Rhodiola Crenulata as an Adjunctive Therapy in COPD

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Keywords

attention deficit hyperactivity disorder

Abstract

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.

Dates

Last Verified:	08/31/2014
First Submitted:	09/03/2014
Estimated Enrollment Submitted:	09/15/2014
First Posted:	09/16/2014
Last Update Submitted:	09/15/2014
Last Update Posted:	09/16/2014
Actual Study Start Date:	04/30/2012
Estimated Primary Completion Date:	06/30/2013
Estimated Study Completion Date:	06/30/2013

Condition or disease

COPD

Intervention/treatment

Drug: Rhodiola placebo capsules

Drug: Rhodiola Crenulata

Phase

Phase 2

Arm Groups

Arm	Intervention/treatment
Placebo Comparator: Rhodiola placebo capsules starch	Drug: Rhodiola placebo capsules Corn starch
Experimental: Rhodiola Crenulata Rhodiola Crenulata	Drug: Rhodiola Crenulata Rhodiola Crenulata

Eligibility Criteria

Ages Eligible for Study	40 Years To 40 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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.

Outcome

Primary Outcome Measures

1. six-minute walk distance in meters at week 12. [12 weeks]

Secondary Outcome Measures

1. 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]