A double-blind, randomized, study on the efficacy of individualized Homoeopathic medicines in treating Hemorrhoids- a placebo controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Parameters for outcome assessment will be done in Ano-Rectal Symptom Severity and Quality of Life (ARSSQoL) questionnaire with English, Bengali or Hindi version. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being of patients suffering from hemorrhoids.
研究概览
简要总结
Haemorrhoids are cushions of submucosal vascular tissue located in the anal canal starting just proximal to the dentate line. These vascular cushions are a normal anatomical structure of the anal canal, and their existence does not necessarily indicate haemorrhoidal disease. Haemorrhoids may be classified into internal haemorrhoids, originating from the internal haemorrhoidal plexus above the dentate line, and external haemorrhoids, originating from the external haemorrhoidal plexus below the dentate line.
There is quite lack of data available in homoeopathy in treatment of hemorrhoid. keeping in view this lack of validated clinical trial on hemorrhoid, we aimed to evaluate effects of homoeopathic medicines beyond placebo by conducting this double- blind, placebo controlled trial of individualised homoeopathic medicines against placebo at The Calcutta Homoeopathic Medical College & Hospital on 114 participants with hemorrhoids.
Parameters for outcome assessment in English, Bengali and Hindi version of the ARSSQoL questionnaire. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being patients suffering from haemorrhoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •i) Age 18-65 years ii) First degree (grade I) haemorrhoids without prolapse outside of anal canal iii) Second degree (grade II) haemorrhoids that prolapse with straining, but retract spontaneously iv) With any of the following clinical symptoms: bleeding, pain (including discomfort and tenesmus during defecation or any other time), heaviness, pruritus, and mucus discharge.
- •v) Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires vi) Literate patients; ability to read Bengali and/or English and/or Hindi vii) Patients giving written consent to participate.
排除标准
- •i) Pregnant or lactating women ii) Forth degree (grade IV) haemorrhoids iii) External haemorrhoids iv) Skin tags v) Malignancies vi) Rectal polyps vii) Anal fissure viii) Irritable bowel syndrome ix) Unstable mental or psychiatric illness or other systemic diseases (e.g., uncontrolled hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ failure.
- •x) Any substance abuses xi) Self-reported immune – compromised state xii) Patients who are too sick for consultation xiii) Simultaneous participation of any other clinical trials.
- •xiv) Undergoing homoeopathic treatment for any chronic disease within last 6 month.
结局指标
主要结局
Parameters for outcome assessment will be done in Ano-Rectal Symptom Severity and Quality of Life (ARSSQoL) questionnaire with English, Bengali or Hindi version. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being of patients suffering from hemorrhoids.
时间窗: 2 years or till targeted sample size achieved
次要结局
- To document occurrences of adverse events & Homoeopathic aggravations in all the groups during the trail phase & to shortlist the most frequently indicated Homoeopathic medicines with their indications.(3 months of trial phase)
研究者
Dr. Anjan Roy
The Calcutta Homoeopathic Medical College and Hospital