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IRCT20191221045837N2 IRCT 2020-10-16 Mashhad University of Medical Sciences Effect of Nanomicelle Curcumin in Ulcerative Colitis Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Ulcerative Colitis (UC) 2020-10-22 anticipated 40 Complete https://irct.ir/trial/50034 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization method: Block randomization:This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization Randomization unit: individual Randomization tool: https://www.sealedenvelope.com/ How to make a random sequence: For this method, the size of each block must first be specified (for example, a quadruple block). Then write a list of blocks and assign numbers to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers between one and 6 (Eg 1 4 5, etc.) and finally specify the treatment allocation list based on previous random numbers (… AABB-BBAA-BABA-) In this study, we use 4 blocks and the site https://www.sealedenvelope.com randomizes and numbers the blocks. Allocation Concealment Method: Sealed Envelopes, Blinding description: The study is three-way blind in which the subjects, evaluators, analysts, sample allocators will be unaware of the intervention and control groups. Drugs and placebo, numbered 1-40, will be identified and distinguished by the drug manufacturing company, which belong to the drug or placebo group based on a random list prepared from www.sealedenvelope.com. The physician, patients, and analyst will remain unaware of the type of formulation until the work is completed. Patients receive one of the medicine containers, number 1-40, from the pharmacy student, respectively. The list will be decrypted when completed. 2-3 Children with Ulcerative Colitis (UC). Intervention 1: Control group : In addition to the standard treatment (sulfasalazine), a volume equivalent of placebo syrup will be given daily for two months. Intervention 2: Intervention group: In addition to standard treatment (sulfasalazine), curcumin syrup at a dose of 40 mg daily will be prescribed for two months. Due to the lipophilic nature of curcumin, the oral absorption of curcumin in common oral forms (powder, capsules and tablets) is very low. However, in Sina-Curcumin (manufactured by Exir Nano Sina Company), all curcumin is trapped in the hydrophobic part of curcumin nanoparticles. These spherical nano-micels have a particle size of about 10 nanometers and increase the solubility of curcumin in water. After oral administration, soft gel capsules containing curcumin nano-micels are dispersed in the acidic environment of the open stomach in less than 15 minutes. These nano-micels are stable in the acidic environment of the stomach for at least 6 hours and do not die and reach the small intestine intact. Once in the small intestine, the nano-micels facilitate the transfer of curcumin from the intact water layer on the surface of intestinal epithelial cells, which is a barrier to the absorption of fat-soluble compounds and increase the absorption of curcumin orally. Yes - There is a plan to make this available What will be shared: After the end of the study and data collection and data transfer to SPSS software, all patient data can be shared after unidentified individuals. When: Access period starts 6 months after the results are published To whom: Researchers working in academic, scientific and industrial institutes Conditions: No one is allowed to use the documents except the principal investigator. Where to obtain: Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir How to obtain: Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir Comments:
public Zinat Heidari
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1584 heidarizn@mums.ac.ir 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 heidarizn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children 6-18 years old who , according to the ESPHAN Guideline , have mild to moderate active Ulcerative Colitis Obtain informed consent from the patient/ patient's parents 6 years 18 years Both Child with a history of underlying disease including heart, kidney, liver, biliary, gastrointestinal diseases (any gastrointestinal disease other than UC) simultaneously Taking anticoagulants such as warfarin or antiplatelet drugs by the patient Diabetic patients K51 Ulcerative colitis Placebo Treatment - Drugs Control group : In addition to the standard treatment (sulfasalazine), a volume equivalent of placebo syrup will be given daily for two months. Intervention group: In addition to standard treatment (sulfasalazine), curcumin syrup at a dose of 40 mg daily will be prescribed for two months. Due to the lipophilic nature of curcumin, the oral absorption of curcumin in common oral forms (powder, capsules and tablets) is very low. However, in Sina-Curcumin (manufactured by Exir Nano Sina Company), all curcumin is trapped in the hydrophobic part of curcumin nanoparticles. These spherical nano-micels have a particle size of about 10 nanometers and increase the solubility of curcumin in water. After oral administration, soft gel capsules containing curcumin nano-micels are dispersed in the acidic environment of the open stomach in less than 15 minutes. These nano-micels are stable in the acidic environment of the stomach for at least 6 hours and do not die and reach the small intestine intact. Once in the small intestine, the nano-micels facilitate the transfer of curcumin from the intact water layer on the surface of intestinal epithelial cells, which is a barrier to the absorption of fat-soluble compounds and increase the absorption of curcumin orally. The Pediatric Ulcerative Colitis Activity Index (PUCAI). Timepoint: Assess the severity of the disease at baseline, at the end of the first month and at the end of the second month of treatment. Method of measurement: Stool exam and PUCAI questionnaires. The Simple Clinical Colitis Activity Index (CSCCAI). Timepoint: Assess the severity of the disease at baseline, at the end of the first month and at the end of the second month of treatment. Method of measurement: Stool exam and CSCCAI questionnaires. Mashhad University of Medical Sciences Approved 2019-11-23 Ethics committee of Mashhad University of Medical Sciences Razavi Khorasan Province, Mashhad, Daneshgah Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)