Fatigue SymptomPhase 4NCT03542721
Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
A Phase 4 study testing DA-5515 in people with Fatigue Symptom, run by Dong-A Pharmaceutical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Fatigue Symptom
- What is being tested?
- DA-5515
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2018to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects who have diseases that can cause fatigue
- Subjects who are taking medication that can cause fatigue
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul
Ran Seo, 010-4547-1480, seoran@dreamwiz.com
About this study
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
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.
Read the 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.
- Conditions
- Fatigue Symptom
- Being tested
- DA-5515, Placebo of DA-5515
- Keywords
- chronic fatigue symptom, blood circulation
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5515Drug
Also called Circulan® Soft Capule
Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)
Placebo of DA-5515Drug
Also called Placebo capsule
Placebo (three times a day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo of DA-5515 Capsule | Placebo comparator | Placebo of DA-5515 (three times a day) Receives: Drug: Placebo of DA-5515 |
| DA-5515 Capsule | Experimental | Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day) Receives: Drug: DA-5515 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start17 Jan 2018
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WhanSeok Choi, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542721
- Sponsor's protocol ID
- DA-5515
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03542721
- Acronym / sponsor ID
- DA-5515
- Conditions
- Fatigue Symptom
- Keywords
- chronic fatigue symptom, blood circulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Dong-A PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo of DA-5515 Capsule | Placebo comparator | Drug: Placebo of DA-5515Placebo of DA-5515 (three times a day) |
| DA-5515 Capsule | Experimental | Drug: DA-5515Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day) |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects who have diseases that can cause fatigue
- Subjects who are taking medication that can cause fatigue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-5515Also: Circulan® Soft CapuleCrataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day) | Drug | DA-5515 Capsule |
| Placebo of DA-5515Also: Placebo capsulePlacebo (three times a day) | Drug | Placebo of DA-5515 Capsule |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WhanSeok Choi principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DA-5515 in people with Fatigue Symptom, run by Dong-A Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Seo (010-4547-1480, seoran@dreamwiz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIS(Checklist Individual Strength) less than or equal to 76 (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.