HypertensionNCT01987583
The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients
A study testing Wet cupping and Conventional treatment in people with Hypertension, run by King Abdulaziz University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Wet cupping and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University Hospital
Jeddah, Western Region, 21589
About this study
Official title: The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Randomised Controlled Trial
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.
Read more
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
- Being tested
- Wet cupping, Conventional treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet cuppingProcedure or surgery
Also called Hijama
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 treatmentOther
Also called Anti-hypertension management
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.
| Study group | Role | What they receive |
|---|---|---|
| Wet cupping and conventional treatment | Experimental | 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. Receives: 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 Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure After 4 Weeks
Measured: 1 month
Diastolic Blood Pressure After 4 Weeks
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
- Responsible party
- Principal investigator, Nouran Aleyeidi, King Abdulaziz University
- Investigators
- Nouran A Aleyeidi, Resident Community Medicine, Principal investigator, Ministry of HealthKhaled Aseri, Consultant Community Medicine, Study director, National Guard Health Affairs, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987583
- Sponsor's protocol ID
- 002
- Status last verified
- May 2014
- First submitted
- 13 Nov 2013
- Last updated
- 12 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26559364
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01987583
- Acronym / sponsor ID
- 002
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Collaborators
- Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 12 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wet cupping and conventional treatment | Experimental | Procedure: Wet cupping, Other: Conventional treatmentWet 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. |
| Conventional treatment | Active comparator | Other: Conventional treatmentConventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wet cuppingAlso: HijamaWet 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. | Procedure or surgery | Wet cupping and conventional treatment |
| Conventional treatmentAlso: Anti-hypertension managementAccording 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 | Conventional treatment, Wet cupping and conventional treatment |
Primary outcome
Systolic Blood Pressure After 4 Weeks
Time frame: 1 month
Diastolic Blood Pressure After 4 Weeks
Time frame: 1 month
1 secondary outcome
Incidence of Wet Cupping Side Effects in Intervention Group
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26559364Aleyeidi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouran A Aleyeidi, Resident Community Medicine principal investigator
Ministry of Health
Khaled Aseri, Consultant Community Medicine study director
National Guard Health Affairs, King Abdulaziz Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet cupping and Conventional treatment in people with Hypertension, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure After 4 Weeks (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2014.