Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-25 @ 4:08 PM
Study NCT ID:
NCT05219357
Status:
UNKNOWN
Last Update Posted:
2022-02-02
First Post:
2022-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008515', 'term': 'Medicine, Ayurvedic'}], 'ancestors': [{'id': 'D008519', 'term': 'Medicine, Traditional'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Death by Suicide', 'timeFrame': 'From Index ED visit to 30 days', 'description': 'Death by suicide within 30 days of the index ED visit'}], 'primaryOutcomes': [{'measure': 'Brief Symptom Inventory', 'timeFrame': 'Change from baseline to 48 hours and 7th-days of intervention', 'description': 'Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity'}, {'measure': 'Length of Emergency hospital stay', 'timeFrame': 'Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)', 'description': 'Length of stay is defined as the time between patient triage and discharge from the emergency department'}], 'secondaryOutcomes': [{'measure': 'The Kessler Psychological Distress Scale (K10)', 'timeFrame': 'Change from baseline to 3rd and 7th-days of intervention', 'description': "The K10 comprises 10 items that rate symptoms along the anxiety-depression spectrum, with a five point Likert response, where one is 'none of the time' to five 'all of the time."}, {'measure': 'The Psychological Outcome Profiles instrument', 'timeFrame': 'From Baseline to 3rd and 7th-days of intervention', 'description': "To measure participant-generated outcomes comprising four items on 6 scale (0-5) 0 = not at all affected' to '5 = severely affected."}, {'measure': 'Agitation Calmness Evaluation Scale (ACES)', 'timeFrame': 'From Baseline to 48 hours and 7th-days of intervention', 'description': 'The ACES consists of a single item that rates overall agitation at the time of patients observations on 9 scale (1=marked agitation, 4=normal behaviour, 9= unarousable)'}, {'measure': 'Positive and Negative Syndrome Scale;', 'timeFrame': 'From Baseline to 48 hours and 7th-days of intervention', 'description': 'The tool consists of 5 items: excitement, tension, hostility, being uncooperative, and poor impulse control. Each item is scored on 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme)'}, {'measure': 'Satisfaction with acute care', 'timeFrame': 'From Baseline to 3rd and 7th-days of intervention', 'description': 'Measured on 5-point scale, completed by the participant using the Service Satisfaction Scale 10 (SSS-10), from 1 (No, definitely not) to five (Yes, definitely)'}, {'measure': 'Side effects', 'timeFrame': 'From Index ED visit to 30 days', 'description': 'The frequency of any side effects or adverse events experienced by individuals to both intervention group on 4 point scale (landing from absent=0 to severe=3)'}, {'measure': 'Medication use', 'timeFrame': 'From Index ED visit to 30 days', 'description': 'Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ayurveda', 'Mental Health', 'Emergencies', 'Community Based Participatory Research'], 'conditions': ['Psychiatric Disorder']}, 'descriptionModule': {'briefSummary': "For patients undergoing a psychiatric crisis, hospitalisation is required. In developing countries specially in sub-urban or rural areas, most patients don't access intensive care. In India, AYUSH system of medical care is widely used, including crisis resolution and community treatment have been widely implemented in various mental health systems. However, evidence to support their effectiveness has remained very low.\n\nPresent study is designed as community based participatory research, where Ayurveda treatment , a short-term, specialised, crisis intervention is provided by community outreach team."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presenting with a psychiatric complaint.\n* Male or female patients at least 18 years of age.\n* Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.\n\nExclusion Criteria:\n\n* Patients who have delirium or dementia\n* Prisoners\n* Pediatric patients\n* Elderly patients\n* Pregnancy or breastfeeding"}, 'identificationModule': {'nctId': 'NCT05219357', 'briefTitle': 'Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations', 'organization': {'class': 'OTHER', 'fullName': 'Aarogyam UK'}, 'officialTitle': 'Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis: Pilot Trial Using Community-Based Participatory Research', 'orgStudyIdInfo': {'id': 'NMP1873-92'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Group (UCG)', 'description': 'The usual care control group received care only on hospital wards during episodes', 'interventionNames': ['Drug: Usual-Care']}, {'type': 'OTHER', 'label': 'Ayu Care Group (ACG)', 'description': 'Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.', 'interventionNames': ['Other: Ayu-Care']}], 'interventions': [{'name': 'Ayu-Care', 'type': 'OTHER', 'otherNames': ['Ayurveda'], 'description': 'Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.', 'armGroupLabels': ['Ayu Care Group (ACG)']}, {'name': 'Usual-Care', 'type': 'DRUG', 'description': 'Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.', 'armGroupLabels': ['Usual Care Group (UCG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Gyansanjeevani', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'NMP Medical Research Institite', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Neha Sharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarogyam (UK) CIC'}, {'name': 'Venkata N Joshi', 'role': 'STUDY_CHAIR', 'affiliation': 'Croydon Ayurveda Centre'}, {'name': 'Maël Voegeli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AVP Research Foundation'}, {'name': 'Skanthesh Lakshmanan', 'role': 'STUDY_CHAIR', 'affiliation': 'NMP Medical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participants Data will not be available to other researchers. Data will only be shared through publications and presentations on study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarogyam UK', 'class': 'OTHER'}, 'collaborators': [{'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, {'name': 'Croydon Ayurveda Centre', 'class': 'UNKNOWN'}, {'name': 'Active Naturals Limited', 'class': 'UNKNOWN'}, {'name': 'AVP Research Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}