Efficacy of homoeopathic medicines in the treatment of primary chronic anal fissures: A multicentric, double-blinded, randomized placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- REALISE score
研究概览
简要总结
Chronic anal fissure (CAF) is defined as an ulcer that lasts at least six weeks due to chronic hypertonia of the anal sphincters and gets inflamed with scar tissue. Diagnosis is usually made from history and clinical presentation of pain could be a dominant symptom which is very intense in acute fissures but less severe in chronic cases. Often, they are associated with constipation, bleeding and mucous discharge from the anus. The recommended gold standard treatment modality for chronic fissures is lateral internal sphincterotomy (LIS) which often leads to complaints associated with stool continence. Alternatively, Chemical sphincterotomy (CS) with botulinum toxin, nitrates or calcium blockers is also recommended as non-invasive methods but the efficacy of such interventions are not well established. In homoeopathy, no good quality studies have been conducted on this condition to date, therefore this current trial is aimed to find whether empirically used medicines alter the outcome of treatment of chronic primary anal fissure. Homoeopathic medicines are clinically found to be safe and effective for the condition and the same evidence is to be confirmed within this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients suffering from clinically diagnosed chronic anal fissures presented with a minimum pain REALISE score of 10
- •Patients with longitudinal anal fissures
- •Age- 18 to 75 years
- •Both sexes
- •Persons suffering from chronic disorders like diabetes mellitus, hypertension, hypercholesteremia, metabolic syndrome, rheumatological disorders, joint disorders, and hypothyroidism are in a stable state elicited by a stable dosage of medicines for such conditions for the last three months.
- •Voluntary informed consent.
排除标准
- •Patients with lateral anal fissures with or without rectal or anal carcinoma
- •Patients underwent lateral sphincterotomy or hemorrhoidectomy, or any anal or rectal surgery
- •Patients with self-reported chronic diseases like Tuberculosis, sexually transmitted diseases, HIV-AIDS, and other immune-compromised states.
- •Patients reportedly practicing anal coitus
- •Patients with diagnosed severe psychological disorders like bipolar disorders, Schizophrenia, suicidal disorders, opioid abuse, and severe mania.
结局指标
主要结局
REALISE score
时间窗: REALISE score at baseline, 3 months, 6 months, 9 months and 12 months
次要结局
- Recurrence of anal fissure(At any point from baseline till end of follow up)
- Occurence of anal incontinence to hard or soft stool(Any point from baseline to end of follow-up)
- Requirement of anal dilatation under local anesthesia or pain relieving medicines(Any point from baseline to end of follow-up)
- Drop out of participants in the study groups(Any point from baseline till end of follow-up)
研究者
Dr Baidurjya Bhattacharjee
Regional Research Institute for Homoeopathy, Siliguri
