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IRCT20170704034900N4 IRCT 2026-10-22 Semnan University of Medical Sciences Studying the effect of the the Squill-Oxymel on patients with occupational obstructive pulmonary disease Studying the effect of the the Squill-Oxymel on patients with occupational obstructive pulmonary disease: A Pilot Randomized Triple-Blinded Placebo-Controlled Clinical Trial 2026-11-21 anticipated 144 Pending https://irct.ir/trial/94177 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, individual-level block randomization will be used to allocate eligible participants to the study groups. After assessment of the inclusion and exclusion criteria and obtaining written informed consent, participants will be randomly assigned in a 1:1:1:1 allocation ratio to four groups: Group A (Squill-Oxymel plus standard treatment), Group B (placebo plus standard treatment), Group C (Squill-Oxymel without standard treatment), and Group D (placebo without standard treatment). It is proposed that the random allocation sequence be generated using statistical software with randomly varying block sizes of 4 and 8 by an independent researcher who is not involved in participant recruitment, clinical assessment, or outcome evaluation. Within each block, participants will be randomly allocated to the four study groups to maintain balanced group sizes while minimizing the predictability of subsequent assignments. No stratification is proposed. To ensure allocation concealment, it is proposed that the randomization sequence be maintained by an independent researcher using sequentially numbered, opaque, sealed envelopes. Each envelope will be opened only after confirmation of eligibility, completion of baseline assessments, and formal enrollment of the participant. Allocation codes will remain confidential until completion of the study and data analysis, except when emergency unblinding is necessary to ensure participant safety, Blinding description: In this study, blinding will be implemented to minimize potential bias during intervention administration and outcome assessment. Three categories, including participants, the investigator, and outcome assessors, will be blinded to the allocation of Squill-Oxymel or placebo. Squill-Oxymel syrup and placebo will be prepared to be as similar as possible in color, taste, odor, consistency, volume, and packaging. The study products will be labeled with unique identification codes without indicating whether they contain the active intervention or placebo. Product coding will be performed by an independent individual who is not involved in the research procedures. The confidential code list will be securely maintained until completion of the study. Participants will be informed about their participation in the clinical trial and the possibility of receiving either Squill-Oxymel or placebo, but they will remain unaware of the assigned product. The investigator responsible for conducting the study and the outcome assessors will not have access to the treatment allocation codes. Pulmonary function outcomes, including FEV1, FVC, FEV1/FVC, FEF25–75, and PIF, will be assessed at baseline, day 30, and day 60 without the outcome assessors being informed of the assigned study product. Clinical care providers responsible for prescribing or supervising standard treatment may not be blinded to the standard-treatment component of group allocation if they are aware of whether participants receive standard treatment. Adverse events and clinical conditions will be monitored and documented throughout the study. Emergency unblinding will be permitted when knowledge of the assigned study product is essential for appropriate clinical management of a serious adverse event. 3 Condition 1: occupational asthma. Condition 2: Occupational Chronic Obstructive Pulmonary Disease (Occupational COPD). Intervention 1: Intervention group: Intervention group 1: Participants in this group will receive Squill Oxymel syrup manufactured by Niak Pharmaceutical Company, a traditional herbal formulation containing squill (Drimia maritima), honey, and vinegar, supplied in 200 mL bottles. The syrup will be administered orally at a dose of 10 mL twice daily for 60 days. Participants will continue to receive standard treatment for occupational obstructive lung disease as prescribed by their treating physician. Intervention 2: Intervention group: Intervention group 2: Participants in this group will receive Squill Oxymel syrup manufactured by Niak Pharmaceutical Company, a traditional herbal formulation containing squill (Drimia maritima), honey, and vinegar, supplied in 200 mL bottles. The syrup will be administered orally at a dose of 10 mL twice daily for 60 days. According to the initial study protocol, participants in this group will not receive standard treatment for occupational obstructive lung disease. Intervention 3: Control group: Control group: Participants in this group will receive 10 mL of oral placebo syrup twice daily for 60 days. The placebo will be prepared to match the Squill Oxymel syrup manufactured by Niak Pharmaceutical Company in color, taste, odor, consistency, volume, and packaging, but will not contain the active constituents of the squill plant. Participants will continue to receive standard treatment for occupational obstructive lung disease as prescribed by their treating physician. Intervention 4: Control group: Intervention group 3: Participants in this group will receive 10 mL of oral placebo syrup twice daily for 60 days. The placebo will be prepared to match the active Squill Oxymel formulation in appearance and packaging, without containing the active constituents of the squill plant. According to the initial study protocol, participants in this group will not receive standard treatment for occupational obstructive lung disease. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data collected during the clinical trial, including demographic characteristics, pulmonary function measurements, respiratory symptoms, treatment allocation, and adverse events, as well as the study protocol and data collection forms. All personal identifiers will be removed before sharing. When: Data and supporting documents will be available beginning six months after publication of the main study results and will remain accessible for five years thereafter, subject to applicable ethical and institutional requirements. To whom: Qualified researchers affiliated with universities, academic institutions, research centers, or healthcare organizations may request access to the data and supporting documents for legitimate scientific purposes. Conditions: Data may be used for scientific research, secondary analyses, systematic reviews, and meta analyses. Applicants must submit a research proposal describing the intended use of the data. Access will be subject to approval by the principal investigator and applicable ethics requirements. Attempts to identify participants, unauthorized redistribution, and commercial use without permission are prohibited. Where to obtain: Data access requests should be submitted by email to the research team at Semnan University of Medical Sciences, Semnan, Iran. Contact person: Sobhan Sangesari Email: sobhansangesari@gmail.com Requests will be forwarded to the principal investigator for review and approval. How to obtain: Applicants must submit a written request specifying their institutional affiliation, research objectives, and intended analyses. The research team will review the request and assess ethical compliance. A decision will normally be communicated within 30 days of receiving a complete application. Following approval and completion of any required data sharing agreement, the requested documents or deidentified data will be provided through a secure electronic method within 15 working days. Comments:
public sobhan sangesari
Imam Town, next to Maskan-e Melli
sorkheh Iran (Islamic Republic of) 3551763457 +98 23 3361 5232 sobhansangesari@gmail.com Semnan University of Medical Sciences scientific Daryosh Pahlevan
Headquarters, Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan, Iran
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 dpahlevan@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Employment in an occupational environment with documented exposure to respiratory hazards for at least one year Documented occupational exposure to respiratory hazards such as industrial dust, fumes, chemical vapors, or gases Presence of chronic respiratory symptoms consistent with obstructive lung disease, including dyspnea, chronic cough, wheezing, or chest tightness Spirometric findings consistent with obstructive lung disease, including reduced FEV1 and an FEV1/FVC ratio below 0.70 Ability to perform acceptable and reproducible spirometry according to ATS/ERS standards 18 years 65 years Both Presence of non-obstructive pulmonary diseases History of severe cardiovascular diseases History of heavy smoking exceeding 20 pack-years Active respiratory infection or history of respiratory infection within the past four weeks Pregnancy or breastfeeding Unwillingness to participate in the study J45.9 J44.9 Other and unspecified asthma Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Treatment - Drugs Placebo Placebo Intervention group: Intervention group 1: Participants in this group will receive Squill Oxymel syrup manufactured by Niak Pharmaceutical Company, a traditional herbal formulation containing squill (Drimia maritima), honey, and vinegar, supplied in 200 mL bottles. The syrup will be administered orally at a dose of 10 mL twice daily for 60 days. Participants will continue to receive standard treatment for occupational obstructive lung disease as prescribed by their treating physician. Intervention group: Intervention group 2: Participants in this group will receive Squill Oxymel syrup manufactured by Niak Pharmaceutical Company, a traditional herbal formulation containing squill (Drimia maritima), honey, and vinegar, supplied in 200 mL bottles. The syrup will be administered orally at a dose of 10 mL twice daily for 60 days. According to the initial study protocol, participants in this group will not receive standard treatment for occupational obstructive lung disease. Control group: Control group: Participants in this group will receive 10 mL of oral placebo syrup twice daily for 60 days. The placebo will be prepared to match the Squill Oxymel syrup manufactured by Niak Pharmaceutical Company in color, taste, odor, consistency, volume, and packaging, but will not contain the active constituents of the squill plant. Participants will continue to receive standard treatment for occupational obstructive lung disease as prescribed by their treating physician. Control group: Intervention group 3: Participants in this group will receive 10 mL of oral placebo syrup twice daily for 60 days. The placebo will be prepared to match the active Squill Oxymel formulation in appearance and packaging, without containing the active constituents of the squill plant. According to the initial study protocol, participants in this group will not receive standard treatment for occupational obstructive lung disease. Change in forced expiratory volume in one second from baseline following the intervention. Timepoint: At baseline before the intervention and on days 30 and 60 after initiation of the intervention. Method of measurement: Measurement using a calibrated spirometer according to the American Thoracic Society and European Respiratory Society standards, expressed in liters. Change in forced vital capacity from baseline following the intervention. Timepoint: At baseline before the intervention and on days 30 and 60 after initiation of the intervention. Method of measurement: Measurement using a calibrated spirometer according to the American Thoracic Society and European Respiratory Society standards, expressed in liters. Niak pharmaceutical company Semnan University of Medical Sciences Niak pharmaceutical company Approved 2026-07-27 Ethics committee of Semnan University of Medical Sciences Deputy of Research and Technology, Central Headquarters, Semnan University of Medical Sciences, Basij Boulevard, Semnan, Iran semnan Semnan Iran (Islamic Republic of)