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Completed

NCT Number: NCT01987583

The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University Hospital

Jeddah, Western Region, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Hijama

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.

Other names: Anti-hypertension management

Primary outcomes

  1. Systolic Blood Pressure After 4 Weeks

    Time frame: 1 month

  2. Diastolic Blood Pressure After 4 Weeks

    Time frame: 1 month

Secondary outcomes

  1. Incidence of Wet Cupping Side Effects in Intervention Group

    Time frame: 1 month

    • 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 19, 2013
Registry last updated
Jun 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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