Efficacy and Safety of HuZhen Capsule for Treatment of Pa... | NCT02674776

Studies
Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout

NCT02674776

Sponsor

Quan Jiang

Status

Unknown status

Last Update Posted

Jun 20, 2016Estimated

Enrollment

480Estimated

Phase

Phase 3

Conditions

Acute Gout

Interventions

HuZhen Capsule
Placebo Capsule

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Jan 28, 2016

First Submission Date that Met QC Criteria

Feb 2, 2016

First Posted Date

Feb 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2016

Last Update Posted Date

Jun 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Quan Jiang, Director and Professor of Rheumatology Devision, Guang'anmen Hospital of China Academy of Chinese Medical SciencesSponsor-Investigator

Lead Sponsor

Quan JiangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.

Detailed Description

The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HuZhen Capsule	Experimental	The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.	Drug: HuZhen Capsule
Placebo Capsule	Placebo Comparator	Placebo appearance, content color and taste should be consistent with HuZhen Capsule.	Drug: Placebo Capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HuZhen Capsule	Drug	Patients should take 4 tablet once and 3 times per day for 3 days.	HuZhen Capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset		baseline,72 hours

Secondary Outcomes

Measure	Description	Time Frame
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention	Refer to the"Guidline for Clinical Study of New Chinese Medicines "	72 hours
Change in C-reactive protein (CRP) from baseline to 72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
Acute attack of gout no longer than 2 days.
Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
Age 18-65 years with informed consent.

Exclusion Criteria:

Chronic gouty arthritis.
Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
Anti-inflammatory medication for the treatment of acute gout.
Pregnant or breastfeeding women.
History of severe allergy, including diclofenac sodium.
Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
Fever ( T>38.5 ℃)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jiang Quan, Doctor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guang'anmen Hospital		Beijing	Beijing Municipality	100052	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided