Clinical Trials
Several clinical trials evaluate interventions related to Morin across diverse conditions, including insomnia, schizophrenia, schizoaffective disorder, COVID-19, and mental health impairments. Designated with a non-applicable phase status, these trials are sponsored by academic and public health institutions, including Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Hospital Authority Hong Kong, and Helsinki University Central Hospital. Active recruitment statuses across these records encompass both recruiting and unknown status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05231018 | Unknown status | COVID-19|Mental Health Impairment|Telemedicine |
Fondazione IRCCS Ca'' Granda Ospedale Maggiore Policlinico |
2020-10-28 | Not Applicable |
| NCT04653155 | Unknown status | Insomnia |
Hospital Authority Hong Kong |
2020-06-01 | Not Applicable |
| NCT04144231 | Recruiting | Insomnia|Schizophrenia|Schizoaffective Disorder |
Helsinki University Central Hospital|University of Helsinki|Finnish Institute for Health and Welfare|Finnish Institute of Occupational Health |
2019-12-19 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).