A comparative clinical study to evaluate the efficacy of Guggulu based Apamarga Ksharasutra and Snuhi Kshira based Apamarga Ksharasutra in Nadivrana with special reference to Pilonidal sinus.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Subjective Parameters
研究概览
简要总结
Pilonidal Sinus is a quite troublesome disease which poseschallenge to the surgeon by virtue of its recurrence. Ayurveda stresses the use of Ksharasutra inthe management of Nadivrana which occur in the region of Kutakasthi(Coccyx)which is obviously Pilonidal Sinus. The Surgeries like Z-Plasty which requireshospitalization and burdens a person with high costs. The Usage of Guggulubased Apamarga Ksharasutra or Snuhi Kshira based Apamarga Ksharasutra may be aneffective alternative. The present study with 30 patients of two groups treatedby two different standardized treatment modalities may yield results which canbenefit the mankind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having signs & symptoms of Nadivrana namely- pain, sero purulent discharge, presence of Nadi (track) in the natal cleft (Sacrococcygeal region) confirmed by probing.
- •2.Presence of even multiple sinuses on the either side of the midline.
排除标准
- •1.Sinus extending into the coccyx 2.Patients with evidence of malignancy 3.Patients with Diabetes Mellitus 4.Patients with Tuberculosis of spine, Osteomyelitis 5.History of HIV and other viral infections 6.Pregnant/ lactating women.
- •7.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •(Exclusion of the patients will be done after necessary investigations in the Pathological Laboratory of the Institution free of cost- Namely- Complete blood count, Random Blood Sugar, Fasting Blood Sugar, Post prandial Blood sugar, ESR, Urine for Sugar, Chest X Ray, HIV 1 and HIV 2.).
结局指标
主要结局
Change in Subjective Parameters
时间窗: 120 DAYS
Change of the Tenderness
时间窗: 120 DAYS
Change in length of the tract assessed by Probing, Sinogram and USG of sacrococcygeal region
时间窗: 120 DAYS
Photographs of the subjects on baseline, Subsequent visits for Change of Ksharasutra and on last visit while concealing his/her identity.
时间窗: 120 DAYS
次要结局
- Change in Subjective Parameters(Change of the Tenderness)