Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-29 @ 7:54 AM
Study NCT ID:
NCT06900569
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ashwagandha Supplementation for Prevention of Muscle Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C030693', 'term': 'Ashwagandha'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-03-15', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in isometric biceps strength measured with a dynamometer (Nm)', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Change in muscle thickness measured with ultrasound (cm)', 'timeFrame': '72 hours'}, {'measure': 'Change in muscle soreness measured with a visual analog scale with scores ranging from 0 (no soreness) to 10 (maximal soreness)', 'timeFrame': '72 hours'}, {'measure': 'Change in sleep quality with the Pittsburgh Sleep Quality Index with scores ranging from 0 (no sleep problems) to 3 (lowest sleep quality)', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Damage']}, 'descriptionModule': {'briefSummary': 'Ashwagandha is an herbal supplement that has a wide range of benefits related to exercise when supplemented for about 8-12 weeks. This study aims to investigate whether short-term Ashwagandha supplementation can enhance muscle recovery following exercise by measuring muscle strength recovery, swelling, and soreness in the biceps.', 'detailedDescription': 'The purpose of the study is to determine the effects of Ashwagandha supplementation on recovery from muscle-damaging exercise. Ten to twenty participants will be randomized to receive Ashwagandha supplementation (600 mg/d) or placebo for 10 days. On day 7, participants will perform a muscle damaging exercise session (six sets of concentric and emphasized eccentric repetitions with the biceps). Before and after exercise and at 24, 48, and 72 hours after exercise, isometric muscle strength, muscle swelling (ultrasound), and muscle soreness will be assessed. The investigators hypothesize the Ashwagandha will alleviate symptoms of muscle damage (swelling and soreness) and enhance strength recovery after a bout of muscle-damaging exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: male or female, aged 18-35y\n\n\\-\n\nExclusion Criteria:\n\nConditions that may be affected by exercise (determined by "yes" answers to the "Get Active Questionnaire") Pregnant Breastfeeding\n\nAllergies to:\n\n* Dicalcium Phosphate\n* Cellulose\n* Vegetable magnesium stearate\n* Silica'}, 'identificationModule': {'nctId': 'NCT06900569', 'briefTitle': 'Ashwagandha Supplementation for Prevention of Muscle Damage', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Ashwagandha Supplementation for Recovery From Muscle-damaging Exercise and Sleep Quality', 'orgStudyIdInfo': {'id': '2024_25_06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '600 mg/d placebo for 10 days', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ashwagandha', 'description': '600 mg/d Ashwagandha', 'interventionNames': ['Dietary Supplement: Ashwagandha']}], 'interventions': [{'name': 'Ashwagandha', 'type': 'DIETARY_SUPPLEMENT', 'description': '600 mg/d Ashwagandha', 'armGroupLabels': ['Ashwagandha']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '600 mg/d placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7K 2X2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Philip Chilibeck', 'role': 'CONTACT', 'email': 'phil.chilibeck@usask.ca', 'phone': '3062303849'}], 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'centralContacts': [{'name': 'Philip Chilibeck', 'role': 'CONTACT', 'email': 'phil.chilibeck@usask.ca', 'phone': '3062303849'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Chilibeck', 'investigatorAffiliation': 'University of Saskatchewan'}}}}