Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

NCT01853371 | Completed Results DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure After 4 Weeks

  1 month

• Diastolic Blood Pressure After 4 Weeks

  1 month

Secondary Outcomes (1)

• Incidence of Wet Cupping Side Effects in Intervention Group

  1 month

Study Arms (2)

Wet cupping and conventional treatment

EXPERIMENTAL

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; Other: Conventional treatment

Conventional treatment

ACTIVE COMPARATOR

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

Other: Conventional treatment

Interventions

Wet cupping 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. In this study, the wet cupping procedure was not done on certain days of the lunar month.

Also known as: Hijama

Wet cupping and conventional treatment

Conventional treatment 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.

Also known as: Anti-hypertension management

Conventional treatment; Wet cupping and conventional treatment

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead
• Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia: collaborator
• King Fahd Medical Research Centre: collaborator

Study Sites (1)

King Abdulaziz University Hospital

Jeddah, Western Region, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Nouran Aleyeidi
• Organization: Ministry of Health

dr.nouran@live.com

00966504304577

Study Officials

• Nouran A Aleyeidi, Resident Community Medicine

  Ministry of Health

  PRINCIPAL INVESTIGATOR

• Khaled Aseri, Consultant Community Medicine

  National Guard Health Affairs, King Abdulaziz Medical City

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Community Medicine PHD Candidate

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 15, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Last Updated: December 11, 2014
• Results First Posted: June 12, 2014

Record last verified: 2014-11

Locations

SA (1)