The Efficacy of Individualised Homeopathic Treatment on Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

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 description: 
      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.

      At each follow up consultation, the participant's case will be re-evaluated with special
      attention made to changes in symptoms or the appearance of new symptoms, the details of which
      will be recorded on the Case Follow Up Form, as designed by the researcher. A remedy will be
      prescribed in the same manner as the initial consultation. The prescription may be repeated
      or altered in accordance with the participant's presenting symptoms and response to the
      previous prescription. The laws that govern individualised homeopathic prescribing will be
      used at all times in determining a prescription.

      The qualitative data collected from the case taking forms, will be used by the researcher to
      write detailed case studies. The quantitative data collected, using the Bowel Function Diary
      and Bristol Stool Form Scale, will be used to assess the participants' changes in defecation
      quality and frequency over the course of treatment, the results of which will be represented
      graphically.

      This study will contribute to the body of knowledge of the homeopathic treatment of
      constipation and may provide a foundation for further research on the efficacy of
      individualised homeopathic treatment of constipation.
    

Intervention name(s): Individualised Homeopathic Remedy; 20% ethanol
Intervention type(s): Other; Drug
Intervention description(s): 20% ethanol will be medicated with the Individualised Homeopathic Remedy in the potency determined by the researcher in accordance with the laws that govern individualised homeopathic prescribing. The medicated 20% ethanol will be administered as drops.
Other intervention name(s): Similimum
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation; Homeopathy