Skip to main content
OpenTrials
Completed

NCT Number: NCT02242461

Rhodiola Crenulata as an Adjunctive Therapy in COPD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Critical Care Medicine and Division of Pulmonary Medicine

Dawan, Ming-Lung Chuang, Taiwan

About this study

This is a single center, randomized, double-blind, placebo controlled clinical trial.

Eligibility criteria:

  • moderate-to-severe COPD patients
  • aged 40-80 years,
  • abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
  • no acute exacerbation of COPD,
  • clinically being stable for one month and longer,
  • not undergoing exercise training program.

Primary endpoint:

six-minute walk distance in meters at week 12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate-to-severe COPD patients
  • aged 40-80 years,
  • abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
  • no acute exacerbation of COPD,
  • clinically being stable for one month and longer,
  • not undergoing exercise training program.

Exclusion criteria

  • uncontrolled diabetes mellitus by plasma fasting sugar >200 mg/dl,
  • uremia or CKD stage 5,
  • chronic heart failureby NYFC III,
  • cerebrovascular disease,
  • uncontrolled anemia by Hb < 10 mg/dl,
  • active malignant diseases,
  • other hospitalized acute illness,
  • systemic prednisolone > 10 mg per day.

Treatment and study plan

Rhodiola placebo capsules

Drug

Corn starch

Rhodiola crenulata

Drug

Rhodiola Crenulata

Other names: Rhodiola

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2014
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.