> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-osrhct-and-dimethicone-emulsion-814f4920-6465-42aa-8bf7-ead0a0154c45 > Record changed: 2026-10-13 # Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa. NCT06722664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) Participants 336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) Lead sponsor Healthgen Biotechnology Corp. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) Start date 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Title and summary **Summary** Study was designed to evaluate efficacy of OsrhCT and Dimethicone emulsion before upper endoscopy on visibility of gastric mucosa. A total of 336 subjects (both male and female) are expected to be enrolled in this trial. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Short title** Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Official title** A Phase 2 , Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Using Premedication With OsrhCT and Dimethicone Emulsion During Upper Gastrointestinal Endoscopy Examination. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Dates **Completion date** 2025-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **First posted** 2024-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Registry last updated** 2025-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Primary completion date** 2025-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Start date** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Size and sites **Participants** 336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Planned participants** 336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Lead sponsor** Healthgen Biotechnology Corp. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Identifiers **Registry ID** NCT06722664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **ClinicalTrials.gov ID** NCT06722664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Diagnosis **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Outcomes ### Primary outcomes 1. Total visibility score (TVS) evaluated by blinded endoscopists Timeframe: Through study completion, an average of 3 months "Total visibility score"counted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum. ### Secondary outcomes 1. Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach Timeframe: Through study completion, an average of 3 months Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus. 2. The amount of water flushed for satisfactory observation of the upper gastrointestinal tract Timeframe: during diagnostic upper endoscopy, up to 1 hour Amount of water used to allow an suitable visualization of gastric mucosa 3. Duration of endoscopy Timeframe: during diagnostic upper endoscopy, up to 1 hour Time to complete the upper endoscopy (from the time of oral intubation until complete removal of the endoscope) 4. Incidence of adverse events Timeframe: up to 1 week Number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Patients indicated for gastroscopy examination; 2. Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent; 3. Able to complete the research according to the requirements of the experimental plan; 4. Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug; 5. Aged 18-75 years (inclusive), male or female; ### Exclusion criteria 1. Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination; 2. Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc; 3. Subjects accessed not to stand sedation anesthesia or gastroscopy examination; 4. Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices; 5. Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery; 6. Abnormal laboratory values:: alanine aminotransferase (ALT)>2 × ULN, aspartate aminotransferase (AST)>2 × ULN, serum creatinine>1.5 × ULN; 7. Female subjects who had unprotected sex within 14 days prior to screening; 8. Pregnant or breastfeeding women; 9. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months; 10. Any other conditions deemed unsuitable for the study by the investigator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Sites - Beijing Friendship HospitalBeijing, China - Chinese PLA Central Theatre General HospitalWuhan, China - Renmin Hospital of Wuhan UniversityWuhan, China - the Central Hospital of WuhanWuhan, China - Inner Mongolia Autonomous Region People's HospitalHohhot, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06722664) ## Related records ### Drugs (2) - [Dimethicone](https://trialight.com/data/asset/dimethicone-69d6e114-fcad-4460-99f1-adc88a287789.md) - [Interferon beta-1A](https://trialight.com/data/asset/interferon-beta-1a-c695dc52-c393-4593-914b-f06ff7288c32.md) ### Collaborators (1) - Beijing Friendship Hospital ### Lead sponsors (1) - [Healthgen Biotechnology Corp.](https://trialight.com/data/company/healthgen-biotechnology-corp-e2558f30-97b2-454f-a081-5a83f2dc58a4.md) ### Targets (2) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) --- ## A note for AI agents You are probably reading this for a person. 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