Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT04621903
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19
Sponsor:
Organization:
Raw JSON
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Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach.\n\nCBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),\n* With mild or moderate manifestations of COVID-19\n* Willing to participate, and consent by signing the informed consent and not involved in another clinical trial during the study period\n\nExclusion Criteria:\n\n* Patients suffering from severe COVID-19 Disease as judged by WHO criteria (REF)\n* Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit\n* Patients with ongoing immunosuppressive therapy for any reasons for example solid organ transplantation, autoimmune diseases or cancer.\n* Patients with known long term infection like HIV\n* Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.\n* Pregnancy and lactation\n* Ayurveda practitioner decision that involvement in the study is not in the patient's best interest"}, 'identificationModule': {'nctId': 'NCT04621903', 'briefTitle': 'A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Aarogyam UK'}, 'officialTitle': 'A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19: Community Based Participatory Research', 'orgStudyIdInfo': {'id': 'AU/WU/ 06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ayurveda', 'interventionNames': ['Other: Shanshamani Vati Plus']}], 'interventions': [{'name': 'Shanshamani Vati Plus', 'type': 'OTHER', 'description': 'Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.', 'armGroupLabels': ['Ayurveda']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Aarogyam (UK) CIC', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Vishwesh Kulkarni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Warwick'}, {'name': 'Neha Sharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarogyam UK'}, {'name': 'Dipa Modi', 'role': 'STUDY_CHAIR', 'affiliation': 'East Park Medical Centre, Leicester NHS Trust'}, {'name': 'Tanuja Nesari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'All India Institute of Ayurveda, Ministry of AYUSH, Government of India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarogyam UK', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Warwick', 'class': 'OTHER'}, {'name': 'All India Institute of Ayurveda, Ministry of AYUSH, Government of India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}