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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02515006
Other study ID # Adwin/chr/1121
Secondary ID
Status Completed
Phase N/A
First received July 30, 2015
Last updated August 2, 2015
Start date September 2014
Est. completion date June 2015

Study information

Verified date August 2015
Source Adwin Life Care
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Homeopathy Medicine
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

Locations

Country Name City State
India Center for Homeopathy Research Ahmedabad Gujarat
India Center for Homeopathy Research Jaipur Rajasthan

Sponsors (3)

Lead Sponsor Collaborator
Adwin Life Care Center For Homeopathy Research, India, Sonal Foundation, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in sleep efficiency on the Insomnia Severity Index From baseline to 6 Months No
Secondary Change in Anxiety and Depression on Hospital Anxiety Depression Scale From Baseline to 6 Months No
Secondary Change in Quality of Life on Short Form-36 Scale From Baseline to 6 Months No
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