The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females

Insomnia Disorder Clinical Trial

Official title: The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT02409264
• Study type: Interventional
• Source: University of Johannesburg
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Completion date: August 2015