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IRCT20130207012391N3 IRCT 2026-08-10 Iran University of Medical Sciences Investigating the Effect of Asrol Capsule on Hypertension Evaluating Asrol Capsule as an Add-on to Standard Treatment for Primary Hypertension: A Randomized, Double-blind, Placebo-controlled Trial 2026-09-11 anticipated 92 Recruiting https://irct.ir/trial/92073 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling will be used to recruit eligible participants with primary hypertension. After screening based on the predefined inclusion and exclusion criteria, a unique identification number will be assigned to each eligible individual, and the required number of participants will be selected using a random numbers table. Conventional randomization methods are not effective in randomized clinical trials of Persian medicine because they do not take individuals’ temperament characteristics into account. During the randomization process, the treatment groups may differ significantly in some prognostic and temperament-related factors, particularly when the sample size is relatively small (less than 200). If these factors have important effects on the study’s primary or secondary outcomes, any significant differences in the levels of these factors will affect the trial results. Various methods are used to overcome the problem of unmatched experimental groups, including minimization and stratification, with minimization providing more acceptable, Blinding description: This study will be conducted as a double-blind trial. To maintain blinding, the Asrol capsules and their placebo will be identical in terms of shape, size, color, packaging, and labeling. In addition, the placebo for the standard antihypertensive medication will be similar to the active product in appearance and administration schedule. Accordingly, all participants in both groups will receive the standard medication and the study capsules in similar packaging, and participants, investigators, and outcome assessors will remain unaware of group allocation. The allocation code will be kept by the statistician until the end of the study, and the participants, investigators, and outcome assessors will remain unaware of group allocation. 2 Hypertension. Intervention 1: Control group: Patients in this group receive standard antihypertensive medications along with a 500 mg placebo capsule (containing wheat starch). The placebo capsules are identical to the Asrol capsules in appearance, size, color, taste, and packaging. The medication is administered orally, twice a day (one capsule after breakfast and one after dinner), for a duration of 6 weeks. Intervention 2: Intervention group: Patients in this group receive standard antihypertensive medications along with a 500 mg herbal “Asrol” capsule (manufactured by Talaye Sabze Tooba Company). The capsule contains a mixture of 13 medicinal herbs: Borage, Lemon balm, Orange blossom, Lavender, Chamomile, Rose, Lemon verbena, and Coriander seed (30.1 mg each); Valerian, Cranberry, and Sour tea (60.2 mg each); Nigella sativa and Asrol root (39.13 mg each). The medication is administered orally, twice a day (one capsule after breakfast and one after dinner), for a duration of 6 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 There is no more information.
public Roshanak Ghods
No. 847 (3rd Floor), Persian Medciine School, Behesht intersection., Vahdat-e Eslami St., Tehran
Tehran Iran (Islamic Republic of) 1611738913 +98 21 5558 0388 ghods.r@iums.ac.ir Iran University of Medical Sciences scientific Roshanak Ghods
No. 847 (3rd Floor), Persian Medciine School, Behesht intersection., Vahdat-e Eslami St., Tehran
Tehran Iran (Islamic Republic of) 1611738913 +98 21 5558 0388 ghods.r@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 80 years Diagnosis of primary hypertension, stage I or II, based on the AHA 2025 guideline Patients determined by a cardiologist to be candidates for initiation of pharmacologic treatment 18 years 80 years Both Baseline blood pressure greater than 180/110 mmHg Patients with angina syndromes, unstable angina, myocardial infarction, heart failure, stroke, or other cardiovascular diseases History of any allergy to medicinal plants, including borage, lemon balm, lavender, chamomile, rose, orange blossom, lemon verbena, coriander seed, valerian, bilberry, hibiscus, black seed, or acerola root Use of hypnotic or sedative medications Patients with depression or those currently taking antidepressant medicationsUse of digitalis glycosides Use of neuroleptic drugs, barbiturates, or levodopa Use of sympathomimetic drugs, including cough and cold medications or appetite suppressants Use of anticoagulant or antiplatelet medications Use of digitalis glycosides Alcohol consumption Hypothyroidism Liver disorders or renal failure Pregnancy or breastfeeding History of gastrointestinal ulcers Bradycardia Patients complaining of impotence or decreased libido Gynecomasti Patients with a history of nasal polyps, severe nasal congestion, or recurrent epistaxis 110 Essential (primary) hypertension Placebo Treatment - Drugs Control group: Patients in this group receive standard antihypertensive medications along with a 500 mg placebo capsule (containing wheat starch). The placebo capsules are identical to the Asrol capsules in appearance, size, color, taste, and packaging. The medication is administered orally, twice a day (one capsule after breakfast and one after dinner), for a duration of 6 weeks. Intervention group: Patients in this group receive standard antihypertensive medications along with a 500 mg herbal “Asrol” capsule (manufactured by Talaye Sabze Tooba Company). The capsule contains a mixture of 13 medicinal herbs: Borage, Lemon balm, Orange blossom, Lavender, Chamomile, Rose, Lemon verbena, and Coriander seed (30.1 mg each); Valerian, Cranberry, and Sour tea (60.2 mg each); Nigella sativa and Asrol root (39.13 mg each). The medication is administered orally, twice a day (one capsule after breakfast and one after dinner), for a duration of 6 weeks. Mean systolic blood pressure of the patient, measured in millimeters of mercury (mmHg) after at least 5 minutes of rest. Timepoint: At baseline and at weeks 2, 4, and 6 after the start of the intervention. Method of measurement: Standard digital upper-arm sphygmomanometer (Omron brand). Mean diastolic blood pressure of the patient, measured in millimeters of mercury (mmHg) after at least 5 minutes of rest. Timepoint: At baseline and at weeks 2, 4, and 6 after the start of the intervention. Method of measurement: Standard digital upper-arm sphygmomanometer (Omron brand). Mean pulse pressure of the patient (calculated as the difference between systolic and diastolic blood pressure). Timepoint: At baseline, and at weeks 2, 4, and 6 after the start of the intervention. Method of measurement: Calculated formula (Pulse Pressure=SBP−DBP) based on measurements from a standard digital sphygmomanometer. Blood and Urine Sodium (Na) level. Timepoint: At baseline and at the end of week 6. Method of measurement: Standard laboratory blood and urine test. Blood Potassium (K) level. Timepoint: At baseline and at the end of week 6. Method of measurement: Standard laboratory blood test. Blood Urea Nitrogen (BUN) level. Timepoint: At baseline and at the end of week 6. Method of measurement: Standard laboratory blood test. Blood Creatinine (Cr) level. Timepoint: At baseline and at the end of week 6. Method of measurement: Standard laboratory blood test. Liver enzyme SGOT (Serum Glutamic-Oxaloacetic Transaminase or AST) level. Timepoint: At baseline and at the end of week 6. Method of measurement: Standard laboratory blood test. Liver enzyme SGPT ( Serum Glutamic-Pyruvic Transaminase or ALT) level. Timepoint: At baseline and at the end of week 6. Method of measurement: Standard laboratory blood test. Iran University of Medical Sciences Approved 2026-07-13 Ethics committee of Iran University of Medical Sciences Secretariat of the Ethics Committee, Vice-Chancellor for Research and Technology, 5th Floor, Central Headquarters, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)