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

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06093932
• Collaborator: China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital (Other), Suzhou Hosptial of Traditional Chinese Medicine (Other), China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital (Other), Shandong University of Traditional Chinese Medicine (Other)
• Enrollment: 100
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 50
• Patients Per Site: 20
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential	Drug: Songling Xuemaikang Capsules; Behavioral: Lifestyle intervention; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lifestyle intervention + Songling Xuemaikang Capsules Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks	Drug: Songling Xuemaikang Capsules; 3 capsules at a time, three times a day, duration: 12 weeks; Behavioral: Lifestyle intervention; everyday, duration: 12 weeks
Placebo Comparator: Lifestyle intervention + placebo Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks placebo, 3 capsules at a time, three times a day, duration: 12 weeks	Behavioral: Lifestyle intervention; everyday, duration: 12 weeks; Drug: Placebo; 3 capsules at a time, three times a day, duration: 12 weeks

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

1. Change from Baseline in the ba-PWV at 4,12 weeks [Baseline and Week 4,12]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

9. Change from Baseline in the BP load at 4,12 weeks [Baseline and Week 4,12]

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

10. Change from Baseline in the Official PP at 4,12 weeks [Baseline and Week 4,12]

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

11. Change from Baseline in the Official SBP at 4,12 weeks [Baseline and Week 4,12]

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

12. Change from Baseline in the Official DBP at 4,12 weeks [Baseline and Week 4,12]

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

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

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

14. Change from Baseline in the Home SBP at 4,12 weeks [Baseline and Week 4,12]

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

15. Change from Baseline in the Home DBP at 4,12 weeks [Baseline and Week 4,12]

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

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

    Proportion= Number of target patients/Total patients

17. Change from Baseline in the CIMT at 4,12 weeks [Baseline and Week 4,12]

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

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

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

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

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

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing	China	100091
2	Suzhou Hosptial of Traditional Chinese Medicine	Suzhou	Jiangsu	China	215002
3	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong	China	250013
4	China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital	Jining	Shandong	China	272000
5	China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital	Taiyuan	Shanxi	China	030024

Sponsors and Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences
• 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

Investigators

• Study Chair: Hao Xu, Prof., Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• ClinicalTrials.gov Identifier: NCT06093932
• Other Study ID Numbers: 2023XL012-3
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences: Songling Xuemaikang Capsules; Vascular remodeling; Grade 1 hypertension; Mild hypertension
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Oct 23, 2023