Assessing the effects of wet cupping therapy on some inflammatory cytokines pre- and post-treatment such as hs-CRP\ IL-6 \ IL-1β \ TNF-α
Assessing the hemological and biochemical modifications pre- and post-treatment on lipid profile and liver enzymes
Design
A quasi-experimental trial study with self-controls on 20 patients
Settings and conduct
This quasi-experimental trial study with self-controls is conducted on 20 study subjects selected in Omid Clinic in Hamadan- Iran according to our criteria inclusion through medical examinations by our experts in Iranian Medicine
Participants/Inclusion and exclusion criteria
Men and women from 20- to 60-year-old affected by non alcoholic fatty liver disease grade II and III proved by ultrasonography of the liver, with or without alteration in their liver enzymes are included in the study.
Patients who were affected by other chronic liver diseases or hepatitis and anemia; also heavy smokers, alcohol drinkers and patients with prolonged intake of drugs induced fatty liver diseases are excluded from the study.
Intervention groups
Wet cupping therapy every 15 days for a total of three times on all patients
Main outcome variables
Modifications on inflammatory cytokines such as hs-CRP / IL-1β / IL-6 / TNF-α
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220425054654N1
Registration date:2022-07-07, 1401/04/16
Registration timing:retrospective
Last update:2022-07-07, 1401/04/16
Update count:0
Registration date
2022-07-07, 1401/04/16
Registrant information
Name
Nooshin Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0583
Email address
dr.nooshin.abbasi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-08-05, 1400/05/14
Actual recruitment start date
2021-07-06, 1400/04/15
Actual recruitment end date
2021-11-13, 1400/08/22
Trial completion date
2021-12-18, 1400/09/27
Scientific title
Investigation of the effects of wet cupping therapy on some inflammatory factors in patients affected by non-alcoholic fatty liver disease (NAFLD)
Public title
Effects of wet cupping therapy in non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women affected by non alcoholic fatty liver disease grade II and III proved by ultrasonography of the liver
NAFLD patients with or without alteration in their liver enzymes
Exclusion criteria:
Patients who were affected by other chronic liver diseases or hepatitis and anemia
Heavy smokers
Alcohol drinkers with intake greater than 2 alcohol units (20 g/day) for women and greater than three alcohol units (30 g/day) for men
Patients with prolonged intake of drugs induced fatty liver diseases such as amiodarone, perhexiline, DH, steroid hormones, tamoxifen and ...
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
A quasi-experimental trial study with self-controls
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Hamadan University of Medical Sciences
Street address
Fahmideh St. Research center for molecular medicine, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.UMSHA.REC.1400.291
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Modification on inflammatory cytokine Tumor Necrosis Factor-α (TNF-α)
Timepoint
Measuring the level of inflammatory cytokine Tumor Necrosis Factor-α (TNF-α) at the beginning of the study (before intervention) and after 48 hours of each wet cupping. Wet cupping therapy was applied once every 15 days for a total of three times
Method of measurement
Enzyme-linked immunosorbent quantitative assay (ELISA) kit is used to measure the modification level of inflammatory cytokine Tumor Necrosis Factor-α (TNF-α).
2
Description
Modification on inflammatory cytokine Interleukin-1β (IL-1β)
Timepoint
Measuring the level of inflammatory cytokine Interleukin-1β (IL-1β) at the beginning of the study (before intervention) and after 48 hours of each wet cupping. Wet cupping therapy was applied once every 15 days for a total of three times
Method of measurement
Enzyme-linked immunosorbent quantitative assay (ELISA) kit is used to measure the modification level of inflammatory cytokine Interleukin-1β (IL-1β).
3
Description
Modification on inflammatory cytokine Interleukin-6 (IL-6)
Timepoint
Measuring the level of inflammatory cytokineInterleukin-6 (IL-6) at the beginning of the study (before intervention) and after 48 hours of each wet cupping. Wet cupping therapy was applied once every 15 days for a total of three times
Method of measurement
Enzyme-linked immunosorbent quantitative assay (ELISA) kit is used to measure the modification level of inflammatory cytokine Interleukin-6 (IL-6).
4
Description
Modification on High sensitivity C-reactive protein (hs-CRP) level
Timepoint
Measuring the level of High sensitivity C-reactive protein (hs-CRP) at the beginning of the study (before intervention) and after 48 hours of the last wet cupping (third wet cupping). Wet cupping therapy was applied once every 15 days for a total of three times
Method of measurement
High sensitivity C-reactive protein was measured by CRP detection kit (Nephelometry)
Secondary outcomes
1
Description
serum lipids' level
Timepoint
Measuring the level of reduction on serum lipid profile at the beginning of the study (before intervention) and after 48 hours of last wet cupping. Wet cupping therapy was applied once every 15 days for a total of three times
Method of measurement
The reduction of serum lipid profile low-density lipoprotein- cholesterol (LDL-C) and high-density lipoprotein- cholesterol was measured by quantitative kit.
2
Description
liver enzymes' level
Timepoint
Measuring the level of reduction on modifying liver enzymes' profile at the beginning of the study (before intervention) and after 48 hours of last wet cupping. Wet cupping therapy was applied once every 15 days for a total of three times
Method of measurement
The modification of liver enzymes' profile alanine transaminase (ALT) and aspartate aminotransferase (AST) was measured by activity assay kit.
Intervention groups
1
Description
Intervention group: wet cupping therapy was done on all patients in an only group, which was our control group, once every 15 days for a total of three times. Patients sit cross-legged on the bed. The intrascapular area, brown adipose tissue, was disinfected and suctioned through negative pressure created by a vacuumed cup connected to a suction device. Then the skin under the cup area was scarified with multiple superficial oblique scratches, and blood flown into the cup following the second suction. The cup was removed and the extracted blood was gently cleaned from the skin surface. The suction and extracting capillary blood were repeated three times on the same site. Finally, the location of cupping was cleaned and covered by a layer of honey and a sterile gauze was fixed on it with surgical tapes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center for molecular medicine, Hamadan University of Medical Sciences
Full name of responsible person
Rezvan Najafi
Street address
Fahmideh St. 5th floor Research center for molecular medicine, Hamadan University of Medical Sciences Hamadan Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0583
Fax
+98 81 3838 0583
Email
najafi2535@gmail.com
Web page address
https://www.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran's National Elites Foundation (INEF)
Full name of responsible person
Meisam Noori
Street address
No.209 Azadi St., between Navvab St. and Roodaki St., at the corner of Tahernia lane, Tehran
City
Tehran
Province
Tehran
Postal code
9313117578
Phone
+98 21 6347 8000
Fax
+98 21 6691 7166
Email
m.nouri@basu.ac.ir
Web page address
https://www.bmn.ir/
Grant name
Iran's National Elites Foundation (INEF). Iranian cooperation postdoctoral program for oversees specialists
Grant code / Reference number
11/61788
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran's National Elites Foundation (INEF)
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rezvan Najafi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Fahmideh St. 5th floor Hamadan Iran Research center for molecular medicine, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 0583
Fax
+98 81 3838 0583
Email
najafi2535@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rezvan Najafi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Fahmideh St. 5th Floor Research center for molecular medicine, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0583
Fax
+98 81 3838 0583
Email
najafi2535@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rezvan Najafi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Fahmideh St. 5th floor Hamadan Iran Research center for molecular medicine, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0583
Fax
+98 81 3838 0583
Email
najafi2535@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available