The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

NCT ID: NCT01987583

Last Updated: 2014-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-03-31

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wet cupping

Intervention Type: PROCEDURE

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.

Conventional treatment

Intervention Type: OTHER

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.

Conventional treatment

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

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Other Intervention Names

Hijama; Anti-hypertension management

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia

OTHER

Sponsor Role: collaborator

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Aleyeidi

Community Medicine PHD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouran A Aleyeidi, Resident Community Medicine

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Khaled Aseri, Consultant Community Medicine

Role: STUDY_DIRECTOR

National Guard Health Affairs, King Abdulaziz Medical City

Locations

King Abdulaziz University Hospital

Jeddah, Western Region, Saudi Arabia

Countries

Saudi Arabia

References

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.

Reference Type: DERIVED

PMID: 26559364 (View on PubMed)

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id