Protocol summary
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Study aim
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The effect of nano-curcumin supplementation on respiratory capacity and serum IL-6 level in patients with stages 3 and 4 of chronic obstructive pulmonary disease
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Design
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A randomized, controlled, parallel groups, double-blind, placebo-controlled clinical trial
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Settings and conduct
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In this study, 60 participants from among the patients with chronic obstructive pulmonary disease (COPD) in the pulmonary ward of Imam Khomeini Hospital in Urmia, who are in the third and fourth stages of COPD in terms of the severity of the disease and the type of treatment, will be selected by observing the inclusion and exclusion criteria and then will be randomly divided into intervention and control groups. The control group will receive their common medical treatment and the placebo and the intervention group will receive a nano-curcumin capsule containing 80 mg of curcumin in the form of nano micelles daily in addition to their common medical treatment. Food intake, physical activity and the amount of tobacco consumption will be obtained by a questionnaire before and after the intervention. Also, the respiratory capacity, indicators related to the adequacy of the patients' lung function and the serum levels of interleukin 6 will be measured using spirometry and ELISA, respectively, before and after the intervention.
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Participants/Inclusion and exclusion criteria
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Adult age range (18-65 years). Smokers who have been smoking for at least 10 years. Confirmation of chronic pulmonary obstruction based on GOLD index.The patient has stages 3 and 4 of chronic pulmonary obstruction
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Intervention groups
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The intervention group will receive an oral nano-curcumin capsule containing 80 mg curcumin as a nano micelle daily for 3 months.
The control group will receive one placebo capsule daily (consisting of polysorbate, propylene glycol and distilled water) for 3 months.
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Main outcome variables
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FEV1/FEC; Interleukin-6
General information
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Reason for update
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To update the dosage of the supplement used and the variables studied
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191222045853N1
Registration date:
2020-02-06, 1398/11/17
Registration timing:
registered_while_recruiting
Last update:
2023-10-31, 1402/08/09
Update count:
2
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Registration date
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2020-02-06, 1398/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-21, 1398/11/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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2020-01-21, 1398/11/01
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Actual recruitment end date
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2020-09-22, 1399/07/01
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Trial completion date
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2020-09-22, 1399/07/01
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Scientific title
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Investigating the effect of nano-curcumin supplementation on ventilatory capacity, polmonary function indices and serum interleukin-6 of patients with stage 3 (severe) and 4 (very severe) chronic obstructive pulmonary disease
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Public title
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The effects of nano-curcumin on obstructive pulmonary disease patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
• Adult age range (18-65 years).
Smokers who have been smoking for at least 10 years.
Confirmation of chronic obstructive pulmonary disease according to GOLD criteria.
The patient has stages 3 and 4 of chronic pulmonary obstruction.
Exclusion criteria:
Patient with gallstones
Infectious diseases
Gastrointestinal problems such as malabsorption
Other chronic diseases (such as cancer, kidney disease, diabetes, etc.).
Long-term use of corticosteroid drugs and compounds, ie, more than 10 days of corticosteroid use per year.
Use of any anticoagulant drugs such as heparin, aspirin, clopidogrel, dipyridamole, warfarin and ticlopidine.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using the block randomization method. We have two case and control groups (C and T) that will have 6 models using 4 blocks (TTCC, TCTC, TCCT, CCTT, CTCT, CTTC). Subjects randomly will be assigned to case and control groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Using coding on supplements
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-07, 1397/09/16
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Ethics committee reference number
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IR.UMSU.REC.1398.295
Health conditions studied
1
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Description of health condition studied
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chronic obstructive pulmonary disease
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ICD-10 code
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J44.9
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ICD-10 code description
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Chronic obstructive pulmonary disease, unspecified
Primary outcomes
1
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Description
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Interleukin-6
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Timepoint
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beginning and end of supplementation
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Method of measurement
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ELISA
2
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Description
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spirometry
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Timepoint
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beginning and end of supplementation
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Method of measurement
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Spirometere
3
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Description
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Anthropometric measurements
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Timepoint
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beginning and end of supplementation
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Method of measurement
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Bioelectric impedance device
4
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Description
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Blood pressure
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Timepoint
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beginning and end of supplementation
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Method of measurement
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sphygmomanometer
5
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Description
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Dietary intake
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Timepoint
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beginning and end of supplementation
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Method of measurement
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Food record form
6
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Description
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Physical activity
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Timepoint
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beginning and end of supplementation
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Method of measurement
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international physical activity questionnaire
Intervention groups
1
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Description
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Intervention group: nano-curcumin supplement, one capsule daily, each capsule contains 80 mg of curcumin in the form of nanomicelles, for 12 weeks, consumed with food, produced by Sina company.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, one capsule daily, each capsule consists of polysorbate, propylene glycol and distilled water for 12 weeks, consumed with food, produced by Sina company.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Vice chancellor for research, Urmia University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available