Investigating the therapeutic effect of polyphenols derived from Ficus carica in COPD: a randomized placebo-controlled clinical trial
Design
This is a single-center, Phase III, randomized, placebo-controlled trial with 60 COPD participants (30 herbal drug, 30 placebo). The primary endpoint is a clinically significant change in CAT questionnaire scores (binary outcome), assessed and FEV1 with 1:1 randomization.
Settings and conduct
The drugs and placebo bottles are coded by a person not involved in the trial. the codes will be used for recording the outcomes. After gathering the outcome data the codes and data will be analyzed by PI.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with moderate COPD (FEV1%<70%predicted), Ex smokers and not current smokers.
Exclusion criteria: patient with congestive heart failure (CHF), asthma, and restrictive lung diseases. Patients with any other types of chronic diseases including kidney, liver, and heart.
Intervention groups
Control group (N = 30), GOLD treatment protocol of COPD plus placebo
Intervention group (N = 30), GOLD treatment protocol of COPD plus Ficus carica fruit extraction pills
Main outcome variables
CAT questionary scores, FEV1
General information
Reason for update
Acronym
FICCOPD
IRCT registration information
IRCT registration number:IRCT20200818048444N5
Registration date:2025-09-24, 1404/07/02
Registration timing:registered_while_recruiting
Last update:2025-09-24, 1404/07/02
Update count:0
Registration date
2025-09-24, 1404/07/02
Registrant information
Name
Khalil Ansarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8093
Email address
dr.ansarin@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of polyphenols derived from Ficus carica in COPD: a randomized placebo-controlled
Public title
Investigating the therapeutic effect of fig extract in COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with mild or moderate COPD (FEV1/FVC<70% and FEV1<80%predicted and > 45% predicted)
no significant bronchodilator response as defined by ATS criteria
All patients should be Ex-smokers who have not smoked within the past 4 months
Exclusion criteria:
patient with congestive heart failure (CHF)
asthma
restrictive lung diseases
patients with any other types of chronic diseases including kidney, liver, and heart disease
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The pills and placebo boxes are coded by an investigator not involved in the research, and the boxes are then distributed to participants by another investigator who is unaware of whether they contain the placebo or the intervention. So, the patients receive randomized treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The pills and placebo boxes are coded by an investigator not involved in the research, and the boxes are then distributed to participants by another investigator who is unaware of whether they contain the placebo or the intervention. after gathering the data patients with their corresponding treatment code, the code table will be obtained from the non-involved investigator by the principal investigator to be analyzed by the analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz medical university
Street address
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
before intervention and 2, 4 , 6 weeks after intervention
Method of measurement
questionnaire- statistical analysis, HPLC and Enzyme assay
Secondary outcomes
1
Description
Oxidative stress biomarkers in EBC
Timepoint
4 weeks
Method of measurement
special kits
Intervention groups
1
Description
Control group:
Category
Placebo
2
Description
Intervention group: The active pharmaceutical ingredients were prepared by the pharmacy colleagues involved in this project at the College of Pharmacy as follows:Pure, dried fig fruit (Ficus carica) was purchased from the market. It was ground using a laboratory herbal grinder, model XJT-DFG500g (Guangzhou Xinjiate Machinery Equipment Co., Ltd., Guangdong, China), to produce a fine powder. One hundred grams of the fruit powder were steeped in one liter of a hydroalcoholic solvent (70% ethanol in distilled water). This process involved repeated maceration under vigorous shaking at room temperature for 24 hours. The entire mixture was then filtered through Whatman filter paper, and the filtrate containing the extract was concentrated using a rotary evaporator (Laborota 4002, Heidolph, Germany) to separate the solvent. The total extract was dried using an air dryer.The extract prepared by this method was then formulated into soft gels by Zahravi Pharmaceutical Company. Each gelatin capsule contained 675 mg of the extract. For the participants, a daily dosage of two capsules, three times a day (totaling 4 grams of fig extract per day), will be administered with meals for a period of three months.The size and color of the placebo capsules were designed to be similar to the drug-containing capsules; however, they were filled with a filler material (microcrystalline cellulose).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Amiri Sadeghan
Full name of responsible person
Khalil Ansarin
Street address
Tanhayie, St, Pashmineh, Tuberculosis and lung disease research center
City
Tabriz
Province
East Azarbaijan
Postal code
51656658112
Phone
+98 41 3337 8093
Email
dr.ansarin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr. Khalil Ansarin
Street address
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
City
Tabriz
Province
East Azarbaijan
Postal code
51656658112
Phone
+98 41 3337 8093
Email
Dr.Ansarin@gmail.com
Grant name
Grant code / Reference number
4021176
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran National Science Foundation
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
2
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khalil Ansarin
Street address
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
City
Tabriz
Province
East Azarbaijan
Postal code
51656658112
Phone
+98 41 3337 8093
Email
Amirisadeghan@Tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran National Science Foundation
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
Tabriz University of Medical Sciences
Full name of responsible person
Amir Amiri Sadeghan
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
City
Tabriz
Province
East Azarbaijan
Postal code
51656658112
Phone
+98 41 3337 8093
Email
Amirisadeghan@Tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir Amiri Sadeghan
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
City
Tabriz
Province
East Azarbaijan
Postal code
51656658112
Phone
+98 41 3337 8093
Email
Amirisadeghan@Tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir Amiri Sadeghan
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
City
Tabriz
Province
East Azarbaijan
Postal code
51656658112
Phone
+98 41 3337 8093
Email
Amirisadeghan@Tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
after acceptance for publication in an appropriate journal
To whom data/document is available
we will participate in open-data journals who provides a link for raw data
Under which criteria data/document could be used
we will obey the the journal ethics on sharing data with third party
From where data/document is obtainable
from the link journal will provide
What processes are involved for a request to access data/document