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| Name | Class |
|---|---|
| Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional treatment | Active Comparator | Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure After 4 Weeks | 1 month | |
| Diastolic Blood Pressure After 4 Weeks | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Wet Cupping Side Effects in Intervention Group |
| 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz University Hospital | Jeddah | Western Region | 21589 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26559364 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| FG001 | Conventional Treatment | Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure After 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 1 month |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nouran Aleyeidi | Ministry of Health | 00966504304577 | dr.nouran@live.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| 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. |
|
|
| BG001 | Conventional Treatment | Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Baseline Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| OG001 | Conventional Treatment | Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department 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. |
|
|
| Secondary | Incidence of Wet Cupping Side Effects in Intervention Group |
| Not Posted | 1 month |
| Primary | Diastolic Blood Pressure After 4 Weeks | Posted | Mean | Standard Deviation | mmHg | 1 month |
|
|
|
| 0 |
| 40 |
| 24 |
| 40 |
| EG001 | Conventional Treatment | Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department 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. | 0 | 40 | 0 | 40 |
| Dizziness | General disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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