Efficacy of an ayurvedic management protocol on the rate of recurrence, healing, and safety in Parikarthika (Fissure in Ano) -A Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- • Assessment of reduction in rate of recurrence of parikarthika i e the percentage of participant reported symptoms of fissure validated by physical examination, after the management with ayurveda protocol in comparison with diltiazem topical application.
研究概览
简要总结
Fissure in ano is one of the most common anorectal disease. Chance of recurrence of the condition is the most challenging issue in the management of the condition. The current study is a randomized controlled trial on the efficacy of an ayurvedic management protocol in parikarthika . The trial group management is by a standard conventional drug. sample size is 90 and the trial duration is 3 years . CCRAS is the sponsor and the study center is national ayurveda research institute for panchakarma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •Subjects of either sex with age between 18 and 60 years Subjects diagnosed of parikarthika with pain, bleeding per rectum and constipation.
- •Subjects, willing to give written informed consent to participate in the study.
排除标准
- •Subjects who are also suffering from, hemorrhoids, fistula in ano, peri anal abscess, fecal incontinence, and anal stenosis Acute fissure in ano, Secondary fissures, fissures located at lateral location and multiple fissures
- •Subjects with co-morbidity such as Diabetes Meletus, uncontrolled Hypertension, inflammatory bowel disease, Sexually transmitted diseases, Hepatitis B and C, tuberculous ulcer, clinically significant renal disease, hepatic disease, cardiovascular disease and psychological diseases Subjects on active drug abuse, alcoholics and on medication hampering wound healing.
- •Known sensitivity to any of the trial drugs or their ingredients Subjects who are already underwent operative treatment and under non operative treatments like botulinum inj or calcium channel blockers or topical nitrates.
- •Subjects who are currently undergoing either of the trial intervention within 30 days of randomization of the study.
- •Pregnant/lactating woman.
- •Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
• Assessment of reduction in rate of recurrence of parikarthika i e the percentage of participant reported symptoms of fissure validated by physical examination, after the management with ayurveda protocol in comparison with diltiazem topical application.
时间窗: 8th week 12th week and 112th week
次要结局
- • Assessment of treatment efficacy of management protocol evaluated using the REALISE score, by degree of healing (Re epithelialization) scoring system and by spasm of anal sphincters in comparison with diltiazem topical application(• Assessment of the safety of the Ayurveda management protocol regimen through reported incidence of adverse events ((Time frame: 14th day,28th day,56th day,84th day,112thday) and also laboratory safety parameters from baseline (CBC, LFT, KFT))
研究者
Dr Indu P P
National ayurveda research institute for panchakarma Cheruthuruthy