pain, burning, itching, exudate, granulation, and epithelization.
The research seeks to determine the relative efficacy, safety, and cost-effectiveness of both therapies. Expected outcomes include faster wound healing, enhanced granulation and epithelialization, and reduced infection risk. This integrative approach aims to validate Ayurvedic wound management scientifically and offer a cost-effective alternative for diabetic foot ulcer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Group-Patients between 18 to 70 years with clinically diagnosed Diabetic Foot Ulcer.
- •Type of Ulcer Presence of chronic, non-healing Diabetic Foot Ulcer for at least 2 Weeks.
- •Size of the wound greater than 4 sq cm to less than 10sq cm.
- •Wound Classification-Wagner classification Grade 1 to 3 ulcers (no gangrene).
- •Blood Sugar Levels- HbA1c less than 7 percent.
- •Irrespective of age gender Religion Occupation and economic status.
排除标准
- •Age Below 18 and Above
- •Size of wound less than 4 sq cm and greater than 10 sq cm.
- •Severe Ulcers, Wagner’s Grade 4 and 5 ulcers (gangrene or extensive necrosis).
- •Uncontrolled Diabetes HbA1c greater than 7 percent.
- •Patients with wounds other than Diabetic wounds.
- •Any comorbid condition except diabetes.
- •Pregnant lady & lactating women.
- •Diagnosed cases of HIV and HbsAg.
结局指标
主要结局
Objective criteria Bates Jensen Wound Assessment Tool Subjective Criteria VRS (Verbal Rating Scale) for Pain Burning sensation and Itching Sensation
时间窗: Duration 15 Days or up to healing | Whichever is less Follow up Up to 1 month every 7 days
次要结局
未报告次要终点
研究者
Dr Jignesh Babubharthi Goswami
G. J. Patel Institute of Ayurvedic Studies And Research