Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

This study has been completed.
Sponsor:
Collaborators:
Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
King Fahd Medical Research Centre
Information provided by (Responsible Party):
Nouran Aleyeidi, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT01853371
First received: May 7, 2013
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: May 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Procedure: Wet cupping
Other: Conventional treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Wet Cupping and Conventional Treatment

Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other. The wet cupping procedure was not done on certain 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

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.


Participant Flow:   Overall Study
    Wet Cupping and Conventional Treatment     Conventional Treatment  
STARTED     10     10  
COMPLETED     10     8  
NOT COMPLETED     0     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Wet Cupping and Conventional Treatment

Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.

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. In this study, the wet cupping procedure was not done on certain days of the lunar month.

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.

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.

Total Total of all reporting groups

Baseline Measures
    Wet Cupping and Conventional Treatment     Conventional Treatment     Total  
Number of Participants  
[units: participants]
  10     8     18  
Age  
[units: Years]
Mean ± Standard Deviation
  52.20  ± 7.22     49.43  ± 9.50     51.06  ± 8.07  
Gender  
[units: participants]
     
Female     6     5     11  
Male     4     3     7  
Basline Systolic Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation
  160.1  ± 13.5     149.4  ± 11.1     155.3  ± 13.3  
Baseline Diastolic Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation
  90.6  ± 10.3     93.5  ± 10.6     91.9  ± 10.2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Systolic Blood Pressure After 4 Weeks   [ Time Frame: 1 month ]

2.  Primary:   Diastolic Blood Pressure After 4 Weeks   [ Time Frame: 1 month ]

3.  Secondary:   Incidence of Wet Cupping Side Effects in Intervention Group   [ Time Frame: 1 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Nouran Aleyeidi
Organization: Ministry of Health
phone: 00966504304577
e-mail: dr.nouran@live.com


No publications provided


Responsible Party: Nouran Aleyeidi, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT01853371     History of Changes
Other Study ID Numbers: 001
Study First Received: May 7, 2013
Results First Received: May 11, 2014
Last Updated: May 13, 2014
Health Authority: Saudi Arabia: Ministry for Higher Education