Protocol summary

Study aim
Investigating the effect of using the GreenNature Deep Lung Support product on the clinical condition of patients with COPD exacerbation
Design
The present study is a clinical trial with one control group and two intervention groups, with parallel and double-blind groups, randomized with a sample size of 60 patients. After randomly assigning the patients to three groups, the patients of the first group will receive placebo, the patients of the second group will receive one capsule of deep lung support daily, and the patients of the third group will be given three doses of this supplement daily.Then, on the first day and the day of discharge (ten days later), blood samples will be collected from all patients and clinical symptoms and factors including TNF-a, IL-8, CDC, and CRP will be compared in patients of three groups.
Settings and conduct
The present study is conducted as a clinical trial on patients with COPD exacerbation referred to Masih Deneshvari Hospital in Tehran. All patients who meet the inclusion criteria will be placed in one of the three study groups after providing full explanations and obtaining written consent.
Participants/Inclusion and exclusion criteria
Inclusion criteria include COPD exacerbation grade D, BMI>18<21 and smoking. Exclusion criteria include the patient's lack of consent to participate in the study, defects in the file, and drug sensitivity.
Intervention groups
The patients of the control group will receive placebo, the patients of the first intervention group will be given one capsule of deep lung support daily, and the patients of the second intervention group will be given three doses of this supplement daily.
Main outcome variables
Borg scale, MMRC, cough, sputum, PH, PCO2, HCO3, lymphocyte, neutrophil, urea, creatinine, AST, ALT, ALP, IL-6, ferritin, D-dimer, LDH T, procalcitonin, TNF-α, IL- 8, CRP, ESR, WBC, RBC

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200611047727N5
Registration date: 2023-02-21, 1401/12/02
Registration timing: prospective

Last update: 2023-02-21, 1401/12/02
Update count: 0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Maryam Sadat Mirenayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 5050
Email address
mirenayat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using the GreenNature Deep Lung Support product on the clinical condition of patients with COPD exacerbation
Public title
Investigating the effect of using GreenNature Deep Lung Support product in COPD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COPD exacerbation grade D Smoking BMI greater than 18 and less than 21
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual randomization unit and random number table randomization tool. For randomization, we use a table consisting of random digits from 0 to 9. Each of the figures in this table is repeated the same on average. We start from the first row of the table and move down row by row. For three treatments, we put numbers 1 to 3 for treatment A, numbers 4 to 6 for treatment B, and numbers 7 to 9 for treatment C. We continue the above process until three groups are completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to prevent any possible complications, the doctor and clinical caregiver are fully aware of the assignment of treatment groups. Participating patients and researchers responsible for data collection and analysis are not aware of the allocation of different study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SBMUNRITLD.REC.1401.123

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with (acute) exacerbation

Primary outcomes

1

Description
AST
Timepoint
The first day and the next ten days
Method of measurement
Laboratory tests

2

Description
ALT
Timepoint
The first day and the next ten days
Method of measurement
Laboratory tests

3

Description
IL-6
Timepoint
The first day and the next ten days
Method of measurement
Laboratory tests

4

Description
Ferritin
Timepoint
The first day and the next ten days
Method of measurement
Laboratory tests

5

Description
Procalcitonin
Timepoint
The first day and the next ten days
Method of measurement
Laboratory tests

Secondary outcomes

empty

Intervention groups

1

Description
Control group: patients in the control group receive a placebo capsule daily.
Category
Placebo

2

Description
Intervention group: Patients of this group receive one deep lung support capsule made by DayGgen Pharmed company orally and once a day.The chemical composition of this medicine includes the dry extract of Andrographis paniculata, Echinacea purpurea, Eriobotrya japonica, Fritillaria cirrhosa, Olea europaea, Scutellaria baicalensis, and taraxacum officinale.
Category
Treatment - Drugs

3

Description
Intervention group: The patients of this group receive three capsules of deep lung support made by DayaGen Pharmed orally three times a day. The chemical composition of this medicine includes the dry extract of Andrographis paniculata, Echinacea purpurea, Eriobotrya japonica, Fritillaria cirrhosa, Olea europaea, Scutellaria baicalensis, and taraxacum officinale.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Deneshvari Hospital
Full name of responsible person
Maryam Sadat Mirenayat
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
mirenayat@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
195694413
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
DAYAGEN pharmed
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Sadat Mirenayat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
195694413
Phone
+98 21 2712 2020
Email
MirenayaT_M@yahoo.om

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad.
City
Tehran
Province
Tehran
Postal code
195694413
Phone
+98 21 2712 2020
Email
fakharian_2005@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhaneh Zahiri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biotechnology
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
195694413
Phone
+98 21 2712 2020
Email
zahirireyhane@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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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