Clinical Trial: The Efficacy of Individualised Homeopathic Treatment on Constipation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy of Individualised Homeopathic Treatment on Constipation

Brief Summary:

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.

Detailed Summary:

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 Func
Sponsor: University of Johannesburg

Current Primary Outcome: Bowel Function Diary (Adapted) [ Time Frame: 6 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Bristol Stool Form Scale [ Time Frame: 6 Weeks ]
  The Bristol Stool Form Scale is a 7 score visual scale to measure stool consistency. It has been proved to be a reliable and valid measure, and can be effectively used with participants over the age of 8 for research purposes.
• Means of case notes, recorded on homeopathic Case Taking Form [ Time Frame: Every 2 weeks for 6 weeks ]
  Qualitative data will be collected by means of case notes, recorded on homeopathic Case Taking Forms, which will be taken at weeks 0, 2, 4 and 6.

Original Secondary Outcome: Same as current

Information By: University of Johannesburg

Dates:
Date Received: April 3, 2015
Date Started: October 2014
Date Completion:
Last Updated: May 18, 2016
Last Verified: May 2016