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IRCT20171007036614N4 IRCT 2023-10-17 Bagheiat-allah University of Medical Sciences Effectiveness of saffron and herbal formula on respiratory symptoms Effectiveness of saffron and herbal formula (based on chamomile) on respiratory symptoms and inflammatory biomarkers of pulmonary chemical veterans in comparison to placebo 2023-11-22 anticipated 160 Complete https://irct.ir/trial/73196 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are divided into 2 strata. First, patients with underlying disease (diabetes and hypertension) and second, patients without underlying disease. Then patients in each strata randomly divided into 2 groups by the block randomization method perfomed by SPSS software. Strata 1: group 1 receives herbal syrup and group 2 placebo syrup. Strata 2: group 1 saffron capsule and group 2: placebo capsule, Blinding description: Herbal syrup, saffron capsule, and their placebo will be provided in A or B label by a pharmacist who is not involved in performance of the study. Participants of each strata are not aware that they are in which group (intervention or placebo). Outcomes will be measured by a third party who is not aware about group of participants and type of intervention. 2-3 Unspecified injury of lung. Intervention 1: Intervention group, strata 1: Herbal product formulation (containing chamomile, thyme, licorice, jujube, fig, nettle, mistletoe and hyssop) based on the basic study of Karimi et al. (Efficacy of Persian medicine herbal formulations (capsules and decoction) compared to standard care in patients with COVID) -19, a multicenter open-labeled, randomized, controlled clinical trial) with the difference that in this study, the boiled medicine is given to the patients in the form of syrup and a quarter of the dose used in the previous study. Participants without underlying disease will use 10 cc of syrup every 12 hours. The study period will be 8 weeks. Syrup will be standardized based on total phenol. Intervention 2: Intervention group, strata 2: Participants with underlying disease will take one saffron capsule daily (standardized to 15 mg of crocin per capsule) every 12 hours. The study period will be 8 weeks. Intervention 3: Control group, strata 1: The syrup placebo will be prepared by water, sugar and food coloring completely similar to herbal syrup, and the participants will use 10 cc of syrup every 12 hours for 8 weeks. Intervention 4: Control group, strata 2: The placebo capsule will be filled with pectin and will look exactly the same as the intervention capsule, and the patients will use 1 capsule every 12 hours for 8 weeks. Yes - There is a plan to make this available What will be shared: Gathered data will be analyzed and then published. When: After publishing study To whom: Everyone (depending on the journal policies) Conditions: Published article will be public. Where to obtain: The journal that the paper is published in. How to obtain: Sending Email to corresponding author. Comments:
public Mohammad Sadegh Adel Mehraban
Molasadra St.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 4535 sadeghadel@gmail.com Bagheiat-allah University of Medical Sciences scientific Mohammad Sadegh Adel Mehraban
Taleqani St., Ahmadie Clinic
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 4535 sadeghadel@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Confirmation of mustard gas induced lung injury by a pulmonologist Previous asthma Seasonal Allergy Acute respiratory infection Smoking Alcohol consuming 40 years 65 years Male Uncontrolled hypertension Unwilling to participate S27.30 Unspecified injury of lung Treatment - Drugs Treatment - Drugs Placebo Placebo Intervention group, strata 1: Herbal product formulation (containing chamomile, thyme, licorice, jujube, fig, nettle, mistletoe and hyssop) based on the basic study of Karimi et al. (Efficacy of Persian medicine herbal formulations (capsules and decoction) compared to standard care in patients with COVID) -19, a multicenter open-labeled, randomized, controlled clinical trial) with the difference that in this study, the boiled medicine is given to the patients in the form of syrup and a quarter of the dose used in the previous study. Participants without underlying disease will use 10 cc of syrup every 12 hours. The study period will be 8 weeks. Syrup will be standardized based on total phenol. Intervention group, strata 2: Participants with underlying disease will take one saffron capsule daily (standardized to 15 mg of crocin per capsule) every 12 hours. The study period will be 8 weeks. Control group, strata 1: The syrup placebo will be prepared by water, sugar and food coloring completely similar to herbal syrup, and the participants will use 10 cc of syrup every 12 hours for 8 weeks. Control group, strata 2: The placebo capsule will be filled with pectin and will look exactly the same as the intervention capsule, and the patients will use 1 capsule every 12 hours for 8 weeks. Dyspnea severity. Timepoint: Before treatment and after 4 and 8 weeks. Method of measurement: St George's Respiratory Questionnaire. Cough severity. Timepoint: Before treatment and after 4 and 8 weeks. Method of measurement: St George's Respiratory Questionnaire. Interleukin 6. Timepoint: Before treatment and 8 weeks. Method of measurement: ELISA. Glutathione (GSH). Timepoint: Before treatment and 8 weeks. Method of measurement: ELISA. Malondialdehyde (MDA). Timepoint: Before treatment and 8 weeks. Method of measurement: ELISA. Bagheiat-allah University of Medical Sciences Approved 2023-10-02 Research Ethics Committees of Baqiyatallah Hospital Sheikh bahai St., Molasadra Ave. Tehran Tehran Iran (Islamic Republic of)