Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

NCT02515006 | Completed DMC

• 1 other identifier: Adwin/chr/1121
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Insomnia; Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in sleep efficiency on the Insomnia Severity Index

  From baseline to 6 Months

Secondary Outcomes (2)

• 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

Study Arms (2)

Homeopathy

EXPERIMENTAL

Individualized homeopathy treatment as a supportive care

Other: Homeopathy Medicine

Control

NO INTERVENTION

Usual Care

Interventions

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

Homeopathy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Adwin Life Care: lead
• Center For Homeopathy Research, India: collaborator
• Sonal Foundation, India: collaborator

Study Sites (2)

Center for Homeopathy Research

Ahmedabad, Gujarat, India

Location

Center for Homeopathy Research

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Tejendra H Patel, BBA

  Center for Homeopathy Research

  STUDY DIRECTOR

• Neha Sharma, PhD

  NMP Medical Research Institute

  PRINCIPAL INVESTIGATOR

• Govind Sharma, MD

  Adwin Life Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 4, 2015
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

IN (2)