Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515006
• Other study ID #: Adwin/chr/1121
• 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

• Cancer
• Chronic Insomnia

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