Rhodiola Crenulata as an Adjunctive Therapy in COPD

Phase 2

Completed

• Conditions: COPD
• Interventions: Drug: Rhodiola placebo capsules; Drug: Rhodiola Crenulata

• Registration Number: NCT02242461
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-17
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhodiola placebo capsules	Rhodiola placebo capsules	starch
Rhodiola Crenulata	Rhodiola Crenulata	Rhodiola Crenulata

Primary Outcome Measures

Name	Time	Method
six-minute walk distance in meters at week 12.	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Critical Care Medicine and Division of Pulmonary Medicine; 🇨🇳 Taiwan, Ming-Lung Chuang, Taiwan