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RecruitingNCT06093932ESCIHPUpdated Aug 20, 2024

Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial

A Phase 4 interventional study of Songling Xuemaikang Capsules and Lifestyle intervention in Hypertension,Essential, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Recruiting at 5 sites in China. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Hypertension,Essential

Keywords

  • Songling Xuemaikang Capsules
  • Vascular remodeling
  • Grade 1 hypertension
  • Mild hypertension
03

In context

Essential Hypertension

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 100 is below the median of 144 across 406 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 43 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;

Exclusion criteria

Exclusion Criteria:

  • Significant liver and kidney dysfunction, and AST upper the twice of normal range, Scr≥2.0mg/dl, \<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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Lifestyle intervention + Songling Xuemaikang Capsules

    1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks

    Drug: Songling Xuemaikang Capsules · Behavioral: Lifestyle intervention

  • Placebo comparator
    Lifestyle intervention + placebo

    1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks 2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks

    Behavioral: Lifestyle intervention · Drug: Placebo

Interventions

  • DrugSongling Xuemaikang Capsules

    3 capsules at a time, three times a day, duration: 12 weeks

  • BehavioralLifestyle intervention

    everyday, duration: 12 weeks

  • DrugPlacebo

    3 capsules at a time, three times a day, duration: 12 weeks

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

Secondary outcomes

  1. Change from Baseline in the ba-PWV at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  2. Change from Baseline in the skin capillary density(SCD) at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  3. Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  4. Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  5. Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  6. Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  7. Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  8. Change from Baseline in the Mean 24h PP at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  9. Change from Baseline in the BP load at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  10. Change from Baseline in the Official PP at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  11. Change from Baseline in the Official SBP at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  12. Change from Baseline in the Official DBP at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  13. Change from Baseline in the Official BP Compliance Rate at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  14. Change from Baseline in the Home SBP at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  15. Change from Baseline in the Home DBP at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  16. Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks

    Proportion= Number of target patients/Total patients

    Time frame: Week 12

  17. Change from Baseline in the CIMT at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  18. Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  19. Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

  20. Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks

    Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)

    Time frame: Baseline and Week 4,12

07

Study locations

1 of 5 sites recruiting
  • Xiyuan Hospital of China Academy of Chinese Medical Sciences
    Beijing, Beijing 100091, China
    Recruiting
  • Suzhou Hosptial of Traditional Chinese Medicine
    Suzhou, Jiangsu 215002, China
    Not yet recruiting
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    Jinan, Shandong 250013, China
    Not yet recruiting
  • China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital
    Jining, Shandong 272000, China
    Not yet recruiting
  • China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital
    Taiyuan, Shanxi 030024, China
    Not yet recruiting
08

References and documents

Publications

  • Zhang DY, Cheng YB, Guo QH, Shan XL, Wei FF, Lu F, Sheng CS, Huang QF, Yang CH, Li Y, Wang JG. Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1821-1830. doi: 10.1161/CIRCULATIONAHA.120.046685. Epub 2020 Oct 6. PubMed 33019798 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Dec 2024, 8 months after the start.

Of 22 phase 4 interventional studies under Essential Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 36. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2023
First posted
Oct 23, 2023
StartActual
Apr 7, 2024
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2027
Last update
Aug 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06093932
Lead sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital, Suzhou Hosptial of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital, Shandong University of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Apr 7, 2024
Primary completion
Dec 2024 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 20, 2024

Study contacts

Anlu Wang, Doctor
Contact
wwanganlu@126.com
010-62835342
Qiyu Liu, Doctor
Contact
liuqy9307@163.com
010-18810722937
Hao Xu, Prof.
study chair · Xiyuan Hospital of China Academy of Chinese Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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