Sickle Cell DiseasePhase 2NCT01518218
Effectiveness of Laying-on-of-hands for Sickle Cell Disease
A Phase 2 study testing laying-on-of-hands in people with Sickle Cell Disease and Pain Crisis Recurrent, run by MOA Health Science Foundation at 1 site in Democratic Republic of the Congo.
Trial summary
The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa. Read more about this study
- Who is it for?
- Ages 3 to 40 years
- Conditions the study is for
- Sickle Cell Disease, Pain Crisis Recurrent, Anemia
- What is being tested?
- laying-on-of-hands
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Mar 2006to Dec 2009
- Phase
- Phase 2
- 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 3 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with symptoms associated with sickle cell disease
- those able to receive laying-on-of-hands every weekday for 1 year
- those able to receive conventional medical treatment whenever necessary
- those able to receive blood test at the beginning, after 6 month and after 1 year
Who cannot join
- those who wish to use other complementary and alternative therapies along with laying-on-of-hands
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
The national medical center for sickle cell disease
Kinshasa
About this study
Official title: Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa
The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.
Read the detailed description
Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated.
- Conditions
- Sickle Cell Disease, Pain Crisis Recurrent, Anemia, Infection, Death
- Being tested
- laying-on-of-hands
- Keywords
- Sickle cell disease, laying-on-of-hands, morbidity, mortality
- Medical subject headings
- Anemia, Sickle Cell, Anemia, Infections, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laying-on-of-handsBehavioural
Also called Okada Purifying Therapy, biofield therapy
The intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT.
| Study group | Role | What they receive |
|---|---|---|
| laying-on-of-hands | Experimental | Patients of this arm received laying-on-of-hands twice a day (45 minutes each) every weekday for 1year, and received conventional medical treatment if necessary. Receives: Behavioral: laying-on-of-hands |
| control group | No intervention | Patients of this arm did not receive any alternatives other than conventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-related episodes and mortality
Measured: 3 years and 9 months
Secondary outcomes (1)
blood data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MOA Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyoshi Suzuki, MOA Health Science Foundation
- Investigators
- Kodondi K Koto, MD, PhD, Study director, The Institute of Scientific Research for Health, Kinshasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518218
- Sponsor's protocol ID
- MOA-002
- Status last verified
- Jan 2012
- First submitted
- 21 Jan 2012
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Minga TM, Koto FK, Egboki H, Suzuki K. Effectiveness of biofield therapy for individuals with sickle cell disease in Africa. Altern Ther Health Med. 2014 Jan-Feb;20(1):20-6.
PubMed 24445353
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa
- ClinicalTrials.gov ID
- NCT01518218
- Acronym / sponsor ID
- MOA-002
- Conditions
- Sickle Cell Disease, Pain Crisis Recurrent, Anemia, Infection, Death
- Keywords
- Sickle cell disease, laying-on-of-hands, morbidity, mortality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MOA Health Science FoundationUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jan 2012 (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.
The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.
Detailed description
Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laying-on-of-hands | Experimental | Behavioral: laying-on-of-handsPatients of this arm received laying-on-of-hands twice a day (45 minutes each) every weekday for 1year, and received conventional medical treatment if necessary. |
| control group | No intervention | –Patients of this arm did not receive any alternatives other than conventional treatment. |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patients with symptoms associated with sickle cell disease
- those able to receive laying-on-of-hands every weekday for 1 year
- those able to receive conventional medical treatment whenever necessary
- those able to receive blood test at the beginning, after 6 month and after 1 year
Key exclusion criteria (1 listed)
- those who wish to use other complementary and alternative therapies along with laying-on-of-hands
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 |
|---|---|---|
| laying-on-of-handsAlso: Okada Purifying Therapy, biofield therapyThe intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT. | Behavioural | laying-on-of-hands |
Primary outcome
disease-related episodes and mortality
Time frame: 3 years and 9 months
1 secondary outcome
blood data
Time frame: 1 year
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 13 Apr 2015.
- Derived from this study: PubMed 24445353Minga TM, Koto FK, Egboki H, Suzuki K. Effectiveness of biofield therapy for individuals with sickle cell disease in Africa. Altern Ther Health Med. 2014 Jan-Feb;20(1):20-6.
- MOA International CorporationLink provided by the sponsor.
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
Kodondi K Koto, MD, PhD study director
The Institute of Scientific Research for Health, Kinshasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laying-on-of-hands in people with Sickle Cell Disease and Pain Crisis Recurrent, run by MOA Health Science Foundation at 1 site in Democratic Republic of the Congo.
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 4 inclusion and 1 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
disease-related episodes and mortality (time frame: 3 years and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518218, which also lists 1 linked publication.
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 13 Apr 2015.