Investigating the effect of curcumin supplementatin on ventilatory capacity, polmonary function indices and serum interleukin-6 of patients with stage 3 (severe) and 4 (very severe) chronic obstructive pulmonary disease
The effect of curcumin supplementation on respiratory capacity and serum IL-6 level in patients with stages 3 and 4 of chronic obstructive pulmonary disease
Design
A randomized, controlled, parallel groups, double-blind, placebo-controlled clinical trial
Settings and conduct
In this study 60 participants with chronic pulmonary obstructive pulmonary disease admitted in Imam Khomeini Hospital, Urmia, Iran, who were in the third and fourth stage of chronic obstructive pulmonary disease according to inclusion criteria, were enrolled. They were selected and randomly divided into intervention and control groups. The control group received their usual medical treatment along with placebo, and the intervention group received two 500 mg curcumin capsules daily from Sina Pharmaceutical Company containing 370 mg of curcuminoid daily for 12 weeks. In order to investigate possible changes in the participant's important information such as dietary intake, physical activity and tobacco use, participant's information will be collected by questionnaires before and after the intervention. Respiratory capacity and pulmonary function adequacy indices will also be measured and compared through Anemometry (spirometry), serum IL-6 levels and bioelectric resistance analysis before and after the intervention.
Participants/Inclusion and exclusion criteria
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
Intervention groups
The case group will receive two 500 mg curcumin capsules (Sina Pharmaceutical Company) daily for 3 months.
The control group will receive two placebo capsules daily (Sina Company, consisting of polysorbate, propylene glycol and distilled water) for 3 months.
Main outcome variables
FEV1/FEC; Interleukin-6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191222045853N1
Registration date:2020-02-06, 1398/11/17
Registration timing:registered_while_recruiting
Last update:2020-02-06, 1398/11/17
Update count:2
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Mahdieh Zareie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3278 0803
Email address
mahdieh.zareie72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin supplementatin on ventilatory capacity, polmonary function indices and serum interleukin-6 of patients with stage 3 (severe) and 4 (very severe) chronic obstructive pulmonary disease
Public title
The effects of curcumin on obstructive pulmonary disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using coding on supplements
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Intervention group: Curcumin Supplement, two capsules daily, each capsule containing 370 mg of curcurominoid, for 12 weeks, consumed with food, produced by Sina company.
Category
Treatment - Drugs
2
Description
Control group: Placebo, two capsules daily, each capsule containing 100 mg of starch, for 12 weeks, consumed with food, produced by Sina company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Rasoul Zarrin
Street address
Ayatollah Blvd. Modares - Ershad Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3345 9538
Email
wwzarrin@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zarrin
Street address
Ayatollah Blvd. Modares - Ershad Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3345 9538
Email
wwzarrin@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zarrin
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3222 9059
Email
mahdieh.zareie72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mahdieh Zareie
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition department, school of medical sciences, Urmia University of Medical Sciences, Nazlou Rd.
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3278 0803
Fax
Email
mahdieh.zareie72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mahdieh Zareie
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition department, school of medical sciences, Urmia University of Medical Sciences, Nazlou Rd.
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3278 0803
Fax
Email
mahdieh.zareie72@gmail.com
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