Rhodiola Crenulata as an Adjunctive Therapy in COPD

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02242461

Acronym

COPD

Enrollment

Registered

2014-09-17

Start date

2012-05-31

Completion date

2013-07-31

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, Rhodiola L., clinical trial, biomarkers, spirometry

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.

Detailed description

This is a single center, randomized, double-blind, placebo controlled clinical trial. Eligibility criteria: 1. moderate-to-severe COPD patients 2. aged 40-80 years, 3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption, 4. no acute exacerbation of COPD, 5. clinically being stable for one month and longer, 6. not undergoing exercise training program. Primary endpoint: six-minute walk distance in meters at week 12.

Interventions

DRUGRhodiola placebo capsules

Corn starch

DRUGRhodiola Crenulata

Rhodiola Crenulata

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. moderate-to-severe COPD patients 2. aged 40-80 years, 3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption, 4. no acute exacerbation of COPD, 5. clinically being stable for one month and longer, 6. not undergoing exercise training program.

Exclusion criteria

1. uncontrolled diabetes mellitus by plasma fasting sugar \>200 mg/dl, 2. uremia or CKD stage 5, 3. chronic heart failureby NYFC III, 4. cerebrovascular disease, 5. uncontrolled anemia by Hb \< 10 mg/dl, 6. active malignant diseases, 7. other hospitalized acute illness, 8. systemic prednisolone \> 10 mg per day.

Design outcomes

Primary

Measure	Time frame
six-minute walk distance in meters at week 12.	12 weeks

Secondary

Measure	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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026