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
  Purpose

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


Condition Intervention
Hypertension
Procedure: Wet cupping
Other: Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Pilot Study

Resource links provided by NLM:


Further study details as provided by King Abdulaziz University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: June 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853371

Locations
Saudi Arabia
King Abdulaziz University Hospital
Jeddah, Western region, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University
Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
King Fahd Medical Research Centre
Investigators
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
  More Information

No publications provided

Responsible Party: Nouran Aleyeidi, Community Medicine PHD Candidate, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT01853371     History of Changes
Other Study ID Numbers: 001
Study First Received: May 7, 2013
Results First Received: May 11, 2014
Last Updated: May 13, 2014
Health Authority: Saudi Arabia: Ministry for Higher Education

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014