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IRCT20200818048444N5 IRCT 2025-09-24 Iran National Science Foundation Investigating the therapeutic effect of fig extract in COPD FICCOPD Investigating the therapeutic effect of polyphenols derived from Ficus carica in COPD: a randomized placebo-controlled 2025-08-23 anticipated 30 Recruiting https://irct.ir/trial/82931 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Chronic Obstructive Pulmonary Disease. Intervention 1: Control group:. Intervention 2: 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). Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: after acceptance for publication in an appropriate journal To whom: we will participate in open-data journals who provides a link for raw data Conditions: we will obey the the journal ethics on sharing data with third party Where to obtain: from the link journal will provide How to obtain: not a specific process Comments:
public Amir Amiri Sadeghan
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
Tabriz Iran (Islamic Republic of) 51656658112 +98 41 3337 8093 Amirisadeghan@Tbzmed.ac.ir Tabriz University of Medical Sciences scientific Amir Amiri Sadeghan
Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center
Tabriz Iran (Islamic Republic of) 51656658112 +98 41 3337 8093 Amirisadeghan@Tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Male patient with congestive heart failure (CHF) asthma restrictive lung diseases patients with any other types of chronic diseases including kidney, liver, and heart disease J44.9 Chronic obstructive pulmonary disease, unspecified Placebo Treatment - Drugs Control group: 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). Reduction in CAT score. Timepoint: before intervention and 2, 4 , 6 weeks after intervention. Method of measurement: questionnaire- statistical analysis, HPLC and Enzyme assay. Oxidative stress biomarkers in EBC. Timepoint: 4 weeks. Method of measurement: special kits. Tabriz University of Medical Sciences Iran National Science Foundation Iran National Science Foundation Approved 2025-03-10 Ethics committee of Tabriz medical university Tanhayii, St, Pashmineh, Tuberculosis and lung disease research center Tabriz East Azarbaijan Iran (Islamic Republic of)