Clinical Evaluation of Ashwagandhadi Lepa in Parikartika (Fissure-In-Ano)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Relief in pain and burning sensation during defecation.
研究概览
简要总结
An anal fissure is a longitudinal ulcer in the anoderm of the distal anal canal, which extends from the anal verge proximally towards, but not beyond, the dentate line. The most common site for occurrence of an Anal fissure is the midline posterior (90%). The next most frequent situation is the midline anteriorly. In males fissure usually occurs in the midline posteriorly (90%) and much less common anteriorly (10%). In females, fissure on the midline posterior is common than anterior (60:40). The relative frequency of the anterior fissures in the females may be explained by the trauma caused by the fetal head on the anterior wall of the anal canal during delivery. An Anal fissure is either - Acute or Chronic. Constipation has been the most common etiological factor. In Fissure-in-Ano, there is a trauma to the lower anal canal caused by the movement of hard scybalous stool. Pain will be so severe that patient may avoid defecation for days, thus leading to worsening of the condition.
This study is an interventional , open label, single group trial, CLINICAL EVALUATION OF ASHWAGANDHADI LEPA IN PARIKARTIKA (FISSURE-IN-ANO). The case will be selected randomly from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar (U.K.) India. The study will be intervened under one group with local application of Ashwagandhadi Lepa, for twice a day till complete healing. Assessment criteria will be done on subjective and objective parameters. For follow up the patients will be asked to come to the OPD of Shalya tantra Department for 1 month at 15 days interval.
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
- 16.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who have classical symptoms of Parikartika (Fissure-In-Ano).
- •Patients of age group between 16-70 years of age.
- •Patients of either sex will be selected.
排除标准
- •Patients below 16 years and above 70 years of age.
- •Patients with uncontrolled DM and HTN.
- •Known cases of Malignancy, Ulcerative colitis, Crohn’s disease, Syphilis and Tuberculosis.
- •HBsAg, VDRL, HCV and HIV positive patients.
结局指标
主要结局
Relief in pain and burning sensation during defecation.
时间窗: Weekly interval up to 21 days.
Relief in itching in anal region and constipation.
时间窗: Weekly interval up to 21 days.
次要结局
- Healing of ulcer and relieving of sphincter spasm. Relief from bleeding during defecation.(Weekly interval upto 21 days.)
研究者
Dr Vishal Verma
Rishikul Campus, Haridwar.
