A Phase 4 interventional study of Yufeng Ningxin tablets and Placebo in Hypertension and Essential (Primary) Hypertension, sponsored by Beijing Anzhen Hospital. Recruiting at 16 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Beijing Anzhen Hospital · Phase 4, Interventional, and Treatment
Yufeng Ningxin, a traditional Chinese medicine, has demonstrated potential antihypertensive effects in animal studies and small clinical trials, but has not yet been rigorously evaluated in large randomized clinical trials. Here, the investigators conducted a double-blind, randomized controlled trial to assess the efficacy and safety of Yufeng Ningxin tablets in patients with hypertension.
Exclusion Criteria:
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Drug: Placebo
Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks.
Drug: Yufeng Ningxin tablets
Participants will receive Yufeng Ningxin tablets (0.28 g per tablet), taken as 5 tablets per dose, 3 times daily for 8 weeks.
Participants will receive a placebo matched to Yufeng Ningxin, taken as 5 tablets per dose, 3 times daily for 8 weeks.
Change from baseline in office SBP at Week 8
Time frame: 8 weeks from treatment initiation.
Change from baseline in office DBP at Week 8
Time frame: 8 weeks from treatment initiation.
Change from baseline in mean 24-hour ambulatory SBP/DBP at Week 8
Time frame: 8 weeks from treatment initiation.
Change from baseline in mean daytime ambulatory SBP/DBP at Week 8
Time frame: 8 weeks from treatment initiation.
Change from baseline in mean nighttime ambulatory SBP/DBP at Week 8
Time frame: 8 weeks from treatment initiation.
Change from baseline in Headache Impact Test-6 (HIT-6) score at Week 8.
The Headache Impact Test-6 (HIT-6), a 6-item questionnaire, will be used as part of the evaluation for headache symptoms to assess the impact of headaches on daily life. Each item is scored as 6 (never), 8 (rarely), 10 (sometimes), 11 (very often), or 13 (always) points. Total scores range from 36 to 78, with higher scores indicating a greater impact (worse outcome). The "change from baseline" is calculated as the score at Week 8 minus the score at baseline.
Time frame: 8 weeks from treatment initiation.
Change from baseline in Headache Disability Index (HDI) score at Week 8.
The Headache Disability Index (HDI), a 25-item tool designed to assess the impact of headache on daily activities and emotional well-being, will be used as part of the evaluation for headache symptoms. Each item is scored as 4 (yes), 2 (sometimes), or 0 (no). The total score ranges from 0 to 100, where higher scores indicate greater headache-related disability (worse outcome). The "change from baseline" is calculated as the score at Week 8 minus the score at baseline.
Time frame: 8 weeks from treatment initiation.
Change from baseline in species-level relative abundance of gut microbiota assessed by metagenomic shotgun sequencing at Week 8
The species-level relative abundance (%) of the gut microbiota will be analyzed using metagenomic shotgun sequencing of fecal samples.
Time frame: 8 weeks from treatment initiation.
Change from baseline in alpha-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8
Alpha-diversity: Evaluated by the Shannon index to measure community richness and evenness.
Time frame: 8 weeks from treatment initiation.
Change from baseline in beta-diversity of gut microbiota assessed by metagenomic shotgun sequencing at Week 8.
Beta-diversity: Evaluated by Bray-Curtis dissimilarity to assess structural differences between microbial communities.
Time frame: 8 weeks from treatment initiation.
Change from baseline in functional profile of gut microbiota assessed by metagenomic shotgun sequencing at Week 8.
Functional profile: The characterization of gut microbial functions based on databases such as KEGG (Kyoto Encyclopedia of Genes and Genomes) and MetaCyc.
Time frame: 8 weeks from treatment initiation.
Change from baseline in plasma and fecal metabolomic profiles at Week 8
Time frame: 8 weeks from treatment initiation.
Change from baseline in total cholesterol concentration at Week 8.
The serum concentration of total cholesterol (TC) will be measured in a certified clinical laboratory.
Time frame: 8 weeks from treatment initiation.
Change from baseline in triglycerides concentration at Week 8.
The serum concentration of triglycerides (TG) will be measured in a certified clinical laboratory.
Time frame: 8 weeks from treatment initiation.
Change from baseline in low-density lipoprotein cholesterol concentration at Week 8.
The serum concentration of low-density lipoprotein cholesterol (LDL-C) will be measured in a certified clinical laboratory.
Time frame: 8 weeks from treatment initiation.
Change from baseline in high-density lipoprotein cholesterol concentration at Week 8.
The concentration of high-density lipoprotein cholesterol (HDL-C) will be measured in a certified clinical laboratory.
Time frame: 8 weeks from treatment initiation.
Change from baseline in the fasting blood glucose concentration at Week 8.
This outcome measure assesses the change in the fasting blood glucose concentration. All assessments are performed in a certified clinical laboratory.
Time frame: 8 weeks from treatment initiation.
Incidence of a composite safety outcome (including all-cause mortality, hospitalizations, emergency visits, and adverse events) during the 8-week period.
This composite outcome measure tracks the overall safety profile of the intervention. It is defined as the number of participants experiencing at least one of the following safety-related events: (1) all-cause mortality; (2) hospitalizations or emergency visits; (3) adverse events.
Time frame: 8 weeks from treatment initiation.
Plan to share: No
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Beijing Anzhen Hospital