Rhodiola Crenulata as an Adjunctive Therapy in COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Drug: Rhodiola placebo capsules
* Drug: Rhodiola Crenulata


Participation Criteria
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Eligibility Criteria
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Inclusion 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Rhodiola placebo capsules<br>starch | Drug: Rhodiola placebo capsules<br>* Corn starch<br>|
| Experimental: Rhodiola Crenulata<br>Rhodiola Crenulata | Drug: Rhodiola Crenulata<br>* Rhodiola Crenulata<br>* Other names: Rhodiola;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six-minute walk distance in meters at week 12. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Rhodiola L., clinical trial, biomarkers, spirometry