Effect of saffron supplementation on Parkinson’s disease: a study protocol for a triple-blind randomised controlled clinical trial

Assessed by RV001 · Medical statistician

Assessed on 31 Oct 2025

OverallReviewer's overall integrity assessment, derived from all research questions Some concerns

DOI 10.1136/bmjopen-2024-093167 (opens in new tab)

Resource ripekg:research-integrity-assessment/RIPEACF96EE4CD6A96F4B

5 Research Questions · 3 Evidence Items

Q1.1 — Does the study have an associated retraction?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Q1.3 — Do other studies by the research team highlight causes for concern?

Automated Assessment:Assessment produced by the automated systemYes

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsYes

Rationale: No rationale provided

Supporting Evidence (1)

Retraction NoticeSource: Retraction Watch database

Clinical trial of the effects of coenzyme Q10 supplementation on glycemic control and markers of lipid profiles in diabetic hemodialysis patients

10.1007/s11255-018-1973-z

Journal: International Urology and NephrologyPublisher: SpringerDate: 30 Apr 2020

RetractionWatch ID:Record identifier in the Retraction Watch database 28473

Rationale: Concerns/Issues About Data;Investigation by Company/Institution

About Authors: Gholamreza Askari, Alireza Soleimani, Awat Feizi

Retracts: 10.1007/s11255-018-1973-z

Q2.2 — Are there concerns relating to the timing or absence of study registration?

Automated Assessment:Assessment produced by the automated systemNo

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Supporting Evidence (2)

Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)

Registration ID: IRCT20121216011763N61

Registry: IRCT

Registry Link: https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20121216011763N61 (opens in new tab)

Registration Date: 5 Mar 2024

Prospective:Whether the trial was registered before participant recruitment began Yes

Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates Registration date is on or before LLM recruitment start date.

Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text

Recruitment Start: 21-06-2024

Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Planned study dates: 'the expected recruitment start date was 21 June 2024'.

Recruitment End: N/A

Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date No recruitment_finish date found.

Study End: 21-04-2025

Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date Planned study dates: 'the expected end date was 21 April 2025'.

Overall — What is the overall integrity assessment of the study?

Automated Assessment:Assessment produced by the automated systemN/A

Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsSome concerns

Rationale: One of four authors has concerns relating to another paper which was retracted in 2020.