Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The study is of an embedded mixed method design using the PMS chart and case studies and will take place over 12 weeks at the University of Johannesburg (UJ) Health Centre. Using purposive sampling, 10 female participants between the ages of 18 to 40 years will be recruited by means of advertisements at the Homoeopathic Health Centre, campus gym and female residences on the Doornfontein campus of the University of Johannesburg, as well as various health shops, practices and gyms in the Auckland Park and Killarney areas, with the relevant permission granted.

Each potential participant will be required to complete a screening questionnaire in order to establish whether they are an appropriate candidate for this study. Once this is confirmed, the researcher will explain the study to each participant. The participants will be required to read the participant information form and sign the consent and medical photograph consent forms. Participants will be informed that their photographs will be used for facial analysis to assist in finding the most accurate remedy and will not be published. Each participant's facial features will be hand-drawn by the researcher in order to aid participant confidentiality.

Each participant will undergo a full homoeopathic consultation which will focus on her PMS symptoms. In addition, 9 photos of their facial features will be taken with a digital camera (Panasonic DMC-FZ5) for classification of their dominant miasmatic group. Thereafter, a physical examination including vital signs and an abdominal and/or breast examination (if indicated) will be conducted.

After the consultation, the participant will be asked to record their daily PMS symptoms, for a period of 1 month, on the PMS chart (provided to them by the researcher) at home. The first month will act as a baseline measurement as no treatment will be prescribed. Additionally, the researcher will analyse and repertorise the participant's case in this period. The participant will be grouped into their dominant miasmatic group and the corresponding remedy will be selected, according to the principles of homoeopathy and GBM of prescribing, for use in the following consultation. Remedy selections will be supervised by a registered homoeopath.

The follow-up consultations will be conducted at weeks 4, 8 and 12, wherein participants will hand in their completed PMS charts and undergo any relevant physical examinations. The participant will then receive their individualised remedy, as determined by the researcher, along with an explanation as to how to store and take the remedy. They will additionally receive another PMS chart to complete over the following 4 weeks. Photographs may be retaken to re-analysed the case if necessary as to ensure the correct selection of the remedy using the GBM during the study.

Should the participant want further treatment at the completion of the study, they will be appropriately referred to a registered homoeopath or to the UJ Homoeopathic Health Centre.

A positive result of this research would indicate the viability of the GBM as a useful tool to aid in the individualised homoeopathic treatment and therefore aid in successful prescribing in the treatment of PMS. Additionally, a positive result would indicate homoeopathy as a potential treatment for PMS. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT02481973
Study type Interventional
Source University of Johannesburg
Contact
Status Completed
Phase Phase 2
Start date September 2014
Completion date October 2015

See also
  Status Clinical Trial Phase
Completed NCT00195559 - Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder Phase 3
Completed NCT00048854 - Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder Phase 1/Phase 2
Completed NCT00965562 - Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) N/A
Completed NCT05349344 - Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS). N/A
Recruiting NCT06146673 - A Multidimensional Study of Premenstrual Syndrome and Body Image
Recruiting NCT05836454 - The Soft Tissue Mobilization Techniques on PMS N/A
Completed NCT05499000 - The Effect of Emotional Freedom Technique on Premenstrual Syndrome N/A
Recruiting NCT06144073 - The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome N/A
Recruiting NCT06105567 - The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress N/A
Completed NCT03298607 - The Impact of Serelys PMS on Symptoms of PMS Phase 3
Recruiting NCT06176313 - Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms N/A
Recruiting NCT02562053 - Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? Phase 3
Completed NCT00229346 - Fibromyalgia and Psychiatric Symptoms Among PMS and PMDD Patients N/A
Completed NCT00516113 - A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria Phase 4
Completed NCT04901598 - Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome
Completed NCT05692479 - Premenstrual Syndrome and Physical Activity Self-Worth
Not yet recruiting NCT06052722 - The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders N/A
Completed NCT05665972 - Effects of Mandala Coloring on Premenstrual Syndrome N/A
Completed NCT05556252 - The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life N/A
Completed NCT05725447 - Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)