跳至主要内容
临床试验/CTRI/2024/08/071973
CTRI/2024/08/071973尚未招募2/3 期

Efficacy of single sitting Jalaukavacharana in Dushta Vrana (Diabetic Foot Ulcer) on selected inflammatory Bio-markers (TNF-ALFA, IL-6) -An open label clinical trial

KLE Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Elucidation of Atyayika Chikitsa Procedures in Inflammatory biomarkers concerned to Dushta Vrana(Diabetic Foot Ulcer)

研究概览

简要总结

Chronic wounds (diabetic foot ulcer) are one of the major concern in surgery from ancient times because of various factors are associated with the wound becoming non-healing. Acharya Sushruta has dedicated many chapters with dealing of chronic wounds, may be because he was well aware of treating the chronic wounds is troublesome. Incidence rate in India, the occurrence of chronic wounds is estimated at 4.5 per 1000 population1

Contemporary science has well described the pathophysiology and stages involved in the wound healing i.e. haemostasis, inflammation, proliferation, and remodeling2. The wound to become chronic, it means it has arrested in some step of wound healing. The recent articles have shown different inflammatory mediators have major role in delayed wound healing. In Diabetic foot ulcer TNF-𝛼 has shown prolonged expression as proinflammatory cytokine which has elevated or prolonged the inflammation in the wound3. Similarly IL-6 is the proinflammatory cytokine which was seen significantly high in diabetic patients with foot ulcer may be fundamental in the development of the ulcer4.

                    Jaloukavcharana is one of the method of blood letting mentioned in Ayurveda, Acharya Sushruta includes jalouka in anushastra (Accesory sharp instrument) and indicated in the symptoms like taapa, shotha , daha shows  pitta dosha pradhanta5 and as per studies they have  anticoagulant, analgesic, antiinflammatory, platelet inhibitory and thrombin regulatory functions as well as antimicrobial effects and extra cellular matrix degradative effects6. In a patient of diabetic foot there will be gross inflammation so we want see is there any effect of Jaloukavcharana in reducing in the proinflammatory cytokine (TNF-𝛼 and IL-6) in diabetic foot ulcers.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects fulfilling Diagnostic criteria of Dusta Vrana Subjects with Either sex between 18-60 years of age Yogya for jalaukavacharana Subjects with normal CT, BT and No clinical signs of Anaemia.
  • Controlled diabetes mellitus on medication (RBS < 140) Grading of diabetic foot ulcers of Grade 0 to 2 by Wagner-Meggitt Classification of Diabetic Foot included.

排除标准

  • Subjects with H/O Hypotension,during chemotherapy,active tuberculosis, HIV I&II, HbsAG infections, severe anaemia, haemophilia, thalasamia, other diseses affecting coagulant factors of blood or any other chronic illness and pregnancy.
  • Subjects with K/C/O bleeding disorders.
  • Grading of diabetic foot ulcers of Grade 3 to 5 by Wagner-Meggitt Classification of Diabetic Foot excluded.

结局指标

主要结局

Elucidation of Atyayika Chikitsa Procedures in Inflammatory biomarkers concerned to Dushta Vrana(Diabetic Foot Ulcer)

时间窗: Base line, 24hr, 7days

次要结局

未报告次要终点

研究者

发起方
KLE Ayurveda Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Jigneshkumar Varu

KAHER Shri B M K Ayurveda Mahavidyalaya and Medical research center Shahapur Belgavi

研究点 (1)

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