EPI-RU-ELDERLY — structured trial abstract
EPI-RU-ELDERLY — Epithalon in ageing: observational
§1Structured abstract
§1.1Objective
To evaluate Epithalon in biological ageing and healthspan endpoints, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Observational cohort analysis
- Masking
- Not applicable
- Phase
- Not applicable
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- Multi-year
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
All-cause mortality and functional indices in an older cohort
§1.4Principal result
The Institute has not been able to obtain a protocol, a randomisation procedure or an analysis plan for the reports circulated under this name and grades all claims in this programme very low certainty.
Reports circulated in the Russian-language literature. The Institute records the absence of retrievable methodological detail as the finding.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Not held | Not recorded by the Institute. The field is left empty rather than estimated. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |