The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia
      may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties,
      and may exacerbate symptomatology of co-morbid diseases. Current conventional treatment for
      insomnia includes both psychological and drug therapies. These conventional medications
      potentially may lead to dependency and withdrawal symptoms. Individualised homeopathic
      treatment is a process in which a homeopath selects the most appropriate remedy for the
      treatment of a condition in accordance with the fundamental principles of homeopathy. This
      treatment protocol may offer safe and effective treatment for insomnia disorder, however,
      more research is required on the subject. The aim of this study is to determine the effect of
      individualised homeopathic treatment of insomnia disorder in females using detailed case
      studies and the Insomnia Severity Index.
    

Detailed description: 
      This study will be of an embedded mixed method case study design, conducted at the University
      of Johannesburg Doornfontein Homeopathic Health Clinic over a period of 8 weeks. Ten female
      participants, aged 18 to 45 years, will be recruited by means of non-probability purposive
      sampling via advertisements placed in the University of Johannesburg Homeopathic Health
      Clinic and in pharmacies around Johannesburg, with the relevant permission given.

      The nature of the study, as well as the requirements for participation will be fully
      explained and the volunteers will be asked to sign the Participant Information and Consent
      Form once they agree to participate. Potential participants will undergo a brief screening to
      determine if they meet the requirements for this study. The participants that meet the
      inclusion criteria will attend the initial consultation and those that do not meet the
      inclusion criteria will be referred to the Homeopathic Health Clinic.

      The consultation will consist of a comprehensive homeopathic case history, the conduction of
      relevant physical exams, including vital signs, and the completion of the Insomnia Severity
      Index (ISI). The participant's case will be analysed and computer repertorised, using the
      Complete Repertory of Mercurius homeopathic software (Aeon Group), version 5.3.0.17. The
      individualised homeopathic remedy will be selected by the researcher who will refer to the
      appropriate Materia Medica. The Homeopathic Dispenser will dispense the homeopathic remedy to
      the participant.

      Each participant will return for four follow-up consultations which will be two weeks apart.
      At each follow-up consultation the ISI will be completed and a follow-up case history and
      physical examination of the participants' vital signs will be conducted. The participants'
      symptoms will be re-evaluated and a remedy prescribed accordingly. At the final consultation
      in the 8th week, no remedy will be prescribed.

      Data will be collected and analysed by the researcher with the assistance of a statistician
      at Statkon, using non-parametric tests, including: frequencies and descriptives, the Friedman
      test, and Wilcoxon post hoc test.

      The possible outcome of this study may demonstrate that individualised homeopathic treatment
      is effective in reducing the frequency and intensity of insomnia disorder in females, and
      instigate further research on the subject.
    

Intervention name(s): Individualised Homeopathic Remedy
Intervention type(s): Other
Intervention description(s): Sucrose pillules will be medicated with the individualised homeopathic remedy as determined by the researcher, in the potency, dosage and repetition determined by the researcher in accordance with the laws governing homeopathic prescribing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Females; Homeopathy