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The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

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ClinicalTrials.gov Identifier: NCT01987583
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Sponsor:
Collaborator:
Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
Information provided by (Responsible Party):
Nouran Aleyeidi, King Abdulaziz University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Procedure: Wet cupping
Other: Conventional treatment
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wet Cupping and Conventional Treatment Conventional Treatment
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 40 40
Completed 37 38
Not Completed 3 2
Arm/Group Title Wet Cupping and Conventional Treatment Conventional Treatment Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
52  (9.4) 54  (9.5) 53  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
27
  67.5%
29
  72.5%
56
  70.0%
Male
13
  32.5%
11
  27.5%
24
  30.0%
Baseline Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 40 participants 40 participants 80 participants
152  (10.7) 156  (11.3) 154  (11.1)
Baseline Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 40 participants 40 participants 80 participants
85  (7.9) 86  (10.7) 86  (9.3)
1.Primary Outcome
Title Systolic Blood Pressure After 4 Weeks
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wet Cupping and Conventional Treatment Conventional Treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: mmHg
140  (17.7) 149  (18.5)
2.Primary Outcome
Title Diastolic Blood Pressure After 4 Weeks
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wet Cupping and Conventional Treatment Conventional Treatment
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: mmHg
82  (9.9) 81  (12.2)
3.Secondary Outcome
Title Incidence of Wet Cupping Side Effects in Intervention Group
Hide Description
  • 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.
Time Frame 1 month
Outcome Measure Data Not Reported
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wet Cupping and Conventional Treatment Conventional Treatment
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Wet Cupping and Conventional Treatment Conventional Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Wet Cupping and Conventional Treatment Conventional Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wet Cupping and Conventional Treatment Conventional Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/40 (60.00%)      0/40 (0.00%)    
General disorders     
Headache   10/40 (25.00%)  13 0/40 (0.00%)  0
Dizziness   6/40 (15.00%)  7 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Itching   8/40 (20.00%)  8 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nouran Aleyeidi
Organization: Ministry of Health
Phone: 00966504304577
EMail: dr.nouran@live.com
Layout table for additonal information
Responsible Party: Nouran Aleyeidi, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT01987583    
Other Study ID Numbers: 002
First Submitted: November 13, 2013
First Posted: November 19, 2013
Results First Submitted: May 13, 2014
Results First Posted: June 12, 2014
Last Update Posted: June 12, 2014