Back to resultsImpact of Homeopathy for Persistent Insomnia in Patients With Cancer
Primary Purpose
Chronic Insomnia, Cancer
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Homeopathy Medicine
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Insomnia
Eligibility Criteria
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
Sites / Locations
- Center for Homeopathy Research
- Center for Homeopathy Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Homeopathy
Control
Arm Description
Individualized homeopathy treatment as a supportive care
Usual Care
Outcomes
Primary Outcome Measures
Changes in sleep efficiency on the Insomnia Severity Index
Secondary Outcome Measures
Change in Anxiety and Depression on Hospital Anxiety Depression Scale
Change in Quality of Life on Short Form-36 Scale
Full Information
NCT ID
NCT02515006
First Posted
July 30, 2015
Last Updated
August 2, 2015
Sponsor
Adwin Life Care
Collaborators
Center For Homeopathy Research, India, Sonal Foundation, India
1. Study Identification
Unique Protocol Identification Number
NCT02515006
Brief Title
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
Official Title
Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adwin Life Care
Collaborators
Center For Homeopathy Research, India, Sonal Foundation, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Homeopathy
Arm Type
Experimental
Arm Description
Individualized homeopathy treatment as a supportive care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Homeopathy Medicine
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in sleep efficiency on the Insomnia Severity Index
Time Frame
From baseline to 6 Months
Secondary Outcome Measure Information:
Title
Change in Anxiety and Depression on Hospital Anxiety Depression Scale
Time Frame
From Baseline to 6 Months
Title
Change in Quality of Life on Short Form-36 Scale
Time Frame
From Baseline to 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tejendra H Patel, BBA
Organizational Affiliation
Center for Homeopathy Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Govind Sharma, MD
Organizational Affiliation
Adwin Life Care
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Homeopathy Research
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Center for Homeopathy Research
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302019
Country
India
12. IPD Sharing Statement
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