Rhodiola Crenulata as an Adjunctive Therapy in COPD
COPD
1 other identifier
interventional
57
1 country
1
Brief 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 of life and exercise tolerance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 17, 2014
CompletedSeptember 17, 2014
September 1, 2014
1.2 years
September 4, 2014
September 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
six-minute walk distance in meters at week 12.
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
12 weeks
Study Arms (2)
Rhodiola placebo capsules
PLACEBO COMPARATORstarch
Rhodiola Crenulata
EXPERIMENTALRhodiola Crenulata
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Critical Care Medicine and Division of Pulmonary Medicine
Dawan, Ming-Lung Chuang, Taiwan
Related Publications (1)
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.
PMID: 26098419DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Lung Chuang
Department of Critical Care Medicine and Division of Pulmonary Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine
Study Record Dates
First Submitted
September 4, 2014
First Posted
September 17, 2014
Study Start
May 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
September 17, 2014
Record last verified: 2014-09