A11474 Captophyte as an alternate regimen in controlling stage 1 essential hypertension

Abstract

Objectives: According to NICE guidelines, first line treatment for stage 1 essential hypertension (EH) is either angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB). This clinical trial was designed to check the efficacy of a marine herbal compound vs Captopril in controlling first stage of EH (trial registration no: IRCT2015020110326N2) (patent registry number: IRIPO139350140003012176) Methods: A double blind phase 2 cross-over clinical trial was designed in patients with stage 1 EH. The hypertension was checked according to JNC-7 guidelines, biochemical tests were taken prior to initiation of anti-hypertensive medication. Inclusion criteria were: EH (Phase 1, no response to diet and exercise), no medications metabolized by CYP450. The patients were allocated randomly by random number generator. The patients either received Captopril 25 mg TID of Captophyte 2.050 g TID (compound with ACEI and renin inhibition (RI) mechanisms). After 2 weeks of treatment, patients had a washout period of 10 days with placebo and the medication was changed. During the treatment period patients were weekly monitored for blood pressure control. Data were analysed by descriptive statistics and paired t-test. Results: A total of 3600 patients were screened for EH and only 49 met the inclusion criteria (46 men and 3 women). Range of age was 25–55 yrs. SBP and DBP were 153 ± 4.53 mmHg, and 91.44 ± 2.44 mmHg, and after treatment the SBP and DBP were 130.16 ± 3.9 mmHg and 83 ± 2.41 mmHg respectively. Paired t-test was performed (p < 0.001) Conclusion: This compound which acts through RI and ACEI is equivocal to traditional ACEI in controlling HTN mainly because of chemical compounds which combat oxidative stress,(main culprit in pathogenesis of hypertension) and can be used as an alternate treatment for HTN