Randomized Comparative Clinical Evaluation of Classical Regimen Irsal-i-‘Alaq (Hirudotherapy) versus Platelet-Rich Plasma Therapy in Qurooh-e-Muzmina (Chronic Ulcers)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
研究概览
简要总结
This randomized, open-label, comparative Phase II clinical trial aims to evaluate the effectiveness of the classical Unani regimen Irsal-i-Alaq (Hirudotherapy**)** in comparison with Platelet Rich Plasma (PRP) therapy in the management of Qurooh-e-Muzmina (chronic****ulcers)
Chronic ulcers are wounds that fail to heal within six weeks due to factors such as impaired circulation infection or systemic diseases like diabetes In this study 50 patients aged from18 years with Wagner grade II–V chronic ulcerswill be randomly allocated into two groups Group A receiving leech therapy and Group B receiving PRP therapy once weekly for 8 weeks
Outcomes will be assessed through clinical parameters including wound size reduction wound healing rate pain score (VAS) granulation tissue formation and quality of life measures
The study aims to compare the clinical outcomes of both therapies and evaluate the therapeutic potential of hirudotherapy as a safe and effective treatment option for chronic non-healing ulcers
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of chronic ulcers All adult patients from the age of 18yrs Both genders Patients having ulcers of grade II to V as per Wagner classification HbA1C is less than 7 (controlled diabetes).
排除标准
- •Pregnant and lactating women Patients having psychological disorders Immunocompromised patients Patients on anticoagulant or antiplatelet therapy (aspirin warfarin clopidogrel etc) Patients of bleeding disorders and Severe anemia (Hb less than 8 g per dL) and hypotension Platelet dysfunction or platelet count less than 150000 per µL (for PRP group) Known hypersensitivity to leech saliva or its components (for Leech group) Patients who refuse to sign the consent.
研究者
Mohammad Areeb
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital