The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

Hypertension Clinical Trial

Official title:

The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987583
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: May 13, 2014
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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:
• 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.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University Hospital	Jeddah	Western region

Sponsors (2)

Lead Sponsor	Collaborator
King Abdulaziz University	Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure After 4 Weeks		1 month	No
Primary	Diastolic Blood Pressure After 4 Weeks		1 month	No
Secondary	Incidence of Wet Cupping Side Effects in Intervention Group	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.	1 month	Yes