Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT06739720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular 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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned in a 1:1 ratio to either the intervention group or the waitlist group. The intervention group receives CP003 capsules (5 capsules once daily) for 6 weeks. The waitlist group undergoes a 6-week waiting period without any treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in serum markers', 'timeFrame': 'From baseline to 6 weeks', 'description': 'for inflammation, immunity and oxidative aging'}], 'primaryOutcomes': [{'measure': 'Mean difference in Chalder Fatigue Score', 'timeFrame': 'From baseline to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean difference in Chalder Fatigue Score', 'timeFrame': 'From baseline to 12 weeks'}, {'measure': 'Mean difference in 36-Item Short-Form Health Survey', 'timeFrame': 'from baseline to 6 week and 12 week'}, {'measure': 'Mean difference in Fatigue Severity Score', 'timeFrame': 'from baseline to 6 week and 12 week'}, {'measure': 'mean difference in (PROMIS) Short Form Fatigue 7A survey', 'timeFrame': 'from baseline to 6 week and 12 week'}, {'measure': 'Mean difference in hospital anxiety and depression scale', 'timeFrame': 'from baseline to 6 week and 12 week'}, {'measure': 'Mean difference in Pittsburgh sleep quality index', 'timeFrame': 'from baseline to 6 week and 12 week visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Fatigue Syndrome (CFS)', 'Post-COVID ME/CFS']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to test if a Lingzhi supplement (CP003) helps people with chronic fatigue or post-COVID fatigue feel better. It will also check if the supplement is safe to use. The main questions it aims to answer are:\n\nDoes the Lingzhi supplement reduce fatigue symptoms? Is it safe to take? How does it affect the body's immune system and inflammation?\n\nResearchers will compare people taking the Lingzhi supplement to those who don't take anything (waitlist group) to see if it works.\n\nParticipants will:\n\n* Take 5 capsules once daily for 6 weeks (or wait to start treatment if in waitlist group)\n* Visit the clinic 2 times for blood tests (before and after taking the supplement)\n* Complete questionnaires 3 times about their fatigue and quality of life (4 times questionnaires for waitlist group)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the Fukuda diagnostic definition of CFS/ME or have persisting fatigue after the infection of SARS-CoV-2\n* Are able to complete a 6-week course of intervention;\n* Able to complete the online validated fatigue surveys.\n\nExclusion Criteria:\n\n* Have participated in any type of complements or herbal medicine within the past six months;\n* Have serious medical conditions that might limit their participation in this intervention;\n* Diagnosed with acute inflammation;\n* Are pregnant or are planning a pregnancy in the next 3 months.'}, 'identificationModule': {'nctId': 'NCT06739720', 'briefTitle': 'RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue', 'orgStudyIdInfo': {'id': 'HKWC-2024-320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.', 'interventionNames': ['Drug: LingZhi capsule']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist group', 'description': 'Participants initially wait for 6 weeks after randomization without intervention. After the waiting period, they receive the same CP003 supplement regimen (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.'}], 'interventions': [{'name': 'LingZhi capsule', 'type': 'DRUG', 'description': 'Lingzhi-containg capsules (CP003) is a Chinese Medicine nutritional supplement manufactured by Chinese Pharm CO LTD containing: wild red ganoderma extract, ganoderma spore powder (99.9% broken wall), β-nicotinamide mononucleotide (NMN), wild yellow ganoderma extract, wild green ganoderma extract, wild purple ganoderma extract, wild white ganoderma extract, wild black sesame extract', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'TUNG LEONG FONG', 'role': 'CONTACT', 'email': 'tlfong@hku.hk', 'phone': '+852 5660 4020'}], 'facility': 'Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'TUNG LEONG FONG', 'role': 'CONTACT', 'email': 'tlfong@hku.hk', 'phone': '+852 5660 4020'}, {'name': 'Guang Chen', 'role': 'CONTACT', 'email': 'gchen91@hku.hk', 'phone': '+852 3917 6515'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovation and Technology Commission, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}