Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

Not Applicable

Completed

• Conditions: Cancer; Chronic Insomnia
• Interventions: Other: Homeopathy Medicine

• Registration Number: NCT02515006
• Lead Sponsor: Adwin Life Care

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Study First Submitted: 2015-07-30
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-02
• Last Update Submitted: 2015-08-02
• Study First Posted: 2015-08-04
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homeopathy	Homeopathy Medicine	Individualized homeopathy treatment as a supportive care

Primary Outcome Measures

Name	Time	Method
Changes in sleep efficiency on the Insomnia Severity Index	From baseline to 6 Months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Homeopathy Research; 🇮🇳 Jaipur, Rajasthan, India