Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

NCT ID: NCT02515006

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Chronic Insomnia Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Homeopathy

Individualized homeopathy treatment as a supportive care

Group Type EXPERIMENTAL

Homeopathy Medicine

Intervention Type 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

Control

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center For Homeopathy Research, India

UNKNOWN

Sponsor Role collaborator

Sonal Foundation, India

OTHER

Sponsor Role collaborator

Adwin Life Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tejendra H Patel, BBA

Role: STUDY_DIRECTOR

Center for Homeopathy Research

Neha Sharma, PhD

Role: PRINCIPAL_INVESTIGATOR

NMP Medical Research Institute

Govind Sharma, MD

Role: STUDY_CHAIR

Adwin Life Care

Locations

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Center for Homeopathy Research

Ahmedabad, Gujarat, India

Site Status

Center for Homeopathy Research

Jaipur, Rajasthan, India

Site Status

Countries

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India

Other Identifiers

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Adwin/chr/1121

Identifier Type: -

Identifier Source: org_study_id

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