Evaluate the efficacy of Hirudotherapy in the management of non-healing ulcer with pre and post analysis of Leech saliva for its microbial load- A Randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hirudotherapy as add on treatment is effective in the management of Non-Healing Ulcer.
研究概览
简要总结
The present study title “Evaluate the efficacy of Hirudotherapy in the management of non-healing ulcer with pre and post analysis of Leech saliva for its microbial load- A Randomized control trial “ in the management of Dushta vrana will be conducted on 80 subjects with 40 in each group with mentioned objective and subjective parameters. one group will be treated with kaishora guggulu, aragwadadhi kashaya, jatyadi tail L/A, and other group with Jaloukawacharana with kaishora guggulu, aragwadadhi kashaya, jatyadi tail L/A. Assesment of leech saliva microbial load and patient will be done on 8, 16, 30th day.
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
- 17.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with normal CT, BT and Hb%.
- •Symptoms of chronic non-healing wound/ Dushtavrana (present for more than 4 weeks i.e. Dirghakalanubandi) with classical signs of Durgandha, vedhana, utsangi atipooyasrava, atigandha with Pooyasrava, Subjects with either sex and age between 18yr to 70 years, Yogya for jalokaavacharana according to classics, Subject who submits a written informed consent.
排除标准
- •Patients who have completed participation in any other clinical trial during the past six (06) months, Subjects with K/C/O bleeding disorders, Wound with excessive loss of tissue, Ayogya for Jalokaawacharan including Sarvangashopha, Pandu, Udara, Shosha, Subjects with H/O HIV I&II, HBsAg infections, severe anemia, or any other chronic illness (Like Diabetes, Hypertension, etc), Wound with other disorders e.g. Malignant ulcers, Syphilitic ulcers, Lepromatous ulcers, Tubercular ulcers, Severe Anemia, Burns.
结局指标
主要结局
Hirudotherapy as add on treatment is effective in the management of Non-Healing Ulcer.
时间窗: The frequency of Leech saliva will be collected before application, immediately after second vomitus and on 7th day.on this sample collect all data and compare .
Reduction in the microbial load (Pre and post application) of leech Saliva in Hirudotherapy.
时间窗: The frequency of Leech saliva will be collected before application, immediately after second vomitus and on 7th day.on this sample collect all data and compare .
次要结局
未报告次要终点
研究者
Dr Pawan Lalsangi
KAHERs Shri B M K Ayurveda Mahavidyalaya