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IRCT20220425054654N1 IRCT 2022-07-07 Iran's National Elites Foundation (INEF) Effects of wet cupping therapy in non-alcoholic fatty liver disease Investigation of the effects of wet cupping therapy on some inflammatory factors in patients affected by non-alcoholic fatty liver disease (NAFLD) 2021-04-03 anticipated 20 Complete https://irct.ir/trial/63179 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: A quasi-experimental trial study with self-controls. N/A Non-alcoholic fatty liver disease (NAFLD). 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.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Rezvan Najafi
Fahmideh St. 5th floor Hamadan Iran Research center for molecular medicine, Hamadan University of Medical Sciences
Hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3838 0583 najafi2535@gmail.com Hamedan University of Medical Sciences scientific Rezvan Najafi
Fahmideh St. 5th Floor Research center for molecular medicine, Hamadan University of Medical Sciences, Hamadan, Iran
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0583 najafi2535@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Both 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 ... K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other 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. 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). 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). 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). 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). 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. 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. Iran's National Elites Foundation (INEF) Approved 2021-07-03 Ethics Committee of the Faculty of Medicine, Hamadan University of Medical Sciences Fahmideh St. Research center for molecular medicine, Hamadan University of Medical Sciences, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)