Chronic InsomniaNCT02515006
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
A study testing Homeopathy Medicine in people with Chronic Insomnia and Cancer, run by Adwin Life Care at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Insomnia, Cancer
- What is being tested?
- Homeopathy Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesIndia
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
India2 sites
Center for Homeopathy Research
Ahmedabad, Gujarat
Center for Homeopathy Research
Jaipur, Rajasthan, 302019
About this study
Official title: 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.
- Conditions
- Chronic Insomnia, Cancer
- Being tested
- Homeopathy Medicine
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathy MedicineOther
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
| Study group | Role | What they receive |
|---|---|---|
| Homeopathy | Experimental | Individualized homeopathy treatment as a supportive care Receives: Other: Homeopathy Medicine |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep efficiency on the Insomnia Severity Index
Measured: From baseline to 6 Months
Secondary outcomes (2)
Change in Anxiety and Depression on Hospital Anxiety Depression Scale
Measured: From Baseline to 6 Months
Change in Quality of Life on Short Form-36 Scale
Measured: From Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adwin Life Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center For Homeopathy Research, India, Sonal Foundation, India
- Responsible party
- Sponsor
- Investigators
- Tejendra H Patel, BBA, Study director, Center for Homeopathy ResearchNeha Sharma, PhD, Principal investigator, NMP Medical Research InstituteGovind Sharma, MD, Study chair, Adwin Life Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515006
- Sponsor's protocol ID
- Adwin/chr/1121
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer
- ClinicalTrials.gov ID
- NCT02515006
- Acronym / sponsor ID
- Adwin/chr/1121
- Conditions
- Chronic Insomnia, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Adwin Life CareIndustry (pharma, biotech, devices)
- Collaborators
- Center For Homeopathy Research, India, Sonal Foundation, India
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathy | Experimental | Other: Homeopathy MedicineIndividualized homeopathy treatment as a supportive care |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathy MedicineHomeopathy, 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 | Other | Homeopathy |
Primary outcome
Changes in sleep efficiency on the Insomnia Severity Index
Time frame: From baseline to 6 Months
2 secondary outcomes
Change in Anxiety and Depression on Hospital Anxiety Depression Scale
Time frame: From Baseline to 6 Months
Change in Quality of Life on Short Form-36 Scale
Time frame: From Baseline to 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejendra H Patel, BBA study director
Center for Homeopathy Research
Neha Sharma, PhD principal investigator
NMP Medical Research Institute
Govind Sharma, MD study chair
Adwin Life Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeopathy Medicine in people with Chronic Insomnia and Cancer, run by Adwin Life Care at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep efficiency on the Insomnia Severity Index (time frame: From baseline to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.