Double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving symptoms of chronic anal fissure in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- The scoring system for anal fissure (REALISE)
研究概览
简要总结
An anal fissure (AF) is a small break or tear in the skin of the anal canal, which typically runs from below the dentate line to the anal verge, and is usually situated in the posterior midline. AF is a small break or tear in the skin of the anal canal, which typically runs from below the dentate line to the anal verge, and is usually situated in the posterior midline. Anal fissure is one of the most frequent and painful anal disease. It is very painful, because it affects the multilayer squamous epithelium of the anoderm, which is richly innervated by pain fibers. During defecation, the lesion is stretched with consequent painful symptomatology, which can persist for a certain amount of time and be accompanied by slight bleeding. The pain can be so intense as to induce the patient to avoid defecation with consequent hardening of the stool and exacerbation of the problem. Anal fissures are not common in patients older than 65 years, and this age group must be suspected to be associated with other pathologies. The lifetime incidence is calculated to be 11%.Homeopathy may have immense potential to offer in successful treatment in chronic anal fissure, but has remained seriously under-researched till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of chronic anal fissure in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 111 adults who are suffering from chronic anal fissure at the outpatient department of D N De Homoeopathic Medical College and Hospital. Assessment will be done by the scoring system for anal fissure (REALISE) [Primary outcome], Anorectal symptom severity and quality of questionnaire (ARQSSoL), and Measure yourself and medical outcome profile (MYMOP-2) [Secondary outcomes], all to be measured every 15 days, up to 3 months. Comparative analysis will be carried out to detect group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cases suffering from chronic anal fissure ICD-10(K60.1), with symptoms persisting for more than 6 weeks.
- •Participants of either sex or transgender.
- •Age between 18 and 65 years.
- •Literate patient; ability to read and write in Bengali and/or English.
- •Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires
- •Patients with known but controlled systemic diseases.
- •Patients using topical agents for anal fissure will be included after a washout period of one week, subject to persistence of symptoms and signs of fissures.
- •Patients giving written consent voluntarily to participate.
排除标准
- •1.Cases suffering from uncontrolled systemic illness or life-threatening infections.
- •Cases already undergoing homoeopathic treatment elsewhere for any chronic purpose within last 6 months.
- •Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •Previous history of surgical interventions for anal fissure.
- •Diagnosed or suspected cases of rectal malignancies.
- •Pregnancy, puerperium and lactation.
- •Secondary fissure.
- •Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •Simultaneous participation of any other clinical trial.
结局指标
主要结局
The scoring system for anal fissure (REALISE)
时间窗: At baseline, every 15 days, up to 3 months
次要结局
- Anorectal symptom severity and quality of life questionnaire (ARSSQoL)(Measure yourself medical outcome proile (MYMOP-2))