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Caffeic Acid Tablets as a Second-line Therapy for ITP

NCT02351622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2016-04-20

No results posted yet for this study

Summary

The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

Interventions

DRUG

Caffeic acid

Oral administration of caffeic acid tablet 0.3g three times per day for 1 year

DRUG

Dexamethasone

Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.

DRUG

Placebo

Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.

Sponsors & Collaborators

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Qianfoshan Hospital

    collaborator OTHER

  • Anhui Medical University

    collaborator OTHER

  • Qingdao University

    collaborator OTHER

  • Shandong University

    lead OTHER

Principal Investigators

  • Ming Hou, MD, PhD · Shandong University Qilu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351622 on ClinicalTrials.gov