Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

This study has been completed.
Sponsor:
Collaborators:
Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
King Fahd Medical Research Centre
Information provided by (Responsible Party):
Nouran Aleyeidi, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT01853371
First received: May 7, 2013
Last updated: May 13, 2014
Last verified: May 2014

May 7, 2013
May 13, 2014
June 2013
November 2013   (final data collection date for primary outcome measure)
  • Systolic Blood Pressure After 4 Weeks [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure After 4 Weeks [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Systolic and diastolic Blood Pressure difference between groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Complete list of historical versions of study NCT01853371 on ClinicalTrials.gov Archive Site
Incidence of Wet Cupping Side Effects in Intervention Group [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients
The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Pilot Study

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 4 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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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. In this study, the wet cupping procedure was not done on certain days of the lunar month.
    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
  • Experimental: Wet cupping and conventional treatment

    Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.

    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
November 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT01853371
001
Yes
Nouran Aleyeidi, King Abdulaziz University
King Abdulaziz University
  • Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
  • King Fahd Medical Research Centre
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
King Abdulaziz University
May 2014

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