NCT01904695

Brief Summary

The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2013

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

July 14, 2013

Last Update Submit

September 4, 2016

Conditions

Primary HypertensionHypertension, Resistant to Conventional Therapy

Keywords

resistant hypertensioncausal inferencea chorot studyrecipe of removing both phlegm and blood stasis

Outcome Measures

Primary Outcomes (1)

  • Systolic (SBP) and diastolic (DBP) blood pressure reductions

    Before treatment, 8 weeks during treatment

Secondary Outcomes (3)

  • Cardiac event

    Before treatment, 24 weeks follow-up

  • Death incident

    Before treatment, 24 weeks follow-up

  • Scores for symptoms and signs

    Before treatment, 8 weeks during treatment

Other Outcomes (1)

  • Possible side effects and adverse reactions

    2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up

Study Arms (2)

Antihypertensive drugs & Herbs

EXPERIMENTAL

Thiazide diuretics and ACE inhibitor and β-blocker \& Herbs for 8 weeks

Drug: HerbsDrug: Antihypertensive drugs

Antihypertensive drugs

ACTIVE COMPARATOR

Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks

Drug: Antihypertensive drugs

Interventions

HerbsDRUG

Herbs 180ml by mouth every 12 hours for 8 weeks

Also known as: recipe of removing both phlegem and blood stasis
Antihypertensive drugs & Herbs
Antihypertensive drugsDRUG

Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks

Also known as: Thiazide diuretics and ACE inhibitor and β-blocker
Antihypertensive drugsAntihypertensive drugs & Herbs

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertension subjects, aged 18-70 years, blood pressure \> 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.

You may not qualify if:

  • Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

  • Yuwen Y, Liu YQ, Wang YP, Dai JG, Liu DS, Wang YX, Han XJ. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study. J Integr Med. 2015 Mar;13(2):122-8. doi: 10.1016/S2095-4964(15)60162-5.

    PMID: 25797643BACKGROUND

MeSH Terms

Conditions

Essential HypertensionHypertension Resistant to Conventional Therapy

Interventions

Antihypertensive AgentsSodium Chloride Symporter InhibitorsAngiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionDiureticsNatriuretic AgentsPhysiological Effects of DrugsProtease InhibitorsEnzyme Inhibitors

Study Officials

  • Ya YUWEN, PhD

    China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 14, 2013

First Posted

July 22, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)