Tengfu Jiangya Tablet for Grade 1 Hypertension Patients with Gan-Yang Hyperactivity Syndrome:A Randomized Controlled Trial
Objective To evaluate the efficacy and safety of Tengfu Jiangya Tablet(TJT)in the treatment of patients with grade 1 hypertension and Gan-Yang hyperactivity syndrome.Methods A total of 130 patients with grade 1 hypertension and Gan-Yang hyperactivity syndrome were included using a randomized,single-blind,placebo-controlled parallel design,with 65 patients in the control group and 65 patients in the experimental group.The experimental group received lifestyle guidance plus TJT twice daily(1.5 g per dose),while the control group received lifestyle guidance plus placebo TJT twice daily(1.5 g per dose).The treatment duration was 4 weeks.The main efficacy indicators[Chinese medicine(CM)syndrome score,blood pressure,and blood pressure control rate]and secondary efficacy indicators(blood lipids,uric acid,arachidonic acid,thromboxane B2,prostaglandin E2,and urinary microalbumin)before and after treatment between the two groups were compared.Safety and compliance analysis were conducted.Results A total of 129 patients completed the trial(65 in the control group and 64 in the experimental group).The blood pressure control rate in the experimental group was superior to the control group[65.63%(42/64)vs.43.08%(28/65),x2=6.606,P<0.05].Compared with baseline,both groups showed reductions in CM syndrome score,systolic blood pressure,and diastolic blood pressure after treatment(P<0.05),with the experimental group showing more significant improvement than the control group(P<0.05).Arachidonic acid and thromboxane B2 decreased in the experimental group(P<0.05),while prostaglandin E2 increased(P<0.05).Compared with the control group after treatment,arachidonic acid levels decreased in the experimental group(P<0.05).There were no adverse reactions in either group,and there was no statistically significant difference in compliance between the two groups(P>0.05).Conclusion TJT is safe and effective in treating grade 1 hypertension with Gan-Yang hyperactivity syndrome.(Chinese Clinical Trial Registry,No.ChiCTR-IIR-17011940).