1. Home
  2. Approved trials
  3. » فارسی

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

Protocol summary

Study aim
To evaluate the efficacy of nano-micellar curcumin supplementation on systemic inflammation and clinical symptoms in patients with ANCA-associated vasculitis.
Design
A randomized, double-blind, placebo-controlled clinical trial involving 45 patients with GPA, randomly allocated in a 1:1 ratio to nano-micellar curcumin (n=23) or placebo (n=22) for 3 months, in addition to standard treatment.
Settings and conduct
This is a randomized, double-blind, placebo-controlled clinical trial involving 45 patients with mild-to-moderate active granulomatosis with polyangiitis (GPA), conducted at the Rheumatology Clinics of Imam Reza Hospital and Ghaem Hospital in Mashhad, Iran. Participants will be randomly allocated in a 1:1 ratio to receive either nano-micellar curcumin (40 mg twice daily for 3 months) or matching placebo, in addition to standard treatment. The investigational product and placebo will be identical in appearance and coded. Participants, investigators, and outcome assessors will remain blinded to treatment allocation until completion of data analysis.
Participants/Inclusion and exclusion criteria
A randomized, double-blind, placebo-controlled clinical trial involving 45 patients with mild-to-moderate active GPA at Imam Reza and Ghaem Hospitals in Mashhad. Participants will be randomly allocated in a 1:1 ratio using blocks of four to receive nano-micellar curcumin 40 mg twice daily for 3 months (n=23) or placebo (n=22).
Intervention groups
Intervention group (n=23): Standard treatment + nano-micellar curcumin 40 mg twice daily for 3 months. Control group (n=22): Standard treatment + placebo, one capsule twice daily for 3 months.
Main outcome variables
Primary outcome: Serum IL-6 level Secondary outcomes: Prooxidant–antioxidant balance (PAB); disease activity assessed by the BVAS; quality of life assessed using the SF-36 questionnaire; and inflammatory markers, including ESR and CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191221045837N6
Registration date: 2026-08-22, 1405/05/31
Registration timing: prospective

Last update: 2026-08-22, 1405/05/31
Update count: 0
Registration date
2026-08-22, 1405/05/31
Registrant information
Name
Zinat Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1584
Email address
heidarizn@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2028-09-22, 1407/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Nano-Micellar Curcumin on ANCA-Associated Vasculitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Khorasan Razavi, Mashhad, Azadi Sq, Fcaulty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2026-06-20, 1405/03/30
Ethics committee reference number
IR.MUMS.REC.1405.094

Health conditions studied

1

Description of health condition studied
Granulomatosis with Polyangiitis (GPA)
ICD-10 code
M31.7
ICD-10 code description
Microscopic polyangiitis

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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.

2

Description
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.

3

Description
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.

4

Description
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.

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Educational, Research and Medical Complex
Full name of responsible person
Zinat Heidari
Street address
Razavi Khorasan Province, Mashhad, Ibn Sina Street, Imam Reza Hospital Square, Imam Reza Educational, Research and Medical Center.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3180 1536
Email
Heidarizn@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Educational Research and Treatment Center
Full name of responsible person
Zinat Heidari
Street address
Razavi Khorasan Province, Mashhad, Ahmadabad Street, Ghaem Hospital.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3180 1536
Email
heidarizn@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central department of Mashhad University of Medical Sciences, next to Alton Tower, Daneshgah Street, Mashhad, Khorasan Razavi Province, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
z.heidary.1989@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Deputy of Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Zinat Heidari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Khorasan Razavi, Mashhad, Azadi Sq, Fcaulty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Email
z.heidary.1989@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zinat Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Email
z.heidary.1989@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zinat Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Email
z.heidary.1989@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of study, all medical records of patients will be shared.
When the data will become available and for how long
The access period starts 6 months after the publication.
To whom data/document is available
Researchers affiliated to academic, scientific and industrial institutes
Under which criteria data/document could be used
No one is allowed to use the documents except the principal researcher.
From where data/document is obtainable
Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir
What processes are involved for a request to access data/document
Send an email to Dr. Zinat Heidari. heidarizn@mums.ac.ir
Comments
Loading...