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

NCT ID: NCT03542721

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fatigue Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo of DA-5515 Capsule

Placebo of DA-5515 (three times a day)

Group Type PLACEBO_COMPARATOR

Placebo of DA-5515

Intervention Type DRUG

Placebo (three times a day)

DA-5515 Capsule

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

Group Type EXPERIMENTAL

DA-5515

Intervention Type DRUG

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

Interventions

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DA-5515

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

Intervention Type DRUG

Placebo of DA-5515

Placebo (three times a day)

Intervention Type DRUG

Other Intervention Names

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Circulan® Soft Capule Placebo capsule

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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WhanSeok Choi

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ran Seo

Role: CONTACT

010-4547-1480

WhanSeok Choi

Role: CONTACT

02-2258-6285

Facility Contacts

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Ran Seo

Role: primary

010-4547-1480

Other Identifiers

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DA-5515

Identifier Type: -

Identifier Source: org_study_id

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