EVALUATION OF WOUND HEALING EFFECT OF OINTMENT CONTAI 5 PERCENT ESSENTIAL OIL FROM MAMMEA SURIGA BUCH HAM EX ROXB FLOWER BU TREATMENT OF DIABETIC FOOT ULCER A SINGLE ARMED OPEN LABEL CLINICAL STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of Ulcer mean surface areas by graph paper
研究概览
简要总结
Diabetic Foot Ulcers DFU chronic nonhealing ulcers generally encountered in clinical practice DFU has a major longterm impact on the quality of life of diabetics along with affecting their morbidity and mortality It is one of the major complications due to long standing Diabetes Mellitus with around 25 percentage of diabetics developing DFU during their lifetime Individuals with DFU are at a greater risk of premature death myocardial infarction and fatal stroke Treatment of DFU involves appropriate dressing antibiotics debridement and if required arterial revascularization Ensuring healing of DFU at their initial stages with proper debridement cleaning and dressing prevent them to reach to deeper tissues and avoid the possibility of amputation
Natural products particularly those synthesized from traditional medicine which have been explored since thousands of years are still in use directly or indirectly in the treatment of a range of diseases Mammea suriga flower buds an endemic tree species of Western Ghats with traditional importance are used in the traditional practices in the crude form for the management of cutaneous wounds It is rich in phytochemical constituents antioxidant anti-inflammatory and antimicrobial potentialities which helps in wound healing Hence the present investigation focused on wound healing efficacy of crude EO extracted from flower buds of Mammea suriga is under taken
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients of either sex in the age group of 20 to 60 years 2 Patient having DFU classified as per the university of Texas grade 1 and 2 with stage A and B size of 15 to 40 cm2 for a duration of more than one month 3 Patients who voluntarily provide written informed consent and were ready to follow procedures as per the study protocol 4 For DFU patients having either Type II DM with HbA1C of less than 8 with non-healing single or multiple ulcers neuropathic or mild neuro ischemic ulcer.
排除标准
- •1 Patients with ischemic ulcers Diagnosed Clinically or with Doppler 2 Known cases of severe chronic hepatic or renal disease 3 Known cases of any active malignancy 4 Having history of significant cardiovascular event less than12 weeks prior to recruitment chronic alcoholics or alcohol abuse 5 Patients ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia 6 Patient with history of tuberculosis contagious infectious disease such as Hepatitis B or C or HIV 7 Patients using any other investigational drug within 1 month prior to recruitment 8 Known hypersensitivity to any of the ingredients used in study drug 9 Pregnant and Lactating females.
结局指标
主要结局
Assessment of Ulcer mean surface areas by graph paper
时间窗: Baseline day15 day30 day45 day60
Assessment of ulcer healing process by Bates Jensen ulcer assessment tool Evaluation of ulcer healing process by clinical examination for evaluation of depth of ulcer undermining ulcer edges necrotic tissue type and amount type and amount of exudates appearance of skin colour around the ulcer peripheral tissue edema peripheral tissue induration granulation of ulcer epithelialization of ulcer will be done on every visit on graded scale on Bates Jensen ulcer assessment tool and will be compared with baseline
时间窗: Baseline day15 day30 day45 day60
次要结局
- Assessment of ulcer healing process by digital photographs
研究者
Dr Pradeep Shahjirao Shindhe
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi