Rhodiola Crenulata as an Adjunctive Therapy in COPD

Chung Shan Medical University

Status and phase: Completed; Phase 2

Conditions: COPD

Treatments: Drug: Rhodiola placebo capsules; Drug: Rhodiola Crenulata

Study type: Interventional

Funder types: Other

Identifiers

NCT02242461

CS11144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Rhodiola placebo capsules

Placebo Comparator group

Description:

starch

Treatment:

Drug: Rhodiola placebo capsules

Rhodiola Crenulata

Experimental group

Description:

Rhodiola Crenulata

Treatment:

Drug: Rhodiola Crenulata