Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT05772104
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 495}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the HAM-A Total Score at Week 12', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8', 'timeFrame': 'Change from Baseline to Week 2, 4, and 8', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.'}, {'measure': 'The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.'}, {'measure': 'The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.'}, {'measure': 'Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': 'HAM-A Mental Anxiety Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28.'}, {'measure': 'Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': 'The HAM-A Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28.'}, {'measure': 'Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': 'The scale evaluates the quality of life in four areas: physiology, psychology, social relations and environment.'}, {'measure': 'Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': "The CGI-S is measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. This measure uses a 0-7 scale, with higher scores indicating greater anxiety severity."}, {'measure': 'Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': "CGI-I measured the clinician's perception of the participant's improvement at the time of assessment compared with the baseline. Scores could have ranged from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12', 'timeFrame': 'Change from Baseline to Week 2, 4, 8 and 12', 'description': 'TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.', 'detailedDescription': 'This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).\n\nIn stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.\n\nIn stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；\n2. Age 18-65 years old；\n3. Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；\n4. Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline\n5. The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.\n\nExclusion Criteria:\n\n1. Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；\n2. Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening\n3. Hamilton Depression Rating Scale (HAMD-17) Total Score of \\> 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；\n4. Patients with Severe Insomnia.'}, 'identificationModule': {'nctId': 'NCT05772104', 'briefTitle': 'Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'KH109-CS01-CRP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Shugan Jieyu Capsules', 'description': 'Participants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.', 'interventionNames': ['Drug: Shugan Jieyu Capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Experimental: Shugan Jieyu Capsules Placepo', 'description': 'Participants received Shugan Jieyu Capsules Placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.', 'interventionNames': ['Drug: Shugan Jieyu Capsules Placebo']}], 'interventions': [{'name': 'Shugan Jieyu Capsules', 'type': 'DRUG', 'description': 'Oral, 4 Capsules, BID', 'armGroupLabels': ['Experimental: Shugan Jieyu Capsules']}, {'name': 'Shugan Jieyu Capsules Placebo', 'type': 'DRUG', 'description': 'Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID\n\nDrug: Placebo, Oral, 1 capsule, BID', 'armGroupLabels': ['Experimental: Shugan Jieyu Capsules Placepo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Wang', 'role': 'CONTACT', 'email': 'adgangwang@163.com', 'phone': '+8613911695727'}], 'facility': 'Beijing Anding Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ling Song', 'role': 'CONTACT', 'email': '022516@cnkh.com', 'phone': '028-81258178'}], 'overallOfficials': [{'name': 'Gang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anding Hospital Affiliated to Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Jishengtang Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}