Study protocol was approved by the Jilin Chinese Medical Hospital. Protocol summaries were reviewed by the participants, and written consent was obtained on the day of the study.
A total of 51 participants (39–57 years) as a group who met the inclusion criteria were enrolled, their clinical BP measurements and blood samples were taken, and the ABPM device was attached at the next visit. Out of the 51 participants, 10 volunteers (39–46 years) were selected as the subgroup. In this subgroup, BP data were compared with those simultaneously recorded from the radial artery of the same side. Intra-arterial BP was recorded 15 minutes after insertion of the radial artery catheter. During a 1-hour (during 08:30–10:00 am) period when the participants were lying quietly, BP was measured by the two methods (resting conditions).
The day after completion of the 24-hour BP recording, the ABPM device was collected. After the baseline examination, each enrolled patient participated in a session lasting 24 hours, during which Yongquan point (K1) of both sides were fomented with a mixture of Chinese herbs: Fu Zi (Radix Aconiti Lateralis Preparata) 5 g, Wu Zhuyu (Fructus Evodiae) 5 g, Chong Yuzi (Fructus Leonuri) 5 g, Luo Buma (Apocynum venetum) 5 g, and Tou Gucao (Herba Speranskiae Tuberculatae) 10 g in dry powdered form were dissolved in fresh warm water (20 mL, 35°). Yongquan point (K1) was identified according to traditional methods, located on the mid-line of the sole of the foot, 2/3 of the way forward from the back of the heel. BP recording over 24 hours was repeated the day after the therapy.
The sleep and wake-up times were reported by participants and recorded for further calculations. Daytime and nighttime were defined as from wake-up to sleep time and from sleep to wake-up time, respectively, for each participant. No major changes in hypotensive drugs had taken place during the 1 month prior to the study, and no alteration was made throughout the study.
The primary end points for clinical efficacy were the differences between baseline and post-treatment ABPM measurements.