A Randomized， Double-blind， Placebo-controlled Clinical Trial of Tengshen Granules for Treatment of Grade 1 Hypertension
10.13422/j.cnki.syfjx.20251724
- VernacularTitle:藤参颗粒治疗1级高血压病随机、双盲、安慰剂平行对照临床试验
- Author:
Yuru PENG
1
;
Jiaming HUAN
1
;
Laiyun XIN
2
;
Zhenyuan WANG
2
;
Cong WANG
2
;
Yunlun LI
1
Author Information
1. Shandong University of Traditional Chinese Medicine（TCM）， Jinan 250355， China
2. Affiliated Hospital of Shandong University of TCM， Jinan 250014，China
- Publication Type:Journal Article
- Keywords:
Tengshen granules;
grade 1 hypertension;
syndrome of severe liver heat and hyperactive Yang combined with mild kidney Yin deficiency;
randomized， double-blind， controlled trial
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(21):168-176
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of Tengshen Granules in the treatment of grade 1 hypertension with the syndrome of severe liver heat and hyperactive Yang combined with mild kidney Yin deficiency. MethodsA total of 120 patients with grade 1 hypertension presenting with severe liver heat and hyperactive Yang combined with mild kidney Yin deficiency were enrolled in a randomized， double-blind， placebo-controlled， parallel-group clinical trial. Patients were randomly assigned to the observation group （Tengshen granules） and the control group （placebo）， with 60 cases in each group. On the basis of lifestyle intervention， treatment was administered for 8 weeks followed by a 2-month follow-up. During the study period， traditional Chinese medicine （TCM） syndrome scores， blood pressure， antihypertensive efficacy， blood pressure control rate， and other indicators were recorded and analyzed， and safety was evaluated. ResultsA total of 114 patients completed the trial， including 57 in the control group and 57 in the observation group. Compared with baseline， TCM syndrome scores， systolic blood pressure， and diastolic blood pressure in the observation group were significantly reduced after treatment （P<0.01）. Compared with the control group after treatment， systolic blood pressure in the observation group was lower from week 4 of medication （P<0.05）， and this difference persisted until 2 months after drug discontinuation. For diastolic blood pressure， the observation group was superior to the control group at week 8 （P<0.01）， with no statistically significant differences at other time points. Regarding syndrome improvement， the TCM syndrome scores for severe liver heat and hyperactive Yang combined with mild kidney Yin deficiency showed significant improvement at weeks 6 and 8 of treatment， with the observation group superior to the control group （P<0.05）. During the 1-month follow-up after drug discontinuation， the syndrome scores in the observation group remained lower than those in the control group （P<0.01）. The total effective rate of antihypertensive efficacy in the observation group was higher than that in the control group （χ2=11.389， P<0.05）. In addition， the level of urinary microalbumin in the observation group was lower after treatment than before treatment （P<0.05）. ConclusionTengshen granules demonstrate significant clinical efficacy and good safety in the treatment of grade 1 hypertension with severe liver heat and hyperactive Yang combined with mild kidney Yin deficiency. They can effectively reduce blood pressure and improve related TCM syndrome manifestations.
