The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females

NCT02409264 | Completed Phase 2 DMC

• 1 other identifier: JessicaLeske201005638
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insomnia Disorder

Keywords

Insomnia; Females; Homeopathy

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  The Insomnia Severity Index is a 7-item questionnaire that provides a global measure of an individual's perceived insomnia severity.

  Every 2 weeks for 8 weeks

Secondary Outcomes (1)

• Qualitative case history notes

  Every 2 weeks for 8 weeks

Study Arms (1)

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.

Other: Individualised Homeopathic Remedy

Interventions

Individualised Homeopathic Remedy OTHER

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.

Individualised Homeopathic Remedy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Janice Pellow, 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: March 31, 2015
• First Posted: April 6, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

ZA (1)