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IRCT20160713028901N8 IRCT 2026-06-22 Esfahan University of Medical Sciences Terminalia chebula extract in preventing nephrotoxicity Evaluation of Terminalia chebula extract in preventing contrast media-induced nephrotoxicity 2026-07-23 anticipated 86 Recruiting https://irct.ir/trial/90994 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random sequence generation will be performed using block randomization with variable block sizes. The randomization sequence will be generated using the Randomization.com software. Block sizes will vary randomly between 6 and 9 to prevent predictability of allocation. The sequences will be placed in sealed, numbered envelopes, and treatment allocation will be determined based on the order of patient enrollment. 3 Nephrotoxicity. Intervention 1: Intervention group: All patients will be hydrated before receiving the contrast agent according to the center's guidelines and protocol, as 1 mL/kg/hour of normal saline for 6 to 12 hours before receiving the contrast agent and 1 mL/kg/hour of normal saline for 6 to 12 hours during and after receiving the contrast agent. For the intervention group, 1000 mg of Helilah extract (two capsules) every 12 hours, starting 6 hours before the contrast agent injection for the patient and continuing for 3 days until the contrast agent is completely excreted from the patient. Intervention 2: Control group: All patients will be hydrated before receiving the contrast agent according to the center's guidelines and protocol, as 1 mL/kg/hour of normal saline for 6 to 12 hours before receiving the contrast agent and 1 mL/kg/hour of normal saline for 6 to 12 hours during and after receiving the contrast agent. The control group will not receive any medication other than the center's standard protocol. Yes - There is a plan to make this available What will be shared: Initially, both inpatients and outpatients will be included in the study; medication will be administered in the hospital for inpatients and at home for outpatients. In both groups of patients, if testing and follow-up are not possible by the third day, the patient will be excluded from the study. As mentioned in the objectives, urine output will be measured only in inpatients. When: The start of the data access period will be in October 2027, after the defense of the thesis and the publication of the article resulting from the project. To whom: Researchers, students and teachers working in academic and medical institutions Conditions: In order to design similar studies or use the results of this study for systematic review and meta-analysis of data Where to obtain: Online scientific databases, including PubMed, Web of Science, Scopus, and... Website of Central Library of Isfahan University of Medical Sciences, address: https://diglib.mui.ac.ir/ or by sending an email to the corresponding author: badri@pharm.mui.ac.ir How to obtain: Searching with keywords in scientific internet databases, Search through the title of the project on the website of the digital library of Isfahan University of Medical Sciences. Internet search on the website of the magazine where the article from the project is published Comments:
public Shirinsadat Badri
Hezar jarib street, Isfahan, iran.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7068 badri@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Shirinsadat Badri
Hezar jarib street, Isfahan, iran.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7068 badri@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years Received iodinated contrast agent eGFR over 60 (using CKD-EPI formula) 18 years 65 years Both Age over 65 years Concomitant administration of other nephrotoxic drugs (e.g. vancomycin, aminoglycosides, amphotericin-B, colistin, cisplatin, calcineurin inhibitors) Failure to complete the study by the end of the third day Pregnancy and lactation N17.9 Acute kidney failure, unspecified Prevention Prevention Intervention group: All patients will be hydrated before receiving the contrast agent according to the center's guidelines and protocol, as 1 mL/kg/hour of normal saline for 6 to 12 hours before receiving the contrast agent and 1 mL/kg/hour of normal saline for 6 to 12 hours during and after receiving the contrast agent. For the intervention group, 1000 mg of Helilah extract (two capsules) every 12 hours, starting 6 hours before the contrast agent injection for the patient and continuing for 3 days until the contrast agent is completely excreted from the patient. Control group: All patients will be hydrated before receiving the contrast agent according to the center's guidelines and protocol, as 1 mL/kg/hour of normal saline for 6 to 12 hours before receiving the contrast agent and 1 mL/kg/hour of normal saline for 6 to 12 hours during and after receiving the contrast agent. The control group will not receive any medication other than the center's standard protocol. EGFR changes. Timepoint: At baseline and at the end of treatment (after 72 hours). Method of measurement: Calculation with the CKD-EPI formula. Changes in creatinine serum level. Timepoint: At baseline and at the end of treatment (after 72 hours). Method of measurement: measuring creatinine level in serum sample. Changes in BUN level. Timepoint: At baseline and at the end of treatment (after 72 hours). Method of measurement: measuring BUN level in blood sample. Changes in urine output. Timepoint: At baseline and at the end of treatment (after 72 hours). Method of measurement: measuring urine volume. Esfahan University of Medical Sciences Approved 2026-04-05 Research Ethics Committee of the Faculties of Pharmacy and Nutrition -Isfahan University of Medical Isfahan University of Medical Sciences and Health Services, Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)