Rhodiola Crenulata as an Adjunctive Therapy in COPD

COPD Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242461
• Other study ID #: CS11144
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2014
• Last updated: September 16, 2014
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan:Chung Shan Medical University Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Rhodiola placebo capsules
Corn starch
• Rhodiola Crenulata
Rhodiola Crenulata

Locations

Country	Name	City	State
Taiwan	Department of Critical Care Medicine and Division of Pulmonary Medicine	Taiwan	Ming-Lung Chuang

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six-minute walk distance in meters at week 12.		12 weeks	Yes
Secondary	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	Yes