COPDPhase 2COPDNCT02242461
Rhodiola Crenulata as an Adjunctive Therapy in COPD
A Phase 2 study testing Rhodiola Crenulata in people with COPD, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Rhodiola Crenulata
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2012to Jul 2013
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate-to-severe COPD patients
- aged 40-80 years,
- abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
- no acute exacerbation of COPD,
- clinically being stable for one month and longer,
- not undergoing exercise training program.
Who cannot join
- uncontrolled diabetes mellitus by plasma fasting sugar >200 mg/dl,
- uremia or CKD stage 5,
- chronic heart failureby NYFC III,
- cerebrovascular disease,
- uncontrolled anemia by Hb < 10 mg/dl,
- active malignant diseases,
- other hospitalized acute illness,
- systemic prednisolone > 10 mg per day.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Critical Care Medicine and Division of Pulmonary Medicine
Dawan, Ming-Lung Chuang
About this study
Official title: Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease
We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality of life and exercise tolerance.
Read the detailed description
This is a single center, randomized, double-blind, placebo controlled clinical trial.
Eligibility criteria:
- moderate-to-severe COPD patients
- aged 40-80 years,
- abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
- no acute exacerbation of COPD,
- clinically being stable for one month and longer,
- not undergoing exercise training program.
Primary endpoint:
six-minute walk distance in meters at week 12.
- Conditions
- COPD
- Being tested
- Rhodiola placebo capsules, Rhodiola Crenulata
- Keywords
- COPD, Rhodiola L., clinical trial, biomarkers, spirometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhodiola placebo capsulesDrug
Corn starch
Rhodiola CrenulataDrug
Also called Rhodiola
Rhodiola Crenulata
| Study group | Role | What they receive |
|---|---|---|
| Rhodiola placebo capsules | Placebo comparator | starch Receives: Drug: Rhodiola placebo capsules |
| Rhodiola Crenulata | Experimental | Rhodiola Crenulata Receives: Drug: Rhodiola Crenulata |
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walk distance in meters at week 12.
Measured: 12 weeks
Secondary outcomes (1)
mid-arm circumference and triceps skin thickness, Borg scale, COPD assessment test score, St. George Respiratory disease questionnaire, hospital anxiety and depression scale(HADS) and maximum cardiopulmonary exercise test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
- Investigators
- Ming Lung Chuang, Principal investigator, Department of Critical Care Medicine and Division of Pulmonary Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242461
- Sponsor's protocol ID
- CS11144
- Acronym
- COPD
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chuang ML, Wu TC, Wang YT, Wang YC, Tsao TC, Wei JC, Chen CY, Lin IF. Adjunctive Treatment with Rhodiola Crenulata in Patients with Chronic Obstructive Pulmonary Disease--A Randomized Placebo Controlled Double Blind Clinical Trial. PLoS One. 2015 Jun 22;10(6):e0128142. doi: 10.1371/journal.pone.0128142. eCollection 2015.
PubMed 26098419
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02242461
- Acronym / sponsor ID
- COPD / CS11144
- Conditions
- COPD
- Keywords
- COPD, Rhodiola L., clinical trial, biomarkers, spirometry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Sep 2014 (estimated)
- 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.
We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality of life and exercise tolerance.
Detailed description
This is a single center, randomized, double-blind, placebo controlled clinical trial.
Eligibility criteria:
- moderate-to-severe COPD patients
- aged 40-80 years,
- abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
- no acute exacerbation of COPD,
- clinically being stable for one month and longer,
- not undergoing exercise training program.
Primary endpoint:
six-minute walk distance in meters at week 12.
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 |
|---|---|---|
| Rhodiola placebo capsules | Placebo comparator | Drug: Rhodiola placebo capsulesstarch |
| Rhodiola Crenulata | Experimental | Drug: Rhodiola CrenulataRhodiola Crenulata |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- moderate-to-severe COPD patients
- aged 40-80 years,
- abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
- no acute exacerbation of COPD,
- clinically being stable for one month and longer,
Key exclusion criteria (8 listed)
- uncontrolled diabetes mellitus by plasma fasting sugar >200 mg/dl,
- uremia or CKD stage 5,
- chronic heart failureby NYFC III,
- cerebrovascular disease,
- uncontrolled anemia by Hb < 10 mg/dl,
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 |
|---|---|---|
| Rhodiola placebo capsulesCorn starch | Drug | Rhodiola placebo capsules |
| Rhodiola CrenulataAlso: RhodiolaRhodiola Crenulata | Drug | Rhodiola Crenulata |
Primary outcome
six-minute walk distance in meters at week 12.
Time frame: 12 weeks
1 secondary outcome
mid-arm circumference and triceps skin thickness, Borg scale, COPD assessment test score, St. George Respiratory disease questionnaire, hospital anxiety and depression scale(HADS) and maximum cardiopulmonary exercise test
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Derived from this study: PubMed 26098419Chuang ML, Wu TC, Wang YT, Wang YC, Tsao TC, Wei JC, Chen CY, Lin IF. Adjunctive Treatment with Rhodiola Crenulata in Patients with Chronic Obstructive Pulmonary Disease--A Randomized Placebo Controlled Double Blind Clinical Trial. PLoS One. 2015 Jun 22;10(6):e0128142. doi: 10.1371/journal.pone.0128142. eCollection 2015.
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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.
Ming Lung Chuang principal investigator
Department of Critical Care Medicine and Division of Pulmonary Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rhodiola Crenulata in people with COPD, run by Chung Shan Medical University at 1 site in Taiwan.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 17 Sep 2014. 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walk distance in meters at week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242461, which also lists 1 linked publication.
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 17 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.