Introduction Tetramethylpyrazine (TMP), one of the active ingredients from the traditional Chinese herbal medicine Rhizoma Chuanxiong (Chuanxiong), has been clinically used for the prevention and treatment on cardiovascular diseases. The benefits of TMP are largely attributed to its anti-oxidize and vasodilative activities. However, the efficacy of TMP in the treatment of pulmonary hypertension(PH) is unknown, in this study, we hypothesized that TMP treatment has a therapeutic effect on PH patients.
Background: Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH.Methods:A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) At rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) Type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-minute walk distance between 100 and 450 meters; (v) lung function at level II, III, or IV according to WHO classification. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks, and symptoms and patient compliance will be recorded.Discussion:We aim to determine the efficacy and safety of TMP for the treatment of PH.Study registration:ChiCTR1800018664, http://www.chictr.org.cn/edit.aspx?pid=31565&htm=4 (registered on 2 October 2018).
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