BACKGROUND:Despite a recent American Heart Association (AHA) consensus statement emphasizing the importance of resistant hypertension (RH), its control is stil a chal enge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is stil unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH. METHODS/DESIGN:A prospective cohort study wil be conducted in two ifrst-class hospitals of traditional Chinese medicine (TCM). Eligible RH patients wil be classiifed as the experimental group (n=100) and the control group (n=100) based on the interventions they receive. Participants taking antihypertensive agents and the Chinese herbal formula wil be in the experimental group and those taking antihypertensive agents alone wil be in the control group. The whole study wil last 24 weeks, including an 8-week observation and fol ow-up at 24 weeks. The primary outcomes, assessed against patient baseline conditions, wil be the reduction of systolic blood pressure and diastolic blood pressure as wel as changes in TCM symptoms and signs. These outcomes wil be assessed at weeks 2, 4, 6, and 8. The reductions of blood pressure wil also be assessed at week 24. Cardiac events and mortality rate wil be secondary outcomes and wil be assessed at weeks 8 and 24. Any adverse reactions wil be recorded during the study. The causal inference method wil be used to assess the effectiveness of the inclusion of TCM herbal medicine in the management of patients with RH. DISCUSSION:This study wil determine whether the Chinese herbal formula is helpful for RH patients treated with antihypertensive agents and the ifndings wil provide a basis for further conifrmatory studies. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identiifer NCT01904695.