NCT03542721

Brief Summary

The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515 (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 17, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 4, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

May 18, 2018

Last Update Submit

June 1, 2018

Conditions

Fatigue Symptom

Keywords

chronic fatigue symptomblood circulation

Outcome Measures

Primary Outcomes (1)

  • CIS(Checklist Individual Strength) less than or equal to 76

    Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks

    8weeks

Study Arms (2)

Placebo of DA-5515 Capsule

PLACEBO COMPARATOR

Placebo of DA-5515 (three times a day)

Drug: Placebo of DA-5515

DA-5515 Capsule

EXPERIMENTAL

Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day)

Drug: DA-5515

Interventions

DA-5515DRUG

Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)

Also known as: Circulan® Soft Capule
DA-5515 Capsule
Placebo of DA-5515DRUG

Placebo (three times a day)

Also known as: Placebo capsule
Placebo of DA-5515 Capsule

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rutherford's category 0/0 or Ⅰ/1
  • ABI \<1.0
  • CIS greater than 76
  • HADS less than or equal to 10
  • Subjects who have fatigue symptoms more than 1 month

You may not qualify if:

  • Subjects who have diseases that can cause fatigue
  • Subjects who are taking medication that can cause fatigue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • WhanSeok Choi

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran Seo

CONTACT

010-4547-1480seoran@dreamwiz.com

WhanSeok Choi

CONTACT

02-2258-6285fmchs@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 31, 2018

Study Start

January 17, 2018

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

June 4, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)