Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT02242461
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2014-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhodiola Crenulata as an Adjunctive Therapy in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-16', 'studyFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'six-minute walk distance in meters at week 12.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD, Rhodiola L., clinical trial, biomarkers, spirometry'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '26098419', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'This is a single center, randomized, double-blind, placebo controlled clinical trial.\n\nEligibility criteria:\n\n1. moderate-to-severe COPD patients\n2. aged 40-80 years,\n3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,\n4. no acute exacerbation of COPD,\n5. clinically being stable for one month and longer,\n6. not undergoing exercise training program.\n\nPrimary endpoint:\n\nsix-minute walk distance in meters at week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. moderate-to-severe COPD patients\n2. aged 40-80 years,\n3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,\n4. no acute exacerbation of COPD,\n5. clinically being stable for one month and longer,\n6. not undergoing exercise training program.\n\nExclusion Criteria:\n\n1. uncontrolled diabetes mellitus by plasma fasting sugar \\>200 mg/dl,\n2. uremia or CKD stage 5,\n3. chronic heart failureby NYFC III,\n4. cerebrovascular disease,\n5. uncontrolled anemia by Hb \\< 10 mg/dl,\n6. active malignant diseases,\n7. other hospitalized acute illness,\n8. systemic prednisolone \\> 10 mg per day.'}, 'identificationModule': {'nctId': 'NCT02242461', 'acronym': 'COPD', 'briefTitle': 'Rhodiola Crenulata as an Adjunctive Therapy in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CS11144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Rhodiola placebo capsules', 'description': 'starch', 'interventionNames': ['Drug: Rhodiola placebo capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Rhodiola Crenulata', 'description': 'Rhodiola Crenulata', 'interventionNames': ['Drug: Rhodiola Crenulata']}], 'interventions': [{'name': 'Rhodiola placebo capsules', 'type': 'DRUG', 'description': 'Corn starch', 'armGroupLabels': ['Rhodiola placebo capsules']}, {'name': 'Rhodiola Crenulata', 'type': 'DRUG', 'otherNames': ['Rhodiola'], 'description': 'Rhodiola Crenulata', 'armGroupLabels': ['Rhodiola Crenulata']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dawan', 'state': 'Ming-Lung Chuang', 'country': 'Taiwan', 'facility': 'Department of Critical Care Medicine and Division of Pulmonary Medicine', 'geoPoint': {'lat': 23.20917, 'lon': 120.18722}}], 'overallOfficials': [{'name': 'Ming Lung Chuang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Critical Care Medicine and Division of Pulmonary Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine', 'investigatorFullName': 'GCRC', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}