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IRCT20260815070648N1 IRCT 2026-10-11 Yazd University of Medical Sciences "Cordia myxa syrup in chronic bronchitis" Evaluation the effects of Cordia myxa syrup on the symptoms of Chronic bronchitis patients. 2026-04-21 anticipated 40 Complete https://irct.ir/trial/92878 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, a syrup containing the Cordia myxa herbal preparation was manufactured by a knowledge-based company. The herbal syrup and placebo were then prepared with identical formulation characteristics, volume, appearance, and packaging and were coded as A and B by the manufacturer. The code key was retained by the manufacturer, and the physician, participants, and outcome assessor were unaware of which code corresponded to the active treatment or placebo. After screening for the eligibility criteria and obtaining informed consent, eligible participants were randomly allocated to the two study groups in a 1:1 ratio. A computer-generated random allocation sequence was prepared before the initiation of participant recruitment. For each eligible participant, one of the two treatment codes (A or B) was assigned according to the predetermined random sequence. Thus, allocation was not based on the participant's clinical characteristics, age, sex, order of recruitment, or physician judgment, and each eligible participant had an equal probability of being assigned to either the Cordia myxa or placebo group. Following random allocation, the medication package corresponding to the assigned code was provided to the participant without revealing whether it contained the active Cordia myxa syrup or placebo. Because the two preparations were indistinguishable in appearance and packaging, neither the participants nor the treating physician could predict or identify the treatment assignment. Clinical symptoms and study outcomes were assessed without knowledge of treatment allocation. The code key remained confidential throughout participant recruitment, treatment, and outcome assessment and was unblinded only after completion of data collection and evaluation, Blinding description: First, a syrup based on the *Cordia myxa* plant is prepared by a knowledge-based company; it is then packaged alongside a placebo in identical containers and coded as "A" and "B." The medication and placebo packages are indistinguishable, bearing only the manufacturer's "A" and "B" codes, ensuring that neither the physician nor the patient knows which contains the active drug and which the placebo. Subsequently, patients meeting the specified criteria are selected at random, and the treatments are administered randomly without the patient or physician knowing whether the substance is the drug or the placebo. 3 Chronic Obstructive Pulmonary Disease. Intervention group: First, a syrup based on the *Cordia myxa* plant is prepared by a knowledge-based company; the syrup and a placebo are then packaged identically and coded as "A" and "B." The packages containing the medication and the placebo are indistinguishable, bearing only the "A" and "B" codes assigned by the manufacturer, ensuring that neither the physician nor the patient knows which is the active drug and which is the placebo. Subsequently, patients meeting the specified criteria are selected at random and assigned the treatment—either the medication or the placebo—in a randomized manner, without the patient or physician being aware of the assignment. All patients also receive standard, primary COPD treatment as prescribed by a pulmonologist. The patient is required to take the medication three times daily, with a dosage of one tablespoon each time. Prior to prescribing the medication, the patient's symptoms (including cough, sputum production, and shortness of breath) and their status—assessed using BSS, SGRQ, and CAT criteria—are evaluated and recorded. A follow-up assessment of symptoms is conducted one month later during the subsequent visit. Additionally, adherence to the medication regimen and any potential side effects are monitored via telephone follow-ups.. Yes - There is a plan to make this available What will be shared: Information regarding the study results, the drug's efficacy (or lack thereof), instructions for use, and indications. When: Once the results are confirmed—likely starting in early 1406... To whom: All physicians, students, and individuals associated with the medical field. Conditions: In order to provide better treatment for patients, and under conditions that meet at least the minimum financial requirements for the future... Where to obtain: The manufacturing company and the individuals involved in the development of this drug. How to obtain: Based on clinical indications and following physician approval, via an online or paper prescription. Comments:
public Dr. Fatemeh-Sadat Aghaei
Riazi Square, Ibn Sina Street, Shahid Sadoughi Hospital
Yazd Iran (Islamic Republic of) 8915887857 0353224200 Journal.ssu@gmail.com Yazd University of Medical Sciences scientific Erfan Nasr azadani
Shahid Sadoughi Hospital, Ibn Sina Street
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3822 4200 erfannasrazadani@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Chronic sputum production and a reduction in FEV1 to less than 80% for at least 3 months over two consecutive years. Age 40 to 75 years FEV1 below 80% and above 30% The individual's condition must be confirmed by a pulmonologist. Must not have had symptoms of a cold or pneumonia over the past month. Must not have been hospitalized within the past month. Avoid using other expectorants and mucolytics. 40 years no limit Both FEV1 more than 80% or other chronic lung diseases such as bronchiectasis, tuberculosis, silicosis, etc. Has had symptoms of a cold or pneumonia over the past month. Has been hospitalized within the past month Heart disease J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Intervention group: First, a syrup based on the *Cordia myxa* plant is prepared by a knowledge-based company; the syrup and a placebo are then packaged identically and coded as "A" and "B." The packages containing the medication and the placebo are indistinguishable, bearing only the "A" and "B" codes assigned by the manufacturer, ensuring that neither the physician nor the patient knows which is the active drug and which is the placebo. Subsequently, patients meeting the specified criteria are selected at random and assigned the treatment—either the medication or the placebo—in a randomized manner, without the patient or physician being aware of the assignment. All patients also receive standard, primary COPD treatment as prescribed by a pulmonologist. The patient is required to take the medication three times daily, with a dosage of one tablespoon each time. Prior to prescribing the medication, the patient's symptoms (including cough, sputum production, and shortness of breath) and their status—assessed using BSS, SGRQ, and CAT criteria—are evaluated and recorded. A follow-up assessment of symptoms is conducted one month later during the subsequent visit. Additionally, adherence to the medication regimen and any potential side effects are monitored via telephone follow-ups. Age, Sex, Weight, BMI, Smoking, Substance Dependence, FEV1. Timepoint: One month after taking the medication. Method of measurement: BSS, SGRQ, and CAT criteria. Yazd University of Medical Sciences Approved 2025-12-15 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Bahonar Square, beginning of South Shahid Sadoughi [Street] Yazd Yazd Iran (Islamic Republic of)