Premenstrual SyndromePhase 2NCT02467088
An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome
A Phase 2 study testing Individualised Homeopathic Remedy in people with Premenstrual Syndrome, run by University of Johannesburg at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Individualised Homeopathic Remedy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2014to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2094
About this study
Official title: An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome in Indian Females
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.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Individualised Homeopathic Remedy
- Keywords
- PMS, Individualised homoeopathic treatment, Indian females
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised Homeopathic RemedyOther
Each participant will receive an individualised homoeopathic remedy prescribed according to the individualised symptoms of their PMS.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Individualised Homeopathic Remedy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 12 weeks
Secondary outcomes (1)
Case notes on patient symptoms and wellbeing
Qualitative data will be collected by the researcher from the participant at weeks 0, 4, 8 and 12 using case notes.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Reshma Patel, MTech.Hom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467088
- Sponsor's protocol ID
- MaseehaBulbulia200700939
- Status last verified
- May 2016
- First submitted
- 14 May 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome in Indian Females
- ClinicalTrials.gov ID
- NCT02467088
- Acronym / sponsor ID
- MaseehaBulbulia200700939
- Conditions
- Premenstrual Syndrome
- Keywords
- PMS, Individualised homoeopathic treatment, Indian females
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualised Homoeopathic Remedy | Experimental | Other: Individualised Homeopathic RemedyEach 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualised Homeopathic RemedyEach participant will receive an individualised homoeopathic remedy prescribed according to the individualised symptoms of their PMS. | Other | Individualised Homoeopathic Remedy |
Primary outcome
PMS symptoms severity on PMS chart
Time frame: 12 weeks
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".
1 secondary outcome
Case notes on patient symptoms and wellbeing
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reshma Patel, MTech.Hom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individualised Homeopathic Remedy in people with Premenstrual Syndrome, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PMS symptoms severity on PMS chart (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.