]>
IRCT20191221045837N6 IRCT 2026-08-22 Mashhad University of Medical Sciences Effect of Nano-Micellar Curcumin on ANCA-Associated Vasculitis Evaluation of the Effects of Nanomicellar Curcumin Supplementation on Inflammatory Markers and Quality of Life in Patients with ANCA-Associated Vasculitis: A Randomized Controlled Clinical Trial 2026-09-23 anticipated 45 Recruiting https://irct.ir/trial/92689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method: A permuted block randomization method will be used to generate the allocation sequence, ensuring equal allocation of participants to the two study groups. The randomization sequence will be generated using the website www.randomization.com, Blinding description: To ensure allocation concealment, the investigational drug and placebo will be prepared by the pharmaceutical company in identical packaging with respect to appearance, color, size, and labeling, and will be coded. The group allocation codes will be kept by an individual outside the research team. The investigators, participants, and outcome assessors will remain blinded to the intervention assignment until completion of the data analysis. In the event of a medical emergency, the allocation code for the relevant participant may be unblinded. 2-3 Granulomatosis with Polyangiitis (GPA). Intervention 1: Intervention group: Participants in this group will receive nano-micellar curcumin 40 mg orally, one capsule twice daily for 3 months, in addition to standard treatment. The investigational product is SinaCurcumin, containing 40 mg of curcumin in a nano-micellar formulation. Intervention 2: Control group: Participants in this group will receive placebo orally, one capsule twice daily for 3 months, in addition to standard treatment. The placebo will be identical to the nano-micellar curcumin formulation in terms of appearance, color, size, and packaging. Yes - There is a plan to make this available What will be shared: At the end of study, all medical records of patients will be shared. When: The access period starts 6 months after the publication. To whom: Researchers affiliated to academic, scientific and industrial institutes Conditions: No one is allowed to use the documents except the principal researcher. Where to obtain: Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir How to obtain: Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir Comments:
public Zinat Heidari
Khorasan Razavi, Mashhad, Azadi Sq, Fcaulty of Pharmacy
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 z.heidary.1989@gmail.com Mashhad University of Medical Sciences scientific Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 z.heidary.1989@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmed diagnosis of Granulomatosis with Polyangiitis (GPA) based on the ACR/EULAR classification criteria and the 2012 Chapel Hill Consensus Conference nomenclature. Age: Patients aged 18–70 years.Disease activity: Newly diagnosed patients with active mild-to-moderate GPA (BVAS of 2–15) who require standard treatment. Standard treatment will include corticosteroids combined with conventional immunosuppressive agents used for mild-to-moderate disease, including methotrexate, azathioprine, or mycophenolate mofetil, according to the treating rheumatologist’s judgment and the patient’s clinical condition. Informed Consent: Willingness and ability of the patient to participate in the study and provide written informed consent. 18 years 70 years Both Known hypersensitivity or severe adverse reaction to curcumin or any component of the nano-micellar curcumin formulation. Presence of severe pre-existing comorbidities, including cardiovascular insufficiency/disorders requiring anticoagulant therapy; hepatic involvement, defined as elevated liver enzymes (AST or ALT) more than three times the upper limit of normal, evidence of advanced cirrhosis, hepatic failure, or Child–Pugh class B/C; or active malignancy. Pregnancy or breastfeeding at the time of study initiation. Use of curcumin-containing supplements within the previous 3 months. Use of other supplements or medications that substantially affect oxidative stress levels, such as high-dose vitamin E or vitamin C. M31.7 Microscopic polyangiitis Treatment - Drugs Placebo Intervention group: Participants in this group will receive nano-micellar curcumin 40 mg orally, one capsule twice daily for 3 months, in addition to standard treatment. The investigational product is SinaCurcumin, containing 40 mg of curcumin in a nano-micellar formulation. Control group: Participants in this group will receive placebo orally, one capsule twice daily for 3 months, in addition to standard treatment. The placebo will be identical to the nano-micellar curcumin formulation in terms of appearance, color, size, and packaging. Serum interleukin-6 (IL-6) level. Timepoint: At baseline and 3 months after initiation of curcumin supplementation (end of the study). Method of measurement: ELISA. Prooxidant–Antioxidant Balance (PAB): PAB will be assessed indirectly based on prooxidant and antioxidant markers. MDA will be measured as a prooxidant marker and TAC as an antioxidant marker. Timepoint: At baseline and 3 months after initiation of curcumin supplementation (end of the study). Method of measurement: Serum MDA will be measured using the TBARS assay, and total antioxidant capacity (TAC) will be assessed using a standard commercial assay kit. PAB will be evaluated based on the MDA and TAC results. Disease activity assessment using BVAS v3: Disease activity will be assessed using the Birmingham Vasculitis Activity Score (BVAS) version 3. Timepoint: At baseline and 3 months after initiation of curcumin supplementation (end of the study). Method of measurement: BVAS is a disease activity scoring system that assesses active organ involvement based on new or worsening clinical manifestations within the previous 4 weeks. The total score is recorded as the measure of disease activity. Quality of life assessment. Timepoint: At baseline and 3 months after initiation of curcumin supplementation (end of the study). Method of measurement: Health-related quality of life will be assessed using the SF-36 questionnaire, which evaluates eight functional domains. The validity and reliability of the Persian version of the SF-36 have been established in previous studies in Iran. Inflammatory marker assessment. Timepoint: At baseline and 3 months after initiation of curcumin supplementation (end of the study). Method of measurement: CRP will be measured using the ELISA method, and ESR will be measured using the Westergren method at baseline and at month 3. Research Deputy of Mashhad University of Medical Sciences Approved 2026-06-20 Ethics committee of Mashhad University of Medical Sciences Khorasan Razavi, Mashhad, Azadi Sq, Fcaulty of Pharmacy Mashhad Razavi Khorasan Iran (Islamic Republic of)