NCT06093932 Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
| NCT ID | NCT06093932 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences |
| Condition | Hypertension,Essential |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-07 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-04-07 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is: 1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension. 2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension. 3. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.
Eligibility Criteria
Inclusion Criteria: * Age between 35-65 years old, male or female; * Grade 1 essential hypertension; * Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ; * Sign the informed consent; Exclusion Criteria: * Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR\<60ml/(min·1. 73m2); * Gastrointestinal diseases, which may affect drug absorption; * Be allergic to the clinical trial medicine; * Pregnant or breastfeeding women, men who plan to give birth within half a year; * Combined with other serious primary diseases or malignant tumors; * Hyperlipidemia with or without taking lipid-lowering drugs; * Combined with left ventricular hypertrophy, ABI \< 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque; * Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes); * Other serious conditions in which is not fit for the study.
Contact & Investigator
Hao Xu, Prof.
STUDY CHAIR
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Frequently Asked Questions
Who can join the NCT06093932 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 65 Years, studying Hypertension,Essential. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06093932 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06093932 currently recruiting?
Yes, NCT06093932 is actively recruiting participants. Contact the research team at wwanganlu@126.com for enrollment information.
Where is the NCT06093932 trial being conducted?
This trial is being conducted at Beijing, China, Suzhou, China, Jinan, China, Jining, China and 1 additional location.
Who is sponsoring the NCT06093932 clinical trial?
NCT06093932 is sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. The principal investigator is Hao Xu, Prof. at Xiyuan Hospital of China Academy of Chinese Medical Sciences. The trial plans to enroll 100 participants.