Usefulness of Paeonia Officinalis Q in the management of acute anal fissure: An open-label, prospective, non-randomised, observational study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS for Pain
研究概览
简要总结
Anal fissure (AF), as a prevalent cause of excruciating anal pain, is one of the most common anorectal problems observed in clinical practice. Nowadays, a lot offolks who have this condition use alternative therapies. The efficacy of homoeopathic remedies for AF is asserted, however reports often include other ano-rectal problems. The proposed study will look at the usefulness of Paeonia Officinalis Q, a homeopathic medicine in the management of anal fissures. This will be a prospective, open-label, non-randomized, observational, single-center pre-post comparison design study that shall be carried out at the homeopathic outpatient department (OPD), AIIMS Bhopal, and the sample size will be 40 (after calculation). Administration of Paeonia Officinalis is planned orally in mother tincture (Q) form. It will be given 10 drops mixed with a half cup of water once a day (OD) orally as per standard guidelines mentioned in Homoeopathic Pharmacopoeia of India (HPI) and the duration of such treatment will be of 3 months. The study objectives are; to assess the efficacy Paeonia Officinalis Q for pain and healing of fissure (HoF) and safety chiefly. The outcome parameters are VAS for pain, healing of fissure, Defecation strain score (DSS), and ORIDL scale will be measured at different times during the study period. The analysis shall be carried out with per protocol approach. Data distribution shall be examined by Shapiro Wilk test for normality. The baseline descriptive data (categorical and continuous) will be presented in terms of absolute values and percentages, means and standard deviations. Parametric or non-parametric inferential test will be planned as per the normality of data distribution comparing dependent observations of continuous outcomes at baseline and after 3 months of intervention. P values less than 0.05 will be considered as significant. SPSS®-IBM® v. 20 for windows will be used for analysis of data. This study may open new avenues for the management of AF as a non-surgical, cost-effective, alternative therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects must be 18 years and above with moderate health.
- •Subjects with 4 weeks (28 days) or less history of painful acute anal fissure (AF), prior to screening, where AF-related pain-associated with, or following, defecation is experienced at least twice a week during the symptomatic phase.
- •3.Subjects with an average of equal or more than of 4 on a 10-point VAS scale during the screening phase for worst anal pain associated with, or following, defecation for the most recent 3 days on which the subject has defecated.
- •Subjects with evidence of a radial fissure; seen on anal examination.
- •5.Subjects who are not taking any other concomitant oral/topical preparations applied perianally prior to commencing study treatment, and throughout the study.
- •Able to give consent.
排除标准
- •ï‚· Subjects, who are unwilling to be examined for AF.
- •ï‚· Subjects have undergone a sphincterotomy or anal stretch or other previous interventions involving the anal canal or perianal region ï‚· Subjects having multiple fissures will be excluded.
- •ï‚· Who have had sub-fissure injection of botulinum toxin within 6 months period or used glyceryltrinitrate (GTN) ointment for > 1 week in the 4 weeks prior to the screening visit ï‚· Severely immuno-compromised patients for example patients with history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency, treatment with oral or intravenous steroids.
- •ï‚· Have cardiovascular disease, fixed anal stenosis/fibrosis or severe haematological illness like Sickle cell disease.
- •ï‚· Pregnant women.
结局指标
主要结局
VAS for Pain
时间窗: Baseline, 2, 4, 8 and 12 weeks.
次要结局
- Healing of Fissure(4, 8 and 12 weeks)
- Defecation Strain Score(Baseline, 2, 4, 8 and 12 weeks.)
- ORIDL score(2, 4, 8 and 12 weeks)