Rhodiola Crenulata as an Adjunctive Therapy in COPD

NCT ID: NCT02242461

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rhodiola placebo capsules

starch

Group Type: PLACEBO_COMPARATOR

Rhodiola placebo capsules

Intervention Type: DRUG

Corn starch

Rhodiola Crenulata

Rhodiola Crenulata

Group Type: EXPERIMENTAL

Rhodiola Crenulata

Intervention Type: DRUG

Rhodiola Crenulata

Interventions

Rhodiola placebo capsules

Corn starch

Intervention Type: DRUG

Rhodiola Crenulata

Rhodiola Crenulata

Intervention Type: DRUG

Other Intervention Names

Rhodiola

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

GCRC

Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Lung Chuang

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine and Division of Pulmonary Medicine

Locations

Department of Critical Care Medicine and Division of Pulmonary Medicine

Dawan, Ming-Lung Chuang, Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 26098419 (View on PubMed)

Other Identifiers

CS11144

Identifier Type: -

Identifier Source: org_study_id