Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

August 2, 2015 updated by: Adwin Life Care

Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Center for Homeopathy Research
    • Rajasthan
      • Jaipur, Rajasthan, India, 302019
        • Center for Homeopathy Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
Experimental: Homeopathy
Individualized homeopathy treatment as a supportive care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in sleep efficiency on the Insomnia Severity Index
Time Frame: From baseline to 6 Months
From baseline to 6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Anxiety and Depression on Hospital Anxiety Depression Scale
Time Frame: From Baseline to 6 Months
From Baseline to 6 Months
Change in Quality of Life on Short Form-36 Scale
Time Frame: From Baseline to 6 Months
From Baseline to 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adwin Life Care

Collaborators

Center For Homeopathy Research, India
Sonal Foundation, India

Investigators

  • Study Director: Tejendra H Patel, BBA, Center for Homeopathy Research
  • Principal Investigator: Neha Sharma, PhD, NMP Medical Research Institute
  • Study Chair: Govind Sharma, MD, Adwin Life Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 2, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 2, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adwin/chr/1121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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