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IRCT20121031011341N11 IRCT 2023-02-25 Shiraz University of Medical Sciences The efficacy of Fumaria parviflora L. versus gabapentin on pruritus of patients undergoing hemodialysis The efficacy of Fumaria parviflora L. versus gabapentin on uremic pruritus of patients undergoing hemodialysis: A randomized non-inferiority double-blinded active-controlled clinical trial 2023-03-06 anticipated 70 Complete https://irct.ir/trial/66814 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using stratified block randomization method with unequal blocks (4,6,8). Block random sequence will be created using random sequence generator software. The sequence of allocation blocks will be random. The random allocation ratio will be 1:1, so that for each control, one active case will be present in the study. Based on the randomly generated sequence, each drug/placebo package will be identified with a unique code, Blinding description: Gabapentin, F. parviflora, and their placebo capsules have the same color, shape, and size. Their container will be labeled by a coordinator (not included in the study team) with nonidentifiable codes. Regarding groups assignment, participants, investigators, caregivers, and data analyzers will be blinded. 3 Uremic prururitus in dialysis patient. Intervention 1: first intervention group: the patients in this group are given 2 grams of Fumaria parviflora L. in the form of 6 capsules of 330 mg as two capsules three times a day and one placebo capsule is given to them at night. Intervention 2: second intervention group: patients in this group are given one capsule of 100 mg of gabapentin at night before going to bed, as well as two placebo capsules three times a day. 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 Hosseini Seyed Ali
Namazi hospital, Namazi square, Zand Blvd
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4332 hoseiniseyyedali70@gmail.com Shiraz University of Medical Sciences scientific Mohammad Hashem Hashempur
Zand Blvd
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4332 hashempur@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The hemodialysis patient who has uncontrollable pruritus and now at least 1 week doesn't use any antipruritus medication who had pruritus for at least 6 weeks patient must have normal range phosphor and potassium in the past month Parathyroid Hormone (PTH) must be lower than 500 measured visual analogue scale (VAS) score must be four or more 18 years 60 years Both They do not have liver disease, a history of convulsions, or a specific skin disease that causes itching, and they do not have hemolytic blood disease. Patients who complain of itching for the first time are not included in the study If the patient was taking medication that interacted with gabapentin or Fumaria parviflora L., he was not included in the study Those who are allergic to Fumaria parviflora L. or Gabapentin are not included in the study L29 Pruritus Treatment - Drugs Treatment - Drugs first intervention group: the patients in this group are given 2 grams of Fumaria parviflora L. in the form of 6 capsules of 330 mg as two capsules three times a day and one placebo capsule is given to them at night second intervention group: patients in this group are given one capsule of 100 mg of gabapentin at night before going to bed, as well as two placebo capsules three times a day Itching score in the 5-D pruritus questionnaire. Timepoint: Before the start of the intervention (the beginning of the study) and two months later (the end of the study). Method of measurement: 5D itch questionnaire. Quality of life score in DLQI questionnaire. Timepoint: Before the start of the intervention (the beginning of the study) and two months later (the end of the study). Method of measurement: DLQI quality of life questionnaire. Shiraz University of Medical Sciences Approved 2022-11-05 Shiraz University of Medical Sciences Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences, Zand street, Shiraz, Iran. Shiraz Fars Iran (Islamic Republic of)