Trial Outcomes & Findings for The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients (NCT NCT01987583)

NCT ID: NCT01987583

Last Updated: 2014-06-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2014-06-12

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	40	40
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

Baseline characteristics by cohort

Measure	Wet Cupping and Conventional Treatment n=40 Participants 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 n=40 Participants 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 n=80 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 9.4 • n=5 Participants	54 years STANDARD_DEVIATION 9.5 • n=7 Participants	53 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Baseline Systolic Blood Pressure	152 mmHg STANDARD_DEVIATION 10.7 • n=5 Participants	156 mmHg STANDARD_DEVIATION 11.3 • n=7 Participants	154 mmHg STANDARD_DEVIATION 11.1 • n=5 Participants
Baseline Diastolic Blood Pressure	85 mmHg STANDARD_DEVIATION 7.9 • n=5 Participants	86 mmHg STANDARD_DEVIATION 10.7 • n=7 Participants	86 mmHg STANDARD_DEVIATION 9.3 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Measure	Wet Cupping and Conventional Treatment n=40 Participants 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 n=40 Participants 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.
Systolic Blood Pressure After 4 Weeks	140 mmHg Standard Deviation 17.7	149 mmHg Standard Deviation 18.5

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Measure	Wet Cupping and Conventional Treatment n=40 Participants 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 n=40 Participants 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.
Diastolic Blood Pressure After 4 Weeks	82 mmHg Standard Deviation 9.9	81 mmHg Standard Deviation 12.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Wet Cupping and Conventional Treatment

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Conventional Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Wet Cupping and Conventional Treatment n=40 participants at risk 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 n=40 participants at risk 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.
General disorders Headache	25.0% 10/40 • Number of events 13 • 2 months	0.00% 0/40 • 2 months
General disorders Dizziness	15.0% 6/40 • Number of events 7 • 2 months	0.00% 0/40 • 2 months
Skin and subcutaneous tissue disorders Itching	20.0% 8/40 • Number of events 8 • 2 months	0.00% 0/40 • 2 months

Additional Information

Dr. Nouran Aleyeidi

Ministry of Health

Phone: 00966504304577

Email: dr.nouran@live.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place