An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Premenstrual Syndrome (PMS) is a group of physical, mental and behavioural symptoms that
      occur cyclically through the luteal phase of the menstrual cycle and resolve within three
      days of the onset of menstruation. Many women are affected by the physical and psychological
      symptoms of PMS. The symptoms of PMS can change behaviour and wellbeing of women which has an
      impact on families, social life and work. Research has shown that women with PMS reported
      additional days missed at work compared to women that do not suffer with PMS. A study done by
      Brohi et al. (2011) showed that PMS is a common problem that occurs in 81.25% of women and
      has an adverse impact on a woman's quality of life. Conventional treatment is limited, not
      always effective and is associated with many side effects. Research using individualised
      homeopathic treatment, known as the homeopathic similimum, in PMS has shown to be well
      tolerated as well as have a positive impact on the symptoms of PMS although further research
      is warranted in this regard. There have not been any studies done on homeopathic treatment in
      Indian females in South Africa.

      The aim of this study is to determine the effect of individualised homeopathic treatment on
      females of Indian origin who are suffering with symptoms of PMS, using observational studies.
    

Detailed description: 
      This study will be a 12 week observational study of an embedded mixed method design and will
      be conducted over 12 weeks, consisting of four consultations 4 weeks apart, at the
      Homeopathic Health Centre, University of Johannesburg Doornfontein Campus. Ten South African
      Indian females, between 18-40 years of age, who experience PMS symptoms will be recruited
      through the placement of advertisements placed at health stores, homoeopathic/medical
      practices and on the University campus (with the relevant permission granted).

      Each participant must meet the criteria of the selection questionaire. In the first
      consultation, the researcher will explain the study to the participant. The participant will
      then be requested to sign the Participant Information and Consent Form. A full case history
      will be taken using a standard homeopathic case taking form. Each participant will be given a
      PMS chart to score their symptoms every day for the following 4 weeks in order to establish
      the baseline of each participant's premenstrual symptoms. No treatment will be prescribed in
      this period.

      Participants will be reminded of their appointments via email and text message before every
      follow up consultation. Each follow-up consultation will consist of a homoeopathic case
      taking, relevant physical examination and the collection of the PMS-chart which was completed
      over the previous 4 weeks by the participant.

      After each follow-up consultation, the researcher will establish the participant's
      individualised homoeopathic remedy according to the principles of classical homoeopathy by
      using the Complete Repertory 2014 provided in Mercurius® repertory software and the standard
      Materia Medica, with the guidance of the supervisor or co-supervisor. The potency and dosage
      of each remedy will be determined in accordance with the principles of individualised
      homoeopathic prescribing as described by De Schepper. The selected remedy will then be
      dispensed to the participant. No remedy will be dispensed at week 12. The participant will
      return a completed PMS-chart, completed over a 4 week period, to the researcher at weeks 4, 8
      and 12.
    

Intervention name(s): Individualised Homeopathic Remedy
Intervention type(s): Other
Intervention description(s): Each participant will receive an individualised homoeopathic remedy prescribed according to the individualised symptoms of their PMS.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PMS; Individualised homoeopathic treatment; Indian females