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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

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History
# Registration date Revision Id
3 2023-10-29, 1402/08/07 283738
2 2021-04-06, 1400/01/17 177587
1 2020-02-06, 1398/11/17 120834
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  • Primary outcomes

    #1
    erythrocyte sedimentation rate
    Interleukin-6
    میزان طبیعی سدیمانتاسیون
    اینترلوکین-6
    #2
    C reactive protein
    spirometry
    پروتئین واکنشگر C
    اسپیرومتری
    blood sample
    Spirometere
    نمونه خونی
    اسپیرومتر
    #3
    Na+
    Bioelectrical impedance analysis
    سدیم
    آنالیز امپدانس بیوالکتریکی
    blood sample
    Bioelectric impedance device
    نمونه خونی
    دستگاه امپدانس بیوالکتریک
    #4
    K+
    Blood pressure
    پتاسیم
    فشار خون
    blood sample
    sphygmomanometer
    نمونه خونی
    اسفیگمومانومتر
    #5
    Ca2+
    empty
    کلسیم
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #6
    creatinine
    empty
    کراتینین
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #7
    Fasting blood glucose
    empty
    قند خون در حالت ناشتا
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #8
    Triglyceride
    empty
    تری گلیسرید
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #9
    Cholesterol
    empty
    کلسترول
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #10
    Low density lipoprotein
    empty
    لیپوپروتئین با چگالی پایین
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #11
    high density lipoprotein
    empty
    لیپوپروتئین با چگالی
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #12
    Albumin
    empty
    آلبومین
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #13
    Capillary blood glucose (CBG)
    empty
    قند خون مویرگی
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #14
    Arterial blood gas (ABG)
    empty
    گاز خون مویرگی
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    blood sample
    empty
    نمونه خونی
    empty
    #15
    spirometry
    empty
    اسپیرومتری
    empty
    beginning and end of supplementation
    empty
    ابتدا و انتهای مکمل یاری
    empty
    Spirometere
    empty
    اسپیرومتر
    empty

  • Intervention groups

    #1
    Intervention group: Curcumin Supplement, two capsules daily, each capsule containing 370 mg of curcurominoid, for 12 weeks, consumed with food, produced by Sina company.
    Intervention group: Curcumin Supplement, one capsule daily, each capsule containing 500 mg of nano-curcumin, for 12 weeks, consumed with food, produced by Sina company.
    گروه مداخله: مکمل کورکومین، روزانه دو کپسول، هر کپسول حاوی 370 میلی گرم کورکورمینویید، به مدت 12 هفته، مصرف همراه با غذا، ساخت کارخانه سینا.
    گروه مداخله: مکمل کورکومین، روزانه یک کپسول، هر کپسول حاوی 500 میلی گرم نانوکورکومین، به مدت 12 هفته، مصرف همراه با غذا، ساخت کارخانه سینا.

  • Recruitment centers

    #1
    Name of recruitment center - English: Emam Khomeini hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: Rasoul Zarrin
    Full name of responsible person - Persian: رسول زرین
    Street address - English: Ayatollah Blvd. Modares - Ershad Boulevard
    Street address - Persian: بلوار آیت ا... مــدرس - بلوار ارشاد
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 81351-57157
    Phone: +98 44 3345 9538
    Fax:
    Email: wwzarrin@hotmail.com
    Web page address:
    Name of recruitment center - English: Emam Khomeini hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: Rasoul Zarrin
    Full name of responsible person - Persian: رسول زرین
    Street address - English: Emam Khomeini Hospital, Ershad Blvd., Ayatollah Modares Blvd
    Street address - Persian: بلوار آیت ا... مــدرس - بلوار ارشاد- بیمارستان امام خمینی
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 81351-57157
    Phone: +98 44 3345 9538
    Fax:
    Email: wwzarrin@hotmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Zarrin
    Full name of responsible person - Persian: رسول زرین
    Street address - English: Ayatollah Blvd. Modares - Ershad Boulevard
    Street address - Persian: بلوار ارشاد، بلوار آیت الله مدرس
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 81351-57157
    Phone: +98 44 3345 9538
    Fax:
    Email: wwzarrin@hotmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Zarrin
    Full name of responsible person - Persian: رسول زرین
    Street address - English: Emam Khomeini hospital., Ershad Blvd., Ayatollah Modares Blvd
    Street address - Persian: بلوار ارشاد، بلوار آیت الله مدرس، بیمارستان امام خمینی
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 81351-57157
    Phone: +98 44 3345 9538
    Fax:
    Email: wwzarrin@hotmail.com
    Web page address:

Protocol summary

Study aim
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: 2021-04-06, 1400/01/17
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
Street address
Orjhans Street, Resalat Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-12-07, 1397/09/16
Ethics committee reference number
IR.UMSU.REC.1398.295

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Interleukin-6
Timepoint
beginning and end of supplementation
Method of measurement
blood sample

2

Description
spirometry
Timepoint
beginning and end of supplementation
Method of measurement
Spirometere

3

Description
Bioelectrical impedance analysis
Timepoint
beginning and end of supplementation
Method of measurement
Bioelectric impedance device

4

Description
Blood pressure
Timepoint
beginning and end of supplementation
Method of measurement
sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Curcumin Supplement, one capsule daily, each capsule containing 500 mg of nano-curcumin, 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
Emam Khomeini Hospital, Ershad Blvd., Ayatollah Modares Blvd
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
Emam Khomeini hospital., Ershad Blvd., Ayatollah Modares Blvd
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
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