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The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

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ClinicalTrials.gov Identifier: NCT01987583
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Sponsor:
Collaborator:
Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
Information provided by (Responsible Party):
Nouran Aleyeidi, King Abdulaziz University

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 19, 2013
Results First Submitted Date  ICMJE May 13, 2014
Results First Posted Date  ICMJE June 12, 2014
Last Update Posted Date June 12, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • Systolic Blood Pressure After 4 Weeks [ Time Frame: 1 month ]
  • Diastolic Blood Pressure After 4 Weeks [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
Systolic and diastolic Blood Pressure difference between groups [ Time Frame: 6 months ]
The comparison of the systolic and diastolic BP between the intervention and control groups will take place at 4 points in time:
  • After 4 weeks
  • After 8 weeks
  • After 12 weeks
  • After 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
Incidence of Wet Cupping Side Effects in Intervention Group [ Time Frame: 1 month ]
  • Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.
  • Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients
Official Title  ICMJE The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Randomised Controlled Trial
Brief Summary

This research proposal is submitted to fulfill the requirement of the PHD degree of Community Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi Arabia.

Background: Cupping is an ancient treatment remedy that has been used for many centuries in many parts of the world. In the Middle East, Wet cupping "Hijama" is still a popular treatment because of its religious background. Despite of that, it still has little scientific evidence that proves its efficacy. Many hijama healers claim that they have observed dramatic improvement in Blood pressure control of hypertension patients. Not many studies support that. This study should help to prove or disprove this hypothesis.

Objectives:

  • To determine the efficacy of wet cupping on blood pressure among high blood pressure patients.
  • To assess the incidence of wet cupping side effects in the intervention group.

Methods: The study design is a randomised controlled trial. There will be an intervention group of high blood pressure patients who will perform hijama in addition to their usual management, and a control group of high blood pressure patients who will receive their usual anti-hypertension management only. There will be 8 weeks follow up period. After that, data entry, analysis and interpretation will take place.

Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Procedure: Wet cupping
    Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
    Other Name: Hijama
  • Other: Conventional treatment
    According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital.
    Other Name: Anti-hypertension management
Study Arms  ICMJE
  • Experimental: Wet cupping and conventional treatment

    Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.

    Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.

    Interventions:
    • Procedure: Wet cupping
    • Other: Conventional treatment
  • Active Comparator: Conventional treatment
    Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
    Intervention: Other: Conventional treatment
Publications * Aleyeidi NA, Aseri KS, Matbouli SM, Sulaiamani AA, Kobeisy SA. Effects of wet-cupping on blood pressure in hypertensive patients: a randomized controlled trial. J Integr Med. 2015 Nov;13(6):391-9. doi: 10.1016/S2095-4964(15)60197-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2014)
80
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
140
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • High BP at the time of the study (SBP 140 mmHg or more and/or DBP 90mmHg or more). For patients with DM, high BP is defined as SBP 130 mmHg or more and/or DBP 85mmHg or more.
  • Age between 19 and 65 years old.
  • Males and females

Exclusion Criteria:

  • Grade III Hypertension (SBP 180 mmHg or more and/or DBP 110 BP or more).
  • Patients with very high added risk,according to the Saudi Hypertension management guidelines. By excluding the patient who have associated clinical conditions which are: cerebrovascular disease, heart disease, renal disease, peripheral vascular disease and advanced retinopathy.
  • Patients with secondary hypertension.
  • Pregnant women.
  • If the patient performed dry cupping, wet cupping or acupuncture during the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987583
Other Study ID Numbers  ICMJE 002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nouran Aleyeidi, King Abdulaziz University
Study Sponsor  ICMJE King Abdulaziz University
Collaborators  ICMJE Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
Investigators  ICMJE
Principal Investigator: Nouran A Aleyeidi, Resident Community Medicine Netherlands: Ministry of Health, Welfare and Sports
Study Director: Khaled Aseri, Consultant Community Medicine National Guard Health Affairs, King Abdulaziz Medical City
PRS Account King Abdulaziz University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP