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Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Ulcerative Colitis (UC)

Protocol summary

Study aim
Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Ulcerative Colitis (UC)
Design
A clinical trial with a control group, with parallel groups, three-way blind, randomized, phase 2 on 40 patients, www.randomization.com was used for randomization.
Settings and conduct
This study includes intervention and control groups. In addition to receiving standard treatment(based on the severity of the disease and according to the instructions of ESPGHAN Guideline) (sulfasalazine), patients in the control group will be given a volume equivalent of placebo syrup and in the intervention group curcumin syrup at a dose of 40 mg/d for 2 months. The study is performed in Akbar Children's Hospital in Mashhad The study is three-way blind: the subjects, evaluators, analysts, sample allocators to the groups.
Participants/Inclusion and exclusion criteria
Entry conditions: All children aged 6-18 years referred to Akbar Hospital Gastroenterology Clinic, who have been diagnosed with mild to moderate severity according to ESPGHAN Guideline criteria, obtain informed consent of the patient / patient's parents. Non-entry conditions: child with a history of underlying disease including heart, kidney, liver, biliary, gastrointestinal diseases (any disease Gastrointestinal other than UC) Concomitant use of anticoagulants such as warfarin or antiplatelet drugs by the patient, diabetics
Intervention groups
In addition to receiving standard treatment (sulfasalazine), patients in the control group will be given a volume equivalent of placebo syrup and in the intervention group curcumin syrup at a dose of 40 mg/d for 2 months.
Main outcome variables
Check the Pediatric Ulcerative Colitis Activity Index, the Simple Clinical Colitis Activity Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191221045837N2
Registration date: 2020-10-16, 1399/07/25
Registration timing: prospective

Last update: 2020-10-16, 1399/07/25
Update count: 0
Registration date
2020-10-16, 1399/07/25
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
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Nanomicelle Curcumin Formulation in Children with Ulcerative Colitis (UC)
Public title
Effect of Nanomicelle Curcumin in Ulcerative Colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 6 years old to 18 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: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
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
Razavi Khorasan Province, Mashhad, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.MUMS.REC.1398.253

Health conditions studied

1

Description of health condition studied
Children with Ulcerative Colitis (UC)
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
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

2

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
Control group : In addition to the standard treatment (sulfasalazine), a volume equivalent of placebo syrup will be given daily for two months.
Category
Placebo

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar pediatric hospital
Full name of responsible person
Zinat Heidari
Street address
Akbar pediatric hospital, Shahid Kaveh Boulevard, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
ak.pr@mums.ac.ir
Web page address
https://akbar.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
Razavi Khorasan Province, Mashhad, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Faculty of Pharmacy, University Campus, Azadi Square, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1584
Fax
Email
heidarizn@mums.ac.ir

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
Fax
Email
heidarizn@mums.ac.ir

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
Fax
Email
heidarizn@mums.ac.ir

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
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 the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic, scientific and industrial institutes
Under which criteria data/document could be used
No one is allowed to use the documents except the principal investigator.
From where data/document is obtainable
Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir
What processes are involved for a request to access data/document
Send an email to Dr. Zeinat Heydari. heidarizn@mums.ac.ir
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