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IRCT20251207068231N1 IRCT 2025-12-14 Bagheiat-allah University of Medical Sciences The effect of ajwain (Trachyspermum ammi) extract on blood pressure The effect of Trachyspermum ammi(ajwain) extract on blood pressure of patients at risk for hypertension referring to Afshar cardiac Clinic in Yazd 2025-12-22 anticipated 80 Complete https://irct.ir/trial/87954 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization will be utilized to allocate eligible participants to the intervention (Ajwain extract) and control (placebo) groups. The unit of randomization is individual, with each participant being independently randomized. The randomization tool will be a statistical software package. The random allocation sequence will be generated by a specialized statistician independent of the research team and applied as anonymous codes to the treatment capsules. For allocation concealment, the study will be conducted as a double-blind trial. Both the Ajwain extract and placebo capsules are prepared to be completely identical in appearance and are labeled only with these anonymous codes. The master list, which links the codes to the actual treatment allocation (Ajwain extract or placebo), will remain sealed with the independent statistician until the completion of data collection and final statistical analysis, Blinding description: In this double-blind study, four main groups of individuals are kept blinded to prevent bias: Participants: They are unaware of the actual nature of the substance received (Ajwain extract or placebo) due to receiving identical and coded capsules. Clinical Care Providers: Personnel responsible for patient care and follow-up remain unaware of each patient's treatment group due to allocation based on code and the identical appearance of the medications. Researchers (Principal and Executive): The research team, during the execution phase and data collection, are unaware of the patients' group allocation due to lack of access to the code-breaking list (master list). Outcome Assessors and Data Collectors: Individuals who record the data and evaluate the study outcomes are kept blinded to the treatment group to ensure impartial recording. N/A High Blood Pressure. Intervention 1: Standardized extract of the plant Ajwain (Trachyspermum ammi).Form and Dosage: This group will receive 250 mg oral capsules containing the Ajwain extract.Standardization and Composition: The extract is standardized based on its main active constituent, Thymol. The concentration of Thymol in the extract should be between 20% and 40%.Daily Dosage: 500 mg of the extract per day (two 250 mg capsules).Frequency: One capsule every 12 hours (twice daily).Duration of Consumption: 8 weeks.Method of Consumption: The capsules are consumed orally with water. Intervention 2: Control group: Substance Used: Placebo capsule containing edible starch powder as a neutral filler. This substance has no pharmacological or therapeutic effect. Dosage: Each participant will receive the placebo equivalent to the volume of the intervention group's capsules (250 milligrams).Frequency and Method of Administration: The administration will be oral in the form of capsules, taken twice a day. This regimen is exactly the same as the intervention group. Duration of Consumption: The duration of placebo consumption will be completely identical to the intervention group, lasting for 8 consecutive weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Currently, the research team does not have a specific plan for sharing the individual unidentifiable data (IPD) of participants in this study. This decision is due to focusing on publishing results as aggregate data, resource constraints for the documentation and secure sharing of IPD, and the necessity of carefully reviewing the ethical complexities and informed consent for this type of disclosure. The final decision will be made in the future and after the study concludes, based on the available resources and the policies of the relevant institutions.
public Mohammadhasan Fakhari Zavareh
No. 4, Ostad Karami Alley, Ma'refat Street, Andisheh Town, Mehravran, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915897331 +98 35 3841 2940 mhfz1378@gmail.com Bagheiat-allah University of Medical Sciences scientific Mahdi Bagheri
Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, South Sheikh Bahaei Street, Molla Sadra Street, Vanak Square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 4574 mbagheri.pharm@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Hypertension Antihypertensive Medication Use Informed Consent and Protocol Adherence People between the ages of 20 and 60 20 years 60 years Both Pregnant or lactating women Patients with severe hepatic or renal impairment Individuals with specific cardiovascular diseases, such as severe aortic stenosis, acute heart failure, or unstable cardiovascular diseases (e.g., unstable angina), where the condition may be exacerbated by changes in blood pressure. The presence of acute infectious or inflammatory diseases at the time of study initiation History of any allergic reaction to Ajwain or other plants of the Apiaceae family (such as celery, parsley) History of any intolerable and severe side effects, such as severe drop in blood pressure (hypotension) or allergic reaction to antihypertensive drugs Consumption of alcohol or other drugs that may affect drug metabolism and general health status. A person taking calcium channel blockers (such as Amlodipine, Nifedipine, and Diltiazem) will not be enrolled in the study because the potential interaction of Ajwain with these drugs may cause a synergistic effect and lead to hypotension. I10 Essential (primary) hypertension Treatment - Drugs Placebo Standardized extract of the plant Ajwain (Trachyspermum ammi).Form and Dosage: This group will receive 250 mg oral capsules containing the Ajwain extract.Standardization and Composition: The extract is standardized based on its main active constituent, Thymol. The concentration of Thymol in the extract should be between 20% and 40%.Daily Dosage: 500 mg of the extract per day (two 250 mg capsules).Frequency: One capsule every 12 hours (twice daily).Duration of Consumption: 8 weeks.Method of Consumption: The capsules are consumed orally with water. Control group: Substance Used: Placebo capsule containing edible starch powder as a neutral filler. This substance has no pharmacological or therapeutic effect. Dosage: Each participant will receive the placebo equivalent to the volume of the intervention group's capsules (250 milligrams).Frequency and Method of Administration: The administration will be oral in the form of capsules, taken twice a day. This regimen is exactly the same as the intervention group. Duration of Consumption: The duration of placebo consumption will be completely identical to the intervention group, lasting for 8 consecutive weeks. Systolic blood pressure. Timepoint: At the start of the study, week four, week eight. Method of measurement: Blood Pressure Monitors. Diastolic blood pressure. Timepoint: At the start of the study, week four, week eight. Method of measurement: Blood Pressure Monitors. HDL Cholesterol. Timepoint: At the start of the study, week eight. Method of measurement: Measuring the amount of HDL in patients' blood samples. LDL Cholesterol. Timepoint: At the start of the study, week eight. Method of measurement: Measuring the amount of LDL in patients' blood samples. Triglycerides. Timepoint: At the start of the study, week eight. Method of measurement: Measuring the amount of triglycerides in patients' blood samples. ALT enzyme level. Timepoint: At the start of the study, week eight. Method of measurement: Measuring the amount of ALT enzyme measured in patients' blood samples. AST enzyme level. Timepoint: At the start of the study, week eight. Method of measurement: Measuring the amount of AST enzyme measured in patients' blood samples. FBS Level. Timepoint: At the start of the study, week eight. Method of measurement: Measuring blood sugar after fasting for at least 8 hours. Bagheiat-allah University of Medical Sciences Approved 2025-11-17 Ethics committee of Baqiyatallah university of medical sciences Sheikh Bahai Street, Vanak Square, Mulla Sadra Square, Baqiyatallah University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)