A comparative clinical study to evaluate the efficacy of manjistadi ghrita gudavarthi and manjistadi ghrita in the management of parikarthika vis-a-vis acute fissure in ano
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Fissure in ano is a longitudinal tear in the lower part of the anal canal extending from just below the dentate line to the anal verge. Initially, it involves only the epithelial layer but may later extend deeper into the anal mucosa. It commonly occurs in the posterior midline of the anal canal and is usually caused by trauma due to the passage of hard stools, followed by secondary infection. Spasm of the anal sphincter leads to severe pain during and after defecation.
The condition commonly affects young and middle-aged individuals, with a mean age of around 39.9 years. About 75% of fissures occur in the posterior midline, while 25% occur anteriorly, which is more common in women. Nearly 40% of acute fissures may progress to chronic fissures. The annual incidence is approximately 0.11%, with variations according to age and sex.
Modern treatments such as topical medications, botulinum toxin injections, and lateral sphincterotomy are available but have several limitations, including headache, recurrence, sphincter weakness, infection, and risk of fecal incontinence.
In Ayurveda, fissure in ano is correlated with Parikarthika, characterized by severe cutting pain in the anal region. Acharya Sushruta has recommended Manjistadi Ghrita for Vrana Shodhana and Vrana Ropana (wound cleansing and healing). In this study, Manjistadi Ghrita Guda Varti, prepared using Maduchhista (beeswax) as the base, is used to provide prolonged contact of the medicine with the affected area. Due to its Vrana Ropana, Vata-Pitta Shamana properties, a clinical comparative study was conducted to evaluate the effectiveness of Manjistadi Ghrita Guda Varti and Manjistadi Ghrita in the management of Parikarthika (fissure in ano).
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically diagnosed cases of fissure in ano are taken for study.
- •2.Patients having acute fissure in ano with duration less than 12 weeks.
- •3.Patients, irrespective of religion, occupation and economic status are taken.
- •4.Patients of both sexes, between age group of 18 to 60 yrs.
排除标准
- •1.Patients having fissures in ano secondary to ulcerative colitis, syphilis, Crohns disease, tuberculosis.
- •2.Patients suffering from malignancy of any organ or ano rectum are excluded.
- •3.Patients suffering from chronic fissures and sentinel tags.
- •4.Patients with uncontrolled diabetes.
- •5.Patients suffering from fissure in ano are associated with conditions like hemorrhoids and fistula in ano.
- •6.Patients with infectious diseases like HbsAg and HIV.
研究者
DR HARITHA B
Muniyal institute of ayurveda medical sciences, Manipal