The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome

NCT02481973 | Completed Phase 2 DMC

• 1 other identifier: MoniqueChavannes200570791
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premenstrual Syndrome

Keywords

PMS; Homoeopathy; Grant Bentley Method

Outcome Measures

Primary Outcomes (1)

• PMS symptom severity as measured by the PMS chart

  The PMS chart will be conducted daily by each participant for 12 weeks.

  12 weeks

Secondary Outcomes (1)

• Changes in symptom severity as evaluated by researcher case notes

  Every 4 weeks for 12 weeks

Study Arms (1)

Individualised Homoeopathic Remedy

EXPERIMENTAL

Each participant is to receive an individualised homoeopathic remedy, prescribed according to their characteristic symptoms and confirmed my their miasmatic facial features. Although different individualised remedies may be dispensed, each remedy will be homoeopathic and prepared in accordance with the German Homoeopathic Pharmacopoeia. Each prescription will be in a potency of 30CH which will be taken once daily, according to the GBM. Sucrose pillules will used as the vehicle for each remedy.

Other: Individualised Homoeopathic Remedy

Interventions

Individualised Homoeopathic Remedy OTHER

Each participant is to receive an individualised homoeopathic remedy prescribed according to their characteristic symptoms.

Individualised Homoeopathic Remedy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reshma Patel, M.TechHom

  University of Johannesburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 25, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)