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Completed

NCT Number: NCT02515006

Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

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.

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Key information

Conditions

Chronic Insomnia Cancer Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Homeopathy Research, Ahmedabad, Gujarat, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homeopathy Medicine

Other

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

Primary outcomes

  1. Changes in sleep efficiency on the Insomnia Severity Index

    Time frame: From baseline to 6 Months

Secondary outcomes

  1. Change in Anxiety and Depression on Hospital Anxiety Depression Scale

    Time frame: From Baseline to 6 Months

  2. Change in Quality of Life on Short Form-36 Scale

    Time frame: From Baseline to 6 Months

Sponsors and collaborators

Lead sponsor

Adwin Life Care

Industry

Collaborators

  • Center For Homeopathy Research, India
  • Sonal Foundation, India

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2015
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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