Uility of Individualized Homoeopathic Medicine in 50-millesimal potencies in themanagement of Anal Fissure: A Pretest-Posttest Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Numerical pain rating scale (0-10).
研究概览
简要总结
Anal fissure is one of the most prevalent anorectal illnesses; it is caused by a longitudinal tear in the anoderm beneath the dentate line. Defecation is painful, and there is constant bleeding. The majority of fissures are treated conservatively, however a significant percentage become chronic and have a detrimental effect on the patient’s general quality of life. Among the complementary and alternative medicine (CAM), Homoeopathy is one of the non-invasive therapeutic option for the management of ano-rectal disorders. Homoeopathy have the evidences in favour of anorectal disorders. In homoeopathic perspective, the treatment of patient is mainly based on individualization. All the patients have to enquire as a whole. Homoeopathy not only manages fissures, it also prevents relapses. Homoeopathic literatures are lacking the evidences in anal fissures; it has not been researched systematically. Even there are no studies using 50 millesimal potencies in the managing anal fissures. Fifty millesimal potencies having some evidences in treating acute or chronic diseases in its favour.Therefore the investigator aims to evaluate the utility of individualized homoeopathic medicine in 50-millesimal potencies in the management of anal fissure. The medicine are will be administered orally, and it is safe for use in humans. All the medicines will be prescribed in 50-millesimal potencies.Doses and repetition will be as per homoeopathic principles. The outcomes will be Numerical pain rating scale (0-10), HEMO-FISS score, will be measured at baseline ans after 3 months of treatment. the likelihood of improvement will be assessed by Modified Naranjo Criteria for Homoeopathy (MONARCH) score.
Duration of therapy: 3 months for each individual case.
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 65.00 Year(s)（—）
入选标准
- •65 years. ii.Gender: Both Male and Female. iii.Diagnosed cases of Anal Fissure iv.Patients using topical agents for fissure will be included after a washout period of two weeks, subject to persistence of symptoms and signs of fissures v.Patient voluntarily giving written informed consent for the study.
排除标准
- •i.Severe co-morbidities or any other uncontrolled systemic diseases, life-threatening illness etc.
- •affecting Quality of Life.
- •ii.Pregnant or breast-feeding women.
- •iii.Substance abuse and/ or dependence.
- •iv.Psychologically unstable patients.
- •v.Previous history of surgical interventions for anal fissure.
- •vi.Diagnosed or any suspected cases of rectal malignancies vii.Under-going homoeopathic treatment for any chronic diseases for last 3 months.
- •viii.Patients who are unable to read the patient information sheet and written consent form.
- •ix.Patient unwilling to take part in the study and not giving written consent for this study.
结局指标
主要结局
Numerical pain rating scale (0-10).
时间窗: Baseline and after 3 months.
次要结局
- HEMO-FISS scale(Baseline and after 3 months.)
- Modified Naranjo Criteria for Homoeopathy (MONARCH)(After 3 months of treatment)