Combined Phase 1 and Phase 2 protocol
Clinical research
From published human evidence to a registered Phase 1/2 study.
Clinical research is shown as a traceable evidence pathway: the prior peer-reviewed human study, the current registry record, the study design and HETCHYN’s documented manufacturing role.
- Published human study
- Phase 1 / Phase 2
- Registered protocol
Adults with retinitis pigmentosa
Two treatment periods and washout
Goldschleger Eye Institute, Sheba
Evidence pathway
Two stages, with different evidence status.
The 2013 paper reports completed human research. NCT07509229 is an active Phase 1/2 study progressing according to its registered protocol. The two records represent different stages of the evidence pathway.
Published · 2013
Randomized crossover trial in retinitis pigmentosa
The peer-reviewed JAMA Ophthalmology paper evaluated a 9-cis beta-carotene-rich Dunaliella powder and reported visual-function outcomes in adults with retinitis pigmentosa.
Read the publicationRegistered Phase 1 / Phase 2
NCT07509229 at Sheba Medical Center
A randomized, masked, crossover study compares active Dunaliella softgels with a matched corn-oil placebo. ClinicalTrials.gov lists the study as enrolling by invitation and progressing under its registered protocol.
View the live registry recordRegistry evidence
The manufacturing relationship is stated in the public record.
The intervention description names Hetchyn Ingredients Biotechnology Co., Ltd. as manufacturer of the active Dunaliella softgel capsules. The sponsor and study conduct remain with Sheba Medical Center.
Verify on ClinicalTrials.govClinicalTrials.govNCT07509229
SponsorSheba Medical Center
PhasePhase 1 · Phase 2
Study typeRandomized crossover
Current registry statusEnrolling by invitation
Last update posted27 July 2026
Manufacturer named in intervention recordHetchyn Ingredients Biotechnology Co., Ltd.
Active softgel: oil extraction of Dunaliella, approximately 70% 9-cis and 30% all-trans beta-carotene isomers.
Study design
What the registered protocol is designed to measure.
The design uses active and placebo periods separated by a washout, with assessments at baseline and the end of each phase.
Active period
Two active softgel capsules twice daily for 90 days; each capsule contains Dunaliella oil rich in beta-carotene.
Matched placebo
Corn-oil softgels are made to match the active capsules in size, colour and texture to maintain masking.
Six-month washout
The protocol uses an extended washout between treatment periods to reduce carry-over from circulating beta-carotene.
Measured outcomes
The primary outcome is retinal sensitivity by microperimetry, supported by retinal, visual, blood and safety measures.
Study progress
The registered Phase 1/2 study is progressing according to protocol.
NCT07509229 is moving forward through its registered study pathway. This page documents the public protocol and HETCHYN’s stated manufacturing role while the clinical work continues under the sponsor’s direction.
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