NCT02359396

Brief Summary

This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and pharmacokinetics profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

January 27, 2015

Last Update Submit

August 19, 2015

Conditions

Functional ConstipationGastrointestinal Disorders

Keywords

Randomized open-label studyChinese HerbalConstipation/drug therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability among Three Doses of MZRW

    12 hours

Secondary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC)

    12 hours

  • the changes of plasma concentrations of MZRW ingredients in different time points

    12 hours

Study Arms (3)

5.0g of MZRW

EXPERIMENTAL

The participants will receive 5.0g of MZRW at 9 am .

Drug: MZRW

7.5g of MZRW

EXPERIMENTAL

The participants will receive 7.5g of MZRW at 9 am.

Drug: MZRW

10g of MZRW

EXPERIMENTAL

The participants will receive 10g of MZRW at 9 am.

Drug: MZRW

Interventions

MZRWDRUG

MZRWs is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo). All MZRW granules will be prepared by PuraPharm International (H.K.) Limited. The entire manufacturing process, from authenticating the raw materials to the final products, is in strict compliance with the standards of Good Manufactory Practice (GMP) and Chinese Pharmacopoeia.

10g of MZRW5.0g of MZRW7.5g of MZRW

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Zhao Xiang Bian, MD, Ph. D

    School of Chinese Medicine, Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor, Director of Clinical Division,

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 10, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-02

Locations

CN(1)