Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-05 @ 6:26 PM
Study NCT ID:
NCT06093932
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2023-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D066253', 'term': 'Vascular Remodeling'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606146', 'term': 'songling xuemaikang'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-17', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the ba-PWV at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the skin capillary density(SCD) at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Mean 24h Diastolic Blood Pressure at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Mean daytime Systolic Blood Pressure at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Mean daytime Diastolic Blood Pressure at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Mean nighttime Systolic Blood Pressure at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Mean nighttime Diastolic Blood Pressure at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Mean 24h PP at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the BP load at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Official PP at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Official SBP at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Official DBP at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Official BP Compliance Rate at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Home SBP at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Home DBP at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Proportion of patients with grade 2 or higher hypertension or target organ damage at 12 weeks', 'timeFrame': 'Week 12', 'description': 'Proportion= Number of target patients/Total patients'}, {'measure': 'Change from Baseline in the CIMT at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Hypertension Symptom Quantitative Score at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Patient Health Questionnaire-9 Quantitative Score at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}, {'measure': 'Change from Baseline in the Generalized Anxiexy Disorde-7 Quantitative Score at 4,12 weeks', 'timeFrame': 'Baseline and Week 4,12', 'description': 'Change=(Week 12 value- Baseline value) and (Week 4 value- Baseline value)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Songling Xuemaikang Capsules', 'Vascular remodeling', 'Grade 1 hypertension', 'Mild hypertension'], 'conditions': ['Hypertension,Essential']}, 'referencesModule': {'references': [{'pmid': '33019798', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40770317', 'type': 'DERIVED', 'citation': 'Liu Q, Yu L, Zhang Z, Zhuang Z, Tian W, Wang A, Xu H. The effects of Songling Xuemaikang capsule on vascular remodeling of stage 1 hypertension: a multicenter, randomized placebo-controlled trial protocol. BMC Complement Med Ther. 2025 Aug 6;25(1):300. doi: 10.1186/s12906-025-05038-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension.\n2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension.\n3. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 35-65 years old, male or female;\n* Grade 1 essential hypertension;\n* Taking no antihypertensive drugs or taking antihypertensive drugs irregularly in the past ;\n* Sign the informed consent;\n\nExclusion Criteria:\n\n* Significant liver and kidney dysfunction, ALT and AST upper the twice of normal range, Scr≥2.0mg/dl, eGFR\\<60ml/(min·1. 73m2);\n* Gastrointestinal diseases, which may affect drug absorption;\n* Be allergic to the clinical trial medicine;\n* Pregnant or breastfeeding women, men who plan to give birth within half a year;\n* Combined with other serious primary diseases or malignant tumors;\n* Hyperlipidemia with or without taking lipid-lowering drugs;\n* Combined with left ventricular hypertrophy, ABI \\< 0.9, CIMT ≥ 0.9mm or atherosclerotic plaque;\n* Hypertensive comorbidities (cerebrovascular disease, other cardiovascular diseases, renal disease, peripheral artery disease, retinopathy, diabetes);\n* Other serious conditions in which is not fit for the study.'}, 'identificationModule': {'nctId': 'NCT06093932', 'acronym': 'ESCIHP', 'briefTitle': 'Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Efficacy of Songling Xuemaikang Capsules on Grade 1 Hypertension: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2023XL012-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention + Songling Xuemaikang Capsules', 'description': '1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks\n2. Songling Xuemaikang Capsules, 3 capsules at a time, three times a day, duration: 12 weeks', 'interventionNames': ['Drug: Songling Xuemaikang Capsules', 'Behavioral: Lifestyle intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lifestyle intervention + placebo', 'description': '1. Therapeutic Hypertensive Lifestyle Modifications, everyday, duration: 12 weeks\n2. placebo, 3 capsules at a time, three times a day, duration: 12 weeks', 'interventionNames': ['Behavioral: Lifestyle intervention', 'Drug: Placebo']}], 'interventions': [{'name': 'Songling Xuemaikang Capsules', 'type': 'DRUG', 'description': '3 capsules at a time, three times a day, duration: 12 weeks', 'armGroupLabels': ['Lifestyle intervention + Songling Xuemaikang Capsules']}, {'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'everyday, duration: 12 weeks', 'armGroupLabels': ['Lifestyle intervention + Songling Xuemaikang Capsules', 'Lifestyle intervention + placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 capsules at a time, three times a day, duration: 12 weeks', 'armGroupLabels': ['Lifestyle intervention + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Anlu Wang, Doctor', 'role': 'CONTACT', 'email': 'wwanganlu@126.com', 'phone': '010-62835342'}], 'facility': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '215002', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongqi Bao, Prof.', 'role': 'CONTACT', 'email': 'brq168@126.com', 'phone': '0512-65222220'}], 'facility': 'Suzhou Hosptial of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Lu, Prof.', 'role': 'CONTACT', 'email': '243173005@qq.com', 'phone': '0531-68616063'}], 'facility': 'Affiliated Hospital of Shandong University of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '272000', 'city': 'Jining', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiyang Zhu, MD', 'role': 'CONTACT', 'email': 'zhuzhy@usx.edu.cn', 'phone': '0537-6551859'}], 'facility': 'China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital', 'geoPoint': {'lat': 35.405, 'lon': 116.58139}}, {'zip': '030024', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhigeng Hu, Prof.', 'role': 'CONTACT', 'email': '13835172121@126.com', 'phone': '0351-8618099'}], 'facility': 'China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Anlu Wang, Doctor', 'role': 'CONTACT', 'email': 'wwanganlu@126.com', 'phone': '010-62835342'}, {'name': 'Qiyu Liu, Doctor', 'role': 'CONTACT', 'email': 'liuqy9307@163.com', 'phone': '010-18810722937'}], 'overallOfficials': [{'name': 'Hao Xu, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Academy of Chinese Medical Sciences Xiyuan Hospital Shanxi Hospital', 'class': 'UNKNOWN'}, {'name': 'Suzhou Hosptial of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'China Academy of Chinese Medical Sciences Xiyuan Hospital Jining Hospital', 'class': 'UNKNOWN'}, {'name': 'Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}