Insomnia DisorderPhase 2NCT02409264
The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females
A Phase 2 study testing Individualised Homeopathic Remedy in people with Insomnia Disorder, run by University of Johannesburg at 1 site in South Africa.
Trial summary
In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties, and may exacerbate symptomatology of co-morbid diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia Disorder
- 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
- Jan 2015to 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 18 years to 45 years.
- Participants must fulfil the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition Text Revision (DSM-V TR):
- A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: difficulty initiating sleep; difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings; and/or early-morning awakening with inability to return to sleep
- The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioural, or other important areas of functioning
- The sleep difficulty occurs at least 3 nights per week
- The sleep difficulty is present for at least 3 months
Show all 10Show fewer
- The sleep difficulty occurs despite adequate opportunity for sleep
- The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia)
- The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication)
- Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
Who cannot join
- Pregnant or lactating women
- Participants suffering from narcolepsy, a breathing-related sleep disorder, circadian rhythm sleep disorder, or a parasomnia
- Participants diagnosed with major depressive disorder, generalised anxiety disorder, a delirium, or schizophrenia
- Participants using conventional psychological or drug therapies, or herbal, or homeopathic medication for their insomnia
- Participants taking recreational or prescription drugs which have insomnia as a side effect.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties, and may exacerbate symptomatology of co-morbid diseases. Current conventional treatment for insomnia includes both psychological and drug therapies. These conventional medications potentially may lead to dependency and withdrawal symptoms. Individualised homeopathic treatment is a process in which a homeopath selects the most appropriate remedy for the treatment of a condition in accordance with the fundamental principles of homeopathy. This treatment protocol may offer safe and effective treatment for insomnia disorder, however, more research is required on the subject. The aim of this study is to determine the effect of individualised homeopathic treatment of insomnia disorder in females using detailed case studies and the Insomnia Severity Index.
Read the detailed description
This study will be of an embedded mixed method case study design, conducted at the University of Johannesburg Doornfontein Homeopathic Health Clinic over a period of 8 weeks. Ten female participants, aged 18 to 45 years, will be recruited by means of non-probability purposive sampling via advertisements placed in the University of Johannesburg Homeopathic Health Clinic and in pharmacies around Johannesburg, with the relevant permission given.
The nature of the study, as well as the requirements for participation will be fully explained and the volunteers will be asked to sign the Participant Information and Consent Form once they agree to participate. Potential participants will undergo a brief screening to determine if they meet the requirements for this study. The participants that meet the inclusion criteria will attend the initial consultation and those that do not meet the inclusion criteria will be referred to the Homeopathic Health Clinic.
The consultation will consist of a comprehensive homeopathic case history, the conduction of relevant physical exams, including vital signs, and the completion of the Insomnia Severity Index (ISI). The participant's case will be analysed and computer repertorised, using the Complete Repertory of Mercurius homeopathic software (Aeon Group), version 5.3.0.17. The individualised homeopathic remedy will be selected by the researcher who will refer to the appropriate Materia Medica. The Homeopathic Dispenser will dispense the homeopathic remedy to the participant.
Each participant will return for four follow-up consultations which will be two weeks apart. At each follow-up consultation the ISI will be completed and a follow-up case history and physical examination of the participants' vital signs will be conducted. The participants' symptoms will be re-evaluated and a remedy prescribed accordingly. At the final consultation in the 8th week, no remedy will be prescribed.
Data will be collected and analysed by the researcher with the assistance of a statistician at Statkon, using non-parametric tests, including: frequencies and descriptives, the Friedman test, and Wilcoxon post hoc test.
The possible outcome of this study may demonstrate that individualised homeopathic treatment is effective in reducing the frequency and intensity of insomnia disorder in females, and instigate further research on the subject.
- Conditions
- Insomnia Disorder
- Being tested
- Individualised Homeopathic Remedy
- Keywords
- Insomnia, Females, Homeopathy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised Homeopathic RemedyOther
Sucrose pillules will be medicated with the individualised homeopathic remedy as determined by the researcher, in the potency, dosage and repetition determined by the researcher in accordance with the laws governing homeopathic prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Individualised Homeopathic Remedy | Experimental | Sucrose pillules will be medicated with the determined individualised homeopathic remedy, in the potency decided by the researcher in accordance with the laws that govern homeopathic prescribing. The dose and repetition of the remedy will be determined by the researcher in accordance with the aforementioned laws. A remedy will be prescribed every 2 weeks, after its determination by the researcher. No remedy will be prescribed after week 8. Receives: Other: Individualised Homeopathic Remedy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The Insomnia Severity Index is a 7-item questionnaire that provides a global measure of an individual's perceived insomnia severity.
Measured: Every 2 weeks for 8 weeks
Secondary outcomes (1)
Qualitative case history notes
Case notes taken by the researcher with regard to the participants' symptoms, characteristics and wellbeing, which are used to determine the individualised homeopathic remedy and collect qualitative data from each participant.
Measured: Every 2 weeks for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJan 2015
- 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 Insomnia DisorderStudies 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
- Janice Pellow, M.TechHom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409264
- Sponsor's protocol ID
- JessicaLeske201005638
- Status last verified
- May 2016
- First submitted
- 31 Mar 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females
- ClinicalTrials.gov ID
- NCT02409264
- Acronym / sponsor ID
- JessicaLeske201005638
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, Females, Homeopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Apr 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.
In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties, and may exacerbate symptomatology of co-morbid diseases. Current conventional treatment for insomnia includes both psychological and drug therapies. These conventional medications potentially may lead to dependency and withdrawal symptoms. Individualised homeopathic treatment is a process in which a homeopath selects the most appropriate remedy for the treatment of a condition in accordance with the fundamental principles of homeopathy. This treatment protocol may offer safe and effective treatment for insomnia disorder, however, more research is required on the subject. The aim of this study is to determine the effect of individualised homeopathic treatment of insomnia disorder in females using detailed case studies and the Insomnia Severity Index.
Detailed description
This study will be of an embedded mixed method case study design, conducted at the University of Johannesburg Doornfontein Homeopathic Health Clinic over a period of 8 weeks. Ten female participants, aged 18 to 45 years, will be recruited by means of non-probability purposive sampling via advertisements placed in the University of Johannesburg Homeopathic Health Clinic and in pharmacies around Johannesburg, with the relevant permission given.
The nature of the study, as well as the requirements for participation will be fully explained and the volunteers will be asked to sign the Participant Information and Consent Form once they agree to participate. Potential participants will undergo a brief screening to determine if they meet the requirements for this study. The participants that meet the inclusion criteria will attend the initial consultation and those that do not meet the inclusion criteria will be referred to the Homeopathic Health Clinic.
The consultation will consist of a comprehensive homeopathic case history, the conduction of relevant physical exams, including vital signs, and the completion of the Insomnia Severity Index (ISI). The participant's case will be analysed and computer repertorised, using the Complete Repertory of Mercurius homeopathic software (Aeon Group), version 5.3.0.17. The individualised homeopathic remedy will be selected by the researcher who will refer to the appropriate Materia Medica. The Homeopathic Dispenser will dispense the homeopathic remedy to the participant.
Each participant will return for four follow-up consultations which will be two weeks apart. At each follow-up consultation the ISI will be completed and a follow-up case history and physical examination of the participants' vital signs will be conducted. The participants' symptoms will be re-evaluated and a remedy prescribed accordingly. At the final consultation in the 8th week, no remedy will be prescribed.
Data will be collected and analysed by the researcher with the assistance of a statistician at Statkon, using non-parametric tests, including: frequencies and descriptives, the Friedman test, and Wilcoxon post hoc test.
The possible outcome of this study may demonstrate that individualised homeopathic treatment is effective in reducing the frequency and intensity of insomnia disorder in females, and instigate further research on the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualised Homeopathic Remedy | Experimental | Other: Individualised Homeopathic RemedySucrose pillules will be medicated with the determined individualised homeopathic remedy, in the potency decided by the researcher in accordance with the laws that govern homeopathic prescribing. The dose and repetition of the remedy will be determined by the researcher in accordance with the aforementioned laws. A remedy will be prescribed every 2 weeks, after its determination by the researcher. No remedy will be prescribed after week 8. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Females aged 18 years to 45 years.
- Participants must fulfil the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition Text Revision (DSM-V TR):
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Participants suffering from narcolepsy, a breathing-related sleep disorder, circadian rhythm sleep disorder, or a parasomnia
- Participants diagnosed with major depressive disorder, generalised anxiety disorder, a delirium, or schizophrenia
- Participants using conventional psychological or drug therapies, or herbal, or homeopathic medication for their insomnia
- Participants taking recreational or prescription drugs which have insomnia as a side effect.
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 RemedySucrose pillules will be medicated with the individualised homeopathic remedy as determined by the researcher, in the potency, dosage and repetition determined by the researcher in accordance with the laws governing homeopathic prescribing. | Other | Individualised Homeopathic Remedy |
Primary outcome
Insomnia Severity Index
Time frame: Every 2 weeks for 8 weeks
The Insomnia Severity Index is a 7-item questionnaire that provides a global measure of an individual's perceived insomnia severity.
1 secondary outcome
Qualitative case history notes
Time frame: Every 2 weeks for 8 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 17 May 2016.
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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.
Janice Pellow, M.TechHom 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 Insomnia Disorder, 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 10 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 17 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?
Insomnia Severity Index (time frame: Every 2 weeks for 8 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 17 May 2016.