Protocol summary

Study aim
Determining effect of curcumin-piperine drug on Pseudomonas infection and clinical symptoms of cystic fibrosis patients
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized,
Settings and conduct
Study population is the patients referred to the cystic fibrosis clinic in Akbar Children's Hospital. Patients are divided into case and control groups. Curcumin-piperine is given to case group and placebo with the usual treatments is given to control group . The duration of the treatment period will be 3 months. The results will be checked at the beginning and end of the treatment.
Participants/Inclusion and exclusion criteria
Entry conditions: Cystic fibrosis patients who have been diagnosed based on clinical symptoms and sweat test, 5 years and above, Have pulmonary and gastrointestinal problems, able to perform the spirometry maneuver and have at least FEV1≥ 30% based on normal population based on age, gender,height, Percentage of oxygen saturation based on pulse oximetry be≥90% at room temperature,be clinically stable, Informed consent has been obtained from the patients,Do not have heart,liver,kidney failure, Do not have celiac disease, No evidence of acute pulmonary exacerbation that requiring hospitalization in last4 weeks, Do not have evidence of severe complications of pulmonary disease including severe hemoptysis or pneumothorax during last 2 months
Intervention groups
Intervention group: the intervention group are cystic fibrosis patients with pseudomonas infection who are treated with curcumin-piperine in addition to the usual treatments for cystic fibrosis.control group are patients with cystic fibrosis who are treated with placebo in addition to the usual treatments of cystic fibrosis.
Main outcome variables
Clinical symptoms of patients,Pulmonary symptoms,Pseudomonas pulmonary infection,Weight,Height,Body mass index,Patients' quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221229056976N1
Registration date: 2023-01-26, 1401/11/06
Registration timing: prospective

Last update: 2023-01-26, 1401/11/06
Update count: 0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
Rasool Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4334 9745
Email address
reysoolmdi1376@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2024-03-04, 1402/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of curcumin-piperine in reducing Pseudomonas infection and improving clinical outcome in patients with cystic fibrosis
Public title
Evaluation of the effects of curcumin-piperine in reducing Pseudomonas infection and improving clinical outcome in patients with cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cystic fibrosis patients who have been diagnosed based on clinical symptoms and sweat test. 5 years and above. Have pulmonary and gastrointestinal problems. able to perform the spirometry maneuver and have at least FEV1 greater than or equal to 30% based on the normal population based on age, gender and height. The percentage of oxygen saturation based on pulse oximetry should be greater than or equal to 90% at room temperature. be clinically stable. Informed consent has been obtained from the patients. Do not have heart, liver or kidney failure. Do not have celiac disease. No evidence of acute pulmonary exacerbation that requiring hospitalization in last past 4 weeks. Do not have evidence of severe complications of pulmonary disease including severe hemoptysis or pneumothorax during the last 2 months.
Exclusion criteria:
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by random block method with blocks of 4 and using random numbers table of SAS software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The allocation ratio of the samples will be (Allocation 1:1) and will be placed in two groups (Assignment). Then, based on the obtained blocks and according to the allocation sequence, the drugs will be given to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the participants, a placebo will be used with packaging, color, size and other appearance characteristics completely similar to curcumin-piperine tablets. In order to blind the evaluators of the research team, as soon as the treatment or control group is determined in the randomization stage, a random code will be assigned to the participant (without including group A or B on the file) and they will be followed by this code in any stage of research. Finally, after evaluating and documenting the results ,the codes will be decoded.
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
Shahid Fakouri Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.512

Health conditions studied

1

Description of health condition studied
cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

Primary outcomes

1

Description
Evaluation of clinical symptoms of patients
Timepoint
In each visit
Method of measurement
Based on Shwachman-Kulczycki Score

2

Description
Evaluation of pulmonary symptoms
Timepoint
Every 3 to 6 months
Method of measurement
Based on spirometry

3

Description
Evaluation of Pseudomonas pulmonary infection
Timepoint
Every 3 months
Method of measurement
With nasopharyngeal swab sample (sputum culture and colony count)

4

Description
Weight
Timepoint
In each visit
Method of measurement
Weighing scale

5

Description
Height
Timepoint
In each visit
Method of measurement
Meter

6

Description
Body mass index (BMI)
Timepoint
In each visit
Method of measurement
Body weight (kg) divided by the square of the body height(m)

7

Description
Evaluation of patients' quality of life
Timepoint
Yearly
Method of measurement
Based on the quality of life questionnaire of cystic fibrosis patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention group are cystic fibrosis patients with pseudomonas infection who are treated with curcumin-piperine in addition to the usual treatments for cystic fibrosis. The duration of the treatment period will be 3 months. Curcumin-piperine is prepared in the form of 500 mg capsules with 5 mg of piperine as an absorption enhancer (Sami Labs Ltd., India) and is given to cystic fibrosis patients along with the usual treatments.
Category
Treatment - Drugs

2

Description
Control group: The control group are patients with cystic fibrosis who are treated with placebo in addition to the usual treatments of cystic fibrosis. placebo tablets containing microcrystalline cellulose matched in size, shape and color to the curcuminoids tablets
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Dr. Saeedeh Talebi
Street address
Kaveh Blvd, Region 9, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
ak.pr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3853 7590
Email
ghayourm@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
Saeedeh Talebi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital,Kaveh Blvd, Region 9, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
Talebis@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Talebi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital,Kaveh Blvd, Region 9, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
Talebis@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Talebi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital,Kaveh Blvd, Region 9, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
Talebis@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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