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Effectiveness of Laying-on-of-hands for Sickle Cell Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kiyoshi Suzuki, MOA Health Science Foundation
ClinicalTrials.gov Identifier:
NCT01518218
First received: January 21, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
Pain Crisis Recurrent
Anemia
Infection
Death
 Behavioral: laying-on-of-hands
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MOA Health Science Foundation:

Primary Outcome Measures:
  • disease-related episodes and mortality [ Time Frame: 3 years and 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • blood data [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: laying-on-of-hands Behavioral: laying-on-of-hands
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.
Other Names:
  • Okada Purifying Therapy
  • biofield therapy
No Intervention: control group Behavioral: laying-on-of-hands
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.
Other Names:
  • Okada Purifying Therapy
  • biofield therapy

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.

  Eligibility

Ages Eligible for Study:   3 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • those who wish to use other complementary and alternative therapies along with laying-on-of-hands
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518218

Locations
Congo, The Democratic Republic of the
The national medical center for sickle cell disease
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
MOA Health Science Foundation
Investigators
Study Director: Kodondi K Koto, MD, PhD The Institute of Scientific Research for Health, Kinshasa
  More Information

Additional Information:
MOA International Corporation  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kiyoshi Suzuki, president, MOA Health Science Foundation
ClinicalTrials.gov Identifier: NCT01518218     History of Changes
Other Study ID Numbers: MOA-002
Study First Received: January 21, 2012
Last Updated: January 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by MOA Health Science Foundation:
Sickle cell disease
laying-on-of-hands
morbidity
mortality

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 21, 2013