An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome

NCT02467088 | Completed Phase 2 DMC

• 1 other identifier: MaseehaBulbulia200700939
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premenstrual Syndrome

Keywords

PMS; Individualised homoeopathic treatment; Indian females

Outcome Measures

Primary Outcomes (1)

• PMS symptoms severity on PMS chart

  The PMS chart will be completed every day for 12 weeks, recording the participant's symptoms based on the most characteristic PMS symptoms and has been used in previous PMS studies. The evaluation of symptoms is subjective and is based on a 5 point scale: 0 - "no symptom", 1- "very mild", 2 - "mild", 3 - "severe", 4 - "extremely severe".

  12 weeks

Secondary Outcomes (1)

• Case notes on patient symptoms and wellbeing

  12 weeks

Study Arms (1)

Individualised Homoeopathic Remedy

EXPERIMENTAL

Each participant will receive an individualised homoeopathic remedy, in a vehicle of sucrose pillules, according to the symptoms of their PMS. Although different individualised remedies may be dispensed, each remedy will be homoeopathic. Each individualised homoeopathic remedy will have an individualised dosage, frequency and duration based on the laws of individualised homoeopathic prescribing as outlined by De Schepper.

Other: Individualised Homeopathic Remedy

Interventions

Individualised Homeopathic Remedy OTHER

Each participant will receive an individualised homoeopathic remedy prescribed according to the individualised symptoms of their PMS.

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 between ages of 18 and 40 years who experience PMS on a monthly basis;
• females who experience an increase in at least one of the following mental and physical symptoms at least fourteen days before their menses begin, in each of the three preceding menstrual cycles: Mental symptoms: irritability, depression or anxiety Physical symptoms: breast tenderness or swelling, abdominal bloating, headaches, swelling of extremities or food cravings; and
• females who have an amelioration of the above symptoms within three days of the onset of menses and symptoms should not reoccur until at least day thirteen of the cycle.

You may not qualify if:

• Irregular menstrual cycles;
• lactating females;
• prediagnosed anxiety and depression;
• use of sex hormones except the oral contraceptive (must have been used for a minimum of 3 months) or concomitant psychotherapies and alternate therapies for PMS
• pregnant females

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2094, South Africa

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Reshma Patel, MTech.Hom

  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 J. Pellow

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: June 9, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)