Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003557232399 Date of Approval: 13/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Wet and Dry Cupping Therapies on Selected Haematological and Immune System Parameters in Healthy Males in South Africa
Official scientific title The Effect of Wet and Dry Cupping Therapies on Selected Haematological and Immune System Parameters in Healthy Males in South Africa
Brief summary describing the background and objectives of the trial Cupping therapy has been studied, albeit inadequately, with respect to its efficacy in clinical conditions. However, investigation into its mechanism of action and influence on human physiology is lacking and recommended from the literature. There is a need to investigate and systematically document what parameters of human physiology it influences. The primary research problem is identifying possible physiological mechanism/s which cupping therapy influences (which in this study are haematological and immune system parameters). It has been used for thousands of years in many cultures to treat disease and maintain health. Its persistent use thorough the ages and in different cultures alludes to its possible beneficial effects. Physiological mechanisms by which it exerts its effects are neither documented nor well understood. The secondary research problem is the lack of evidence about the differences between wet and dry cupping. Currently it is unknown if they exert similar effects or if the added component of scarification and extravasation of blood actually adds a different effect. Wet and dry cupping are presently used for different conditions and are purported to have different effects. This has not been documented or quantified at present. The Overall Aim of This Study. To determine and compare the extent to which two different cupping techniques (wet and dry) modulate selected haematological and immune system parameters in healthy male participants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied The aim is to investigate the effects of wet and dry cupping on blood levels in normal people
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 03/03/2020
Actual trial start date
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IREC 12219 Durban University of Technology Institutional Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Wet Cupping therapy OR Dry Cupping Therapy A participant will receive EITHER wet cupping OR dry cupping as the first intervention in the first arm of the study. What intervention they receive first (wet OR dry) will be determined at random. The cupping intervention (wet or dry, which ever ONE of the two they have been allocated to) will be done once for 15 minutes. Venous blood will be drawn in 3 EDTA tubes before, after and 24 hours post intervention. Then after a wash out period of 15 days minimum. The very same participant will receive the opposite intervention to what they received first. Hence, if they received dry cupping first (which was determined at random on the first arm), they will now receive wet cupping the second arm of the study for 15 minutes. Venous blood will be drawn in 3 EDTA tubes before, after and 24 hours post intervention. Only ONE intervention will be done at a time (therefore EITHER wet cupping OR dry cupping, then AFTER 15 days minimum they will get the opposite of what they received first (if it was wet in the first arm of the study, they now get ONLY dry in the second arm of the study or vice versa). The cupping session lasts 15 minutes. Three cups are placed over the upper Trapezius area; one on the right above the scapular and the same for the one on the left and one in the midline just below the base of the neck. The mechanics of cupping involves the generation of a vacuum in a vessel (either of glass or perpex) (Michalsen et al. 2009). . The vacuum is generated by a hand pump which is inserted in a valve on the vessel and air is pumped out. Cupping can be either of two variants viz. “wet” or “dry”. In the former variant, blood is extravasated into a vessel within which the vacuum is generated, after tiny scarifications are made on the skin overlying the area of intervention (Mehta and Dhapte, 2015). In the latter variation, no scarifications are made; only a vessel within which a vacuum is generated is placed over the area of intervention (Mehta and Dhapte, 2015.) The area of intervention usually overlies or is near the location of disease or pain. It is most frequently done over the torso and mostly over the spinal region, but any region which as sufficient subcutaneous tissue, can be cupped (Bhikha and Haq, 2000). The vacuum pulls the skin and underlying tissue very strongly into the cup and the scarification on the skin in the “wet” variety, causes blood from the capillary bed to be extravasated into the cup due to the negative pressure. Frequently a small bruise is formed over the cupped area as a result of small surface capillaries breaking due to the strong negative pressure (Mehta and Dhapte, 2015; Bridgett et al. 2018). The two varieties of cupping appear similar in all respects except for the scarificaitons and extravasation of blood during wet cupping (Michalsen et al. 2009). During the wet cupping procedure, the scarifications will initiate the inflammatory and clotting cascades as this is akin to trauma, albeit minor (Baghdadi et al. 2015). To the knowledge of the researcher, there are no comparisons of the effects of dry cupping versus wet cupping in terms of the similarities and differences of their systemic effects. 30
Control Group Dry Cupping Therapy OR Wet Cupping Therapy A participant will receive EITHER wet cupping OR dry cupping as the first intervention in the first arm of the study. What intervention they receive first (wet OR dry) will be determined at random. The cupping intervention (wet or dry, which ever ONE of the two they have been allocated to) will be done once for 15 minutes. Venous blood will be drawn in 3 EDTA tubes before, after and 24 hours post intervention. Then after a wash out period of 15 days minimum. The very same participant will receive the opposite intervention to what they received first. Hence, if they received dry cupping first (which was determined at random on the first arm), they will now receive wet cupping the second arm of the study for 15 minutes. Venous blood will be drawn in 3 EDTA tubes before, after and 24 hours post intervention. Only one intervention will be done at a time (therefore EITHER wet cupping OR dry cupping, then AFTER 15 days minimum they will get the opposite of what they received first (if it was wet in the first arm of the study, they now get ONLY dry in the second arm of the study or vice versa). The cupping session lasts 15 minutes. Three cups are placed over the upper Trapezius area; one on the right above the scapular and the same for the one on the left and one in the midline just below the base of the neck. The mechanics of cupping involves the generation of a vacuum in a vessel (either of glass or perpex) (Michalsen et al. 2009). . The vacuum is generated by a hand pump which is inserted in a valve on the vessel and air is pumped out. Cupping can be either of two variants viz. “wet” or “dry”. In the former variant, blood is extravasated into a vessel within which the vacuum is generated, after tiny scarifications are made on the skin overlying the area of intervention (Mehta and Dhapte, 2015). In the latter variation, no scarifications are made; only a vessel within which a vacuum is generated is placed over the area of intervention (Mehta and Dhapte, 2015.) The area of intervention usually overlies or is near the location of disease or pain. It is most frequently done over the torso and mostly over the spinal region, but any region which as sufficient subcutaneous tissue, can be cupped (Bhikha and Haq, 2000). The vacuum pulls the skin and underlying tissue very strongly into the cup and the scarification on the skin in the “wet” variety, causes blood from the capillary bed to be extravasated into the cup due to the negative pressure. Frequently a small bruise is formed over the cupped area as a result of small surface capillaries breaking due to the strong negative pressure (Mehta and Dhapte, 2015; Bridgett et al. 2018). The two varieties of cupping appear similar in all respects except for the scarificaitons and extravasation of blood during wet cupping (Michalsen et al. 2009). During the wet cupping procedure, the scarifications will initiate the inflammatory and clotting cascades as this is akin to trauma, albeit minor (Baghdadi et al. 2015). To the knowledge of the researcher, there are no comparisons of the effects of dry cupping versus wet cupping in terms of the similarities and differences of their systemic effects. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: Any healthy male participant between 20-45 years of age, who resides in the eThekwini municipality for the duration of the study and who does not have any characteristics described under the exclusion criteria. For the purposes of this study a healthy male participants will be defined as having: 1. Normal blood pressure (Systolic pressure between 140mmHg and 120 mmHg and Diastolic pressure between 70mmHg and 90mmHg). This will be measured using a Welch Allen Sphygmomanometer on the left arm. 2. Heart Rate of between 50 beats per minute up to 90 beats per minute. This will be measured using manual palpation of radial pulse for 60 seconds. 3. Respiratory rate of between 12 breaths per minute and 25 breaths per minute. This will be measured by counting manually for 60 seconds. 4. Temperature (36.5°C to 37.3°C); average (37°C). This will be measured using a standard mercury oral thermometer. The above vital signs are the standard in classifying healthy participants in that any deviation from the normal ranges of blood pressure, heart rate, respiratory function or temperature can allude to systemic disease and the participant will therefore not be eligible to take part in the study (Pasqualetti et al. 2010; Gori, Breithaupt-Groegler et al. 2017). Exclusion Criteria: Any participant who has any of the following characteristics will not be included in the study. • Falls out of the age range (20-45) at their last birthday. • Has any known systemic illness which is active or dormant. • On anticoagulant or anti-platelet medication (Warfarin or Aspirin). • Has a bleeding disorder or blood dyscrasia. • Who is known to be anaemic due to any cause. • Who has had cupping therapy done (either dry or wet) within two months previous to the study. • Who declines consent and does not wish to follow-through with the study protocol. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 45 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/10/2019 Durban University of Technology Institutional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd Floor, Berwyn Court, Gate One, Steve Biko Campus, Steve Biko Road, Berea, Durban Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Full Blood Count, Erythrocyte Sedimentation Rate, C-Reactive Protein, Cortisol,Interleukin 6, Interleukin 10, Transforming Growth Factor Beta (TGF-β) and Tumour Necrosis Factor Alpha (TNF-α) Baseline, Immediately after intervention and 24 hours to 30 hours post-intervention
Primary Outcome Full Blood Count, Erythrocyte Sedimentation Rate, C-Reactive Protein, Cortisol,Interleukin 6, Interleukin 10, Transforming Growth Factor Beta (TGF-β) and Tumour Necrosis Factor Alpha (TNF-α) Baseline, Immediately post intervention and 24 hours to 30 hours post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Durban University of Technology Day Clinic Corner Ritson and Steve Biko Roads, Berea, Durban Durban 4000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Fund Meiring Naude Rd, Pretoria, Gauteng, Pretoria 0184 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Durban University of Technology Mansfield School Building, Steve Biko Campus, Steve Biko Road, Berea, Durban. Durban 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Suvarna Buldeo Neuberg-Global Laboratories, 11 Dan Pienaar Dr, Amanzimtoti, Durban, 4125 Amanzimtoti 4125 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aadil Docrat aadild@dut.ac.za +27829272361 Department of Chiropractic, Corner Ritson and Steve Biko Roads, Berea, Durban 4000
City Postal code Country Position/Affiliation
Durban 4000 South Africa Senior Lecturer at Durban University of Technology
Role Name Email Phone Street address
Scientific Enquiries Ashley Ross ashleyr@dut.ac.za +27313732542 Department of Homeopathy, Corner Ritson and Steve Biko Roads, Berea, Durban
City Postal code Country Position/Affiliation
Durban 4000 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Lavisha Deonarain lavishad@dut.ac.za +27313732375 2nd Floor, Berwyn Court, Gate One, Steve Biko Campus, Steve Biko Road, Berea, Durban
City Postal code Country Position/Affiliation
Durban 4000 South Africa Institutional Research Ethics Administrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data will be available on request by the participants. The final outcome of the study will be published in Thesis format and in Peer Reviewed Journals. The thesis will be available on the Durban University of Technology (DUT) Institutional Repository and journal articles will be available via the library database. While the Data Sharing Time Frame is 2 years from the termination of the study, as explained below; the raw data will be retained in a safe environment in the department of chiropractic research archives for a period of five years. After this period elapses the data will be destroyed by being shredded. Electronic data will be deleted permanently after the 5 year period elapses. The participants’ file will be coded which will ensure identification by means other than their names. None of the data will contain names or personal identifiers of any participant. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol These will be available at the end of the study which is anticipated to be end 2021. The sharing time frame will be 2 years from then till end 2023 (i.e 2 years) Access will be controlled. The DUT Institutional Research Ethics Committee (IREC) will entertain requests and approve accordingly. Requests can only be entertained from bona fide academic institutions and only on presentation of a valid ethics clearance number and certificate to the DUT IREC from the requesting institution.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://library.dut.ac.za/ OR http://openscholar.dut.ac.za/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information