Evaluation the effect of Althaea officinalis extract oral solution on blood pressure levels in patients with high blood pressure (HTN): A randomized double blind clinical trial

To determine the effect of the oral solution of hibiscus extract on systolic blood pressure in individuals with hypertension after 2 weeks of consumption and to compare it with a placebo.

A controlled clinical trial with parallel groups, double-blind, randomized, Phase 2 study on 70 patients. Consultation with statistical experts was sought for randomization

The study is a double-blind clinical trial. Both the therapist and the patient are unaware of the medication given. Patients with hypertension who are being treated with oral antihypertensive medications and have poor control will be selected for outpatient visits to the Iranian Traditional Medicine Health Center of Jundi Shapur in Ahvaz. In the treatment group, in addition to antihypertensive medications, an oral solution of marshmallow extract prepared by Zarband Pharmaceutical Company will be administered twice daily at a dosage of 10 milliliters for two weeks. In the placebo group, in addition to their previous medications, a placebo will be given twice daily at twelve-hour intervals for two weeks.

Inclusion Criteria Age between 25 and 70 years Blood pressure of 90/140 mmHg or higher Patients should only be using oral antihypertensive medications. Exclusion Criteria Pregnancy Breastfeeding Significant renal failure Liver failure

The treatment group will receive, in addition to antihypertensive medications, an oral solution of marshmallow extract prepared by Zarband Pharmaceutical Company, administered twice daily at a dosage of 10 milliliters for two weeks. The placebo group will receive a placebo in addition to their previous medications, also administered twice daily at twelve-hour intervals. These medications will be given to the patients for a duration of two weeks.

Control and Reduction of Blood Pressure

The permutation block randomization method is used. Blocking is usually used to balance the number of samples allocated to each of the study groups. This feature helps researchers to ensure that the number of samples allocated to each of the study groups is equal in cases where interim analyses are needed during the sampling process. In this two-group clinical trial, the block size is 4. The allocation ratio between the two groups is 1:1. The randomization tool is the blockrand package of R software. For concealment, we use random allocation concealment. This method is used to perform random sequence on participants in such a way that the assigned group is not known before the individual is assigned. Using sealed opaque envelopes with a random sequence, in which each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the envelopes are sealed and placed in a box in order. When participant registration begins, based on the order of entry into the study, one of the envelopes is opened in order and the assigned group of that participant is revealed.

To control the entry criteria for the study, the initial visit will be conducted by a physician. Coded medications will be prepared and delivered to the study assistant, who will not be informed about the types of medications. The codes will be sent separately in sealed envelopes so that neither the researcher nor the patient will be aware of the contents of the medication container until the end of the study. The medications will be administered to the patients by the study assistant using a random block method. Patients will be divided into two groups (35 individuals in each group) using a randomization list prepared by a statistical consultant.