Effect of curcumin on patients with idiopathic chronic urticaria: a triple blind clinical trial

Determining the effect of curcumin drug on controlling the symptoms of patients with chronic idiopathic urticaria (reducing the total score of symptoms)

Clinical trial with control group ,parallel groups, triple blind, randomized, phase 3, on 106 patients. The rand function of Excel software is used for randomization.

In Sanandaj city, Dr. Rasul Nasir Karmarzi's office conducts a study using two groups: intervention and control. Both groups take either a placebo or curcumin pill daily for three months alongside routine treatment, with potential continuation of only routine treatment, for another three months (if needed).Both groups will be followed up for up to six months and Symptom severity is assessed weekly using a checklist with scoring from 0 to 3 for each outcome(total:18).The score of each week is obtained by adding up the scores of these 6 outcomes. Data collection involves a checklist and phone calls, with blinding of researchers, participants, caregivers, assessors, and analysts.

Inclusion criteria: patients (male/female) aged 18 to 60 years with chronic idiopathic urticaria. Exclusion criteria: having underlying diseases, allergy to turmeric, obstruction of the gallbladder duct, gastric ulcer, use of anticoagulant and antiplatelet drugs, Blood sugar reducing drugs. patients who have received previous urticaria treatment after relapse, pregnancy

Control group: usual treatment for urticaria plus placebo pill once a day for three months every day،Intervention group: usual treatment for urticaria + one curcumin tablet per day for three months every day

The number and size of the urticaria, the intensity of itching, the repetition and duration of symptoms, the frequency of needing to take antihistamines

Randomization in this study will be done in the form of simple randomization using the randbetween command in Excel software. At first, each person will be assigned a unique code (including two numbers and one English letter) and then randomization with The relevant command is used in the mentioned software. 53 first selections will be considered as intervention group and 53 second selections will be considered as comparison group. In order to establish allocation concealment, sealed envelopes are prepared and assigned codes in Sealed envelopes are placed. With this method, the person responsible for providing the intervention cannot recognize the randomization sequence and will also be unaware of which of the people will be in the intervention or comparison group.

In this study, all the patients participating in the study, all the people who are responsible for collecting data and evaluating the results over time, the attending physician, treatment personnel, data analysts, clinical caregivers, were kept blind to the allocation of the study groups. The only person who does not participate in any of the above roles and also the supervisor appointed through the ethics committee of the Kurdistan University of Medical Sciences is aware of the allocation of groups.In coordination with the Dina company, placebo and curcumin are both in the form of tablets with the same color, shape, size and all the appearance characteristics and are indistinguishable from each other. The packaging is also completely similar. The only difference is the presence of the letter A or B on the label

According to the request for a reasonable reason, the data that is not related to the personal information of the participants and has not been published directly will be provided to the researchers.(All individual participant data is potentially shareable after de-identification. The statistical analysis plan of the informed consent form and the clinical study report will be published in full.)

. 3 months after the publication of study results

Researchers working in academic and scientific institutions

.Any use or analysis of the data must be done in coordination with the responsible author and after his approval

Researchers can request documents or data files by sending an email to the person responsible for the scientific responsibility of the study. The exact response time is not known. The email and details of the person responsible for answering are mentioned in detail in the previous sections.

First, the researchers send an e-mail to the person responsible for the scientific response and specify which of the data they want. The information (except for the personal information of the participants) will be available to the said person after reviewing the request through e-mail.

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