Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

Study Overview
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Brief Summary
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Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of homeopathy for insomnia.

Official Title
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Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer

Conditions
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Chronic Insomnia, Cancer

Intervention / Treatment
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* Other: Homeopathy Medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled to begin chemotherapy or radiotherapy chemotherapy or radiotherapy meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month) Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month. have the permission of their oncologists to participate. Exclusion Criteria: untreated alcohol or substance abuse or dependence, bipolar, or psychotic disordermedical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease untreated sleep disorders such as sleep apnea Taking other alternative medicines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathy<br>Individualized homeopathy treatment as a supportive care | Other: Homeopathy Medicine<br>* Homeopathy, or homeopathic medicine, is a holistic system of treatment. Individualized homeopathy remedy was based on the most characteristic and clear mental symptoms. Secondly, general symptoms were taken into account.C-potencies were provided and manufactured according to the Homeopathic Pharmacopoeia and Hahnemann's methodology. Each individualized homeopathic remedy were be prescribed in C-potencies<br>|
| No Intervention: Control<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sleep efficiency on the Insomnia Severity Index |  | From baseline to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety and Depression on Hospital Anxiety Depression Scale |  | From Baseline to 6 Months | 
| Change in Quality of Life on Short Form-36 Scale |  | From Baseline to 6 Months |