Premenstrual Syndrome Clinical Trial
Official title:
The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome
Premenstrual syndrome (PMS) is related to the changes in the levels of hormones
predominately progesterone, oestrogen and prolactin, during the luteal phase of the
menstrual cycle. Both physical and psychological symptoms may occur from at least day 14 of
the menstruation cycle and cease by day 4 of menstruation. The symptoms may interfere with a
female's daily activities and have a negative impact well-being. There are a number of
conventional pharmacological drugs which are used in the treatment or alleviation of the
symptoms of PMS, however the drugs may have side effects and may negatively interact with
other medications. Research has shown that homoeopathy is beneficial in relieving or
decreasing the severity of PMS, however finding the individualised homoeopathic remedy can
be difficult. Grant Bentley developed a system that helps find the most suitable remedy for
each individual case. The Grant Bentley Method (GBM) uses homoeopathic case taking,
photographs of the facial features and repertorisation to determine the dominant miasmatic
group of the patient. This aids in the selection of specific homoeopathic remedy. There has
been no research to show the effect of the GBM on PMS.
This study aims to determine the effect of individualised homoeopathic treatment using the
GBM, on females with PMS by using case studies and a daily self-grading PMS chart.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Females (aged 18-40) suffering from at least one PMS symptom from both of the following physical and psychological symptoms, for at least 3 consecutive menstrual cycles: - Physical symptoms: headache, breast tenderness, abdominal bloating, food cravings and swelling of extremities - Psychological symptoms: depression, anxiety, irritability, social withdrawal and memory changes; - symptoms that are present from at least day 14 (2 weeks before menstruation) of the menstrual cycle, are relieved by day 4 of menstruation, and do not reoccur until after day 13 of the menstrual cycle; and - if currently on the OCP, they must be using the same brand of medication for 3 consecutive months. Exclusion Criteria: - Females on any kind of chronic medication that may interfere with PMS symptoms such as medication for hyperthyroidism, hypothyroidism, diabetes mellitus and psychiatric disorders; - are suffering from dysphoric disorder (a severe form of premenstrual syndrome); - are on hormonal treatment (except OCP); - have been pre-diagnosed with any anxiety or depression disorders; and/or - have irregular menses. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | University of Johannesburg | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
University of Johannesburg |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PMS symptom severity as measured by the PMS chart | The PMS chart will be conducted daily by each participant for 12 weeks. | 12 weeks | No |
Secondary | Changes in symptom severity as evaluated by researcher case notes | Case notes will be taken every 4 weeks in each consultation and will be used to collect qualitative data. | Every 4 weeks for 12 weeks | No |
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