The Efficacy of Individualised Homeopathic Treatment on Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Bowel Function Diary (Adapted)
研究概览
简要总结
Constipation is an umbrella term encompassing either infrequent bowel movements, difficult evacuation of stool, hard stool or a sensation of incomplete defecation. It affects 10-15% of the global population. Constipation may negatively impact physical health, moods and social life. There exists a 50% dissatisfaction with traditional approach of laxative use. Conventional laxatives only offer a temporary solution and may cause dependency. Side-effects of conventional laxatives include nausea, vomiting, flatulence, diarrhoea, abdominal pain, electrolyte imbalance and skin eruptions. Homeopathy is a potential treatment option for constipation, however further research is needed in this regard.
The aim of this study is to determine the efficacy of individualised homeopathic treatment on constipation using case studies, an adapted Bowel Function Diary and the Bristol Stool Form Scale.
详细描述
The research study will be of an embedded mixed method case study design and take place over a 6 week period at the University of Johannesburg Doornfontein Health Centre. Ten participants of either gender, between the ages of 18 to 50 years will be recruited using advertisements placed at the Doornfontein campus Health Centre.Those interested in participating in the research will be requested to attend an initial meeting in which they will receive a Participant Information Form and be requested to sign a Consent Form.
Participants meeting the inclusion criteria will be recruited into the study and a Selection Questionnaire confirming their constipation status will be completed with the help of the researcher. The researcher will then perform a full case taking and relevant physical examination of the participant, the details of which will be recorded on a homeopathic Case Taking Form, as designed by the researcher. The characteristic details of the case will then be identified and analysed using using the Mercurius software Repertory. The homeopathic Materia Medica will be referred to in order to confirm the remedy which best suits the presenting symptomology of the participant. The repertorisation and remedy selection will be conducted under the supervision of a qualified homeopath.
The potency, dose and frequency of the selected remedy will be determined according to the laws that govern individualised homeopathic prescribing.
The remedy will be administered along with an explanation and demonstration on how to take the remedy. A set of written instructions will be provided for the participant in the form of a Patient Information Leaflet.
The participant will be requested to monitor each defecation session and a Bowel Function Diary will be used to record the frequency of defecation, the stool form and the level of difficulty on passing a stool. Participants will return for three follow up consultations at 2 week intervals. If dramatic changes occur in the participant, they will be requested to contact the researcher, who will adjust the treatment accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between ages 18-50 years,
- •meet the Rome II criteria for constipation which lists:
- •have a bowel evacuation for 3 or less times in a week, for the last 3 months OR
- •have to strain, have hardened stool, or have incomplete bowel evacuation for at least 25% of the time, for the last 3 months.
排除标准
- •People currently on treatment for their constipation,
- •who have used laxatives more than three times in the past month,
- •are on medications which have constipation as a side effect,
- •with pre-diagnosed colon cancer, irritable bowel syndrome- constipation dominant, spastic colon or diverticulitis, and those who had a stroke, and,
- •pregnant females.
研究组 & 干预措施
20% Ethanol
20% ethanol will be medicated with the individualised homeopathic remedy as determined by the researcher and administered as drops. The potency, dose and frequency of the medicated 20% ethanol drops will be determined for each prescription, in accordance with the laws that govern homeopathic prescribing.
干预措施: Individualised Homeopathic Remedy (Other)
20% Ethanol
20% ethanol will be medicated with the individualised homeopathic remedy as determined by the researcher and administered as drops. The potency, dose and frequency of the medicated 20% ethanol drops will be determined for each prescription, in accordance with the laws that govern homeopathic prescribing.
干预措施: 20% ethanol (Drug)
结局指标
主要结局
Bowel Function Diary (Adapted)
时间窗: 6 Weeks
The Bowel Function Diary is a is a daily record of factors relating to defecation. For this study only two of its items will be monitored- the number of bowel movements and the associated ease or difficulty of defecation. The diary has been demonstrated to have an acceptable test-retest reliability and supported validity for each item, with a p-value of \<0.001.
次要结局
- Bristol Stool Form Scale(6 Weeks)
- Means of case notes, recorded on homeopathic Case Taking Form(Every 2 weeks for 6 weeks)
研究者
Dr J. Pellow
Dr J. Pellow
University of Johannesburg