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Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation

Sponsor
Dong-A Pharmaceutical (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03542721
Collaborator
(none)
204
Enrollment
1
Location
2
Arms
22.4
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This study is conducting to assess the efficacy and safety of the DA-5515 (Circulan Soft Cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Placebo-controlled, Randomized, Double-blind, Parallel, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
Actual Study Start Date :
Jan 17, 2018
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo of DA-5515 Capsule

Placebo of DA-5515 (three times a day)

Drug: Placebo of DA-5515
Placebo (three times a day)
Other Names:
  • Placebo capsule

    		•
    Experimental: DA-5515 Capsule

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

    Drug: DA-5515
    Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)
    Other Names:
  • Circulan® Soft Capule

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CIS(Checklist Individual Strength) less than or equal to 76 [8weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Subjects who have diseases that can cause fatigue

    • Subjects who are taking medication that can cause fatigue

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul St. Mary's Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Dong-A Pharmaceutical

    Investigators

    • Principal Investigator: WhanSeok Choi, Seoul St. Mary's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT03542721
    Other Study ID Numbers:
    • DA-5515
    First Posted:
    May 31, 2018
    Last Update Posted:
    Jun 4, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong-A Pharmaceutical
    chronic fatigue symptom
    blood circulation
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of Jun 4, 2018