A Single Arm Clinical Study To Evaluate The Role Of Jalaukavacharan For Kandu And Daha In Vranagranthi (Keloid).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To study the effect of leech application in keloid
研究概览
简要总结
Title- A SINGLE ARM CLINICAL STUDY TO EVALUATE THE ROLE OF JALAUKAVACHARAN FOR KANDU AND DAHA IN VRANAGRANTHI (KELOID).
Null Hypothesis : H0 Jalaukavacharan is not effective in vranagranthi(keloid).
Alternative Hypothesis : H1 Jalaukavacharan is effective in vranagranthi(keloid).
Study design -Single arm open label clinical trial
Inclusion Criteria:
1)Patient of vranagranthi with daha and kandu
2)Age group 18-60years.
3)Patients with written consent.
4)vranagranthi from all over the body except face
- Patient indicated with jalaukavacharan
6)Patients with familial pedigree for developing vranagranthi
[2] Exclusion Criteria:
- vrana granthi over vital areas.
2)Patient with uncontrolled Diabetes mellitus and hypertention.
3)Patient with bleeding disorder
4)Pregnancy
5)Patient with long term use of systemic corticosteroid , systemic chemotherapy or immunosuppresive drugs.
6)Patient with allergy to leeches.
7)Patient on anticoagulant medication.
Sample size- Total 30
Diagnosed patients of vranagranthi from OPD and IPD of Ayurvedic rugnalaya and camps in the periphery of parent rugnalaya and research center will be taken as sample.
Study group-Jalaukavacharan
Total duration of drug administration will be 21 days.The mode of drug administration will be by local route.
Follow up - follow up will be on 7th, 14th, 21st, 28th day.
Result- Result will be drawn as per assesment criteria & statistical analysis
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
- •1.Patient of vranagranthi with daha and kandu 2.Age group 18-60years.
- •3.Patients with written consent.
- •4.vranagranthi from all over the body except face 5.Patient indicated with jalaukavacharan 6.Patients with familial pedigree for developing vranagranthi.
排除标准
- •1.vrana granthi over vital areas.
- •2.Patient with uncontrolled Diabetes mellitus and hypertention.
- •3.Patient with bleeding disorder 4.Pregnancy 5.Patient with long term use of systemic corticosteroid , systemic chemotherapy or immunosuppresive drugs.
- •6.Patient with allergy to leeches.
- •7.Patient on anticoagulant medication.
结局指标
主要结局
To study the effect of leech application in keloid
时间窗: 21 days study with follow up on 7th,14th,21st and 28th day
次要结局
- 1. To establish jalaukavacharan as an effective treatment modality in vranagranthi .(2. Literature review of vranagranthi from ayurvedic text.)
研究者
Dr Pragati Krushnarao Ghuse
MES Ayurved Mahavidyalaya