Evaluation the effects of Cordia myxa syrup on the symptoms of Chronic bronchitis patients.

Determination and comparison of the effects of *Cordia myxa* syrup on the symptoms of patients with chronic bronchitis in the intervention and control groups.

A Phase 2, randomized, double-blind, parallel-group, controlled clinical trial involving 100 patients. The Excel `rand` function was used for randomization.

The procedure was explained above. It is performed at the specialized pulmonary clinic in the city of Yazd.

Inclusion criteria: 1- Chronic sputum production and a decrease in FEV1 to less than 80% for at least 3 months over two consecutive years 2- 30% < FEV1 < 80% 3- Age 40 to 75 years 4- Diagnosis confirmed by a pulmonologist 5- No symptoms of the common cold or pneumonia within the past month 6- No hospitalization within the past month 7- No use of other expectorants or mucolytics

Eligible patients will be randomly selected and allocated to the drug or placebo group using a double-blind design, with balanced representation by sex and disease severity. All patients will receive standard COPD treatment and take the study medication three times daily, one tablespoon per dose. Clinical symptoms (cough, sputum, dyspnea, sleep quality, and daily functioning) will be assessed before treatment and after one month using the BSS, SGRQ, and CAT scales. Treatment adherence and adverse effects will be monitored by telephone. Drug safety will be evaluated, and data will be analyzed using SPSS version 24.

Cough Phlegm Shortness of breath Nighttime sleep Daily functioning

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.

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.

Information regarding the study results, the drug's efficacy (or lack thereof), instructions for use, and indications.

Once the results are confirmed—likely starting in early 1406...

All physicians, students, and individuals associated with the medical field.

In order to provide better treatment for patients, and under conditions that meet at least the minimum financial requirements for the future...

The manufacturing company and the individuals involved in the development of this drug.

Based on clinical indications and following physician approval, via an online or paper prescription.