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

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ClinicalTrials.gov Identifier: NCT03542721
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical

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
Fatigue Symptom Drug: DA-5515 Drug: Placebo of DA-5515 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 17, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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 Name: 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 Name: Circulan® Soft Capule




Primary Outcome Measures :
  1. CIS(Checklist Individual Strength) less than or equal to 76 [ Time Frame: 8weeks ]
    Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542721


Contacts
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Contact: Ran Seo 010-4547-1480 seoran@dreamwiz.com
Contact: WhanSeok Choi 02-2258-6285 fmchs@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ran Seo    010-4547-1480    seoran@dreamwiz.com   
Sponsors and Collaborators
Dong-A Pharmaceutical
Investigators
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Principal Investigator: WhanSeok Choi Seoul St. Mary's Hospital

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Responsible Party: Dong-A Pharmaceutical
ClinicalTrials.gov Identifier: NCT03542721     History of Changes
Other Study ID Numbers: DA-5515
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Fatigue
Signs and Symptoms