Esophageal VaricesNCT05979935
A Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Cirrhosis
An observational study of Esophageal Varices and Liver Cirrhosis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The aim of this observational study is to establish an AI deep learning model that can dianosie high-risk varices for patients with cirrhosis effeciently. The main question of this study is to esplore: question 1: Developing a digital tongue diagnosis model, specifically a deep learning model to diagnose high-risk… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Varices, Liver Cirrhosis, Sublingual Varices
- What is being tested?
- tongue diagnosis
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects in this study are patients with liver cirrhosis from the Department of Gastroenterology, Qilu Hospital, Shandong University and other 15 hospitaals. According to the 《Prevention and Treatment Plan for Viral Hepatitis》 revised by the Infectious Diseases and Parasitic disease Branch and Hepatology Branch of the Chinese Medical Association in September 2000, Patients with liver cirrhosis and esophageal varices aged 18-75 years will be included in the study.
Who may be able to join
- Age 18-75 years (including both age limits), no gender restrictions;
- Diagnosed with cirrhosis based on clinical presentation, laboratory tests, imaging studies, and/or histopathological examination;
- Undergone upper gastrointestinal endoscopy within the past 3 months prior to enrollment and have complete endoscopic imaging records;
- Undergone enhanced CT or MRI scan of the upper abdomen within the past month prior to enrollment;
- Patients who consent to enrollment and have signed an informed consent form.
Who cannot join
- Patients who have previously undergone endoscopic treatment for esophageal or gastric varices, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, hepatectomy, balloon occlusion of the portal vein, or liver transplantation;
- Patients with grade 2-3 ascites or overt hepatic encephalopathy;
- Patients with a history of portal venous system thrombosis (including the portal vein, splenic vein, superior mesenteric vein, etc.) or portal venous cavernous transformation, and who have been diagnosed with thrombosis within the past two weeks;
- Patients diagnosed with or suspected of having primary liver cancer or other advanced malignant tumors;
- Patients with chronic obstructive pulmonary disease and right heart failure;
- Male and female patients with moderate anemia (hemoglobin <70 g/L);
Show all 17Show fewer
- Patients with poorly controlled diabetes or microvascular complications;
- Patients with poorly controlled hypertension;
- Patients with hematological disorders such as polycythemia vera;
- Patients with local oral lesions affecting sublingual venous blood flow, such as Ludwig's angina, Lemierre syndrome, or complications following certain oral surgeries (e.g., scar contracture or hematoma after tongue or floor of mouth surgery);
- Patients with sublingual venous varicosities;
- Patients who have experienced other severe systemic infections within the past 2 weeks prior to enrollment;
- Pregnant women and peripartum women;
- Patients with mental disorders;
- Patients with incomplete medical records;
- Patients unable to cooperate in completing the clinical study;
- Other reasons deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study on the Diagnostic Value of Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Patients With Liver Cirrhosis
The aim of this observational study is to establish an AI deep learning model that can dianosie high-risk varices for patients with cirrhosis effeciently.
The main question of this study is to esplore:
Read more
question 1: Developing a digital tongue diagnosis model, specifically a deep learning model to diagnose high-risk esophageal and gastric varices (HRV) associated with cirrhosis using sublingual vein images. Answering the question of whether the new tongue diagnosis method can accurately diagnose.
Question 2: Compare the diagnostic efficacy digital tongue diagnosis model with diagnostic models constructed using other biochemical indicators for HRV in cirrhosis, and answer the question of "how to use it optimally."
Question 3: Exploring the correlation between sublingual vein characteristics and Hepatic venous pressure gradient (HVPG).
Question 4: Compared with endoscopic examination results, validate the diagnostic performance of the model (AUC ≥ 0.90) and screen for key parameters of sublingual vein characteristics (such as sublingual vein varicosity diameter, vein length, color, etc.).
Question 5: Follow-up tongue examination images of patients with cirrhosis who underwent treatment (e.g., endoscopy, splenic embolization, TIPS, etc.) at 1, 2, and 3 years post-treatment were evaluated to assess the efficacy of digital tongue examination models in predicting high-risk esophageal and gastric variceal bleeding at 1, 2, and 3 years post-treatment, as well as the efficacy in predicting endoscopic treatment failure rates and patient mortality associated with bleeding.
Read the detailed description
Firstly, participants will be divided into two groups according to their degree of esophageal varices from endoscopic examination and CT report, including high-risk varices (HRV) group and low-risk varices (LRV) group. Secondly, participants will be asked to show their tongue, including the surface and sublingual veins of tongue, and the tongue images of each participants will be collected by researchers via camera. After finishing tongue image collection, participants will receive a professional tongue diagnosis report in Traditional Chinese Medicine and health suggestion. Finally, tongue images will be analyzed by AI deep learning model and some specifialized information will be estracted exactly. Besides, 60 patietns will be selected to eplore whtether sublingual vein characteristics is assoicated with HVPG. Finally, patietns will be followed up during 3 years, and gastric variceal bleeding, endoscopic treatment failure rates, and patient mortality risks related to bleeding will be analyzed.
- Being tested
- tongue diagnosis
- Keywords
- Esophagogastroduodenal Varices, Liver cirrhosis, Sublingual vein, Portal hypertension
- Medical subject headings
- Esophageal and Gastric Varices, Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tongue diagnosisDiagnostic test
The tongue image of participants will be collected via camera, and tongue images will be used for AI deep model learning analysis.
| Study group | Role | What they receive |
|---|---|---|
| patients with high-risk of esophageal varices in liver cirrhosis | The maximum diameter of varices ≥ 5 mm or maximum diameter of varices <5mm with positive red sign in patients with liver cirrhosis Receives: Diagnostic Test: tongue diagnosis | |
| patients with low-risk of esophageal varices in liver cirrhosis | the maximum diameter of esophageal varices < 5 mm without positive red sign in patients with liver cirrhosis. Receives: Diagnostic Test: tongue diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of tongue diagnostic model
Using endoscopic diagnostic criteria as the "gold standard," we calculated the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value of the VIT-based digital tongue diagnosis model to evaluate its diagnostic performance in diagnosing HRV in cirrhosis.
Measured: through study completion, up to 3 years
Secondary outcomes (4)
ROC of biochemical characteristic
Calculate the AUC valthe digital tongue diagnosis model.ue, sensitivity, specificity, positive predictive value, negative predictive value, and other relevant parameters of the ROC curve for the HRV diagnostic model for cirrhosis constructed based on biochemical indicators, and compare them with
Measured: through study completion, up to 3 years
Association between HVPG and sublingual vein
The association between sublingual vein and HVPG
Measured: through study completion, up to 3 years
Characteristic of sublingual vein
Key parameters for screening sublingual vein characteristics (such as sublingual vein varicosity diameter, vein length, color, etc.).
Measured: through studyy completion, up to 3 years
The rate of esophageal variceal bleeding, endoscopic treatment failure, and patient mortality
The incidence of esophageal variceal bleeding, endoscopic treatment failure rate, and patient mortality related to bleeding in patients with cirrhosis 1, 2, and 3 years after diagnosis.
Measured: through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Jul 2023
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Shanghai East Hospital of Tongji University, Eighth Affiliated Hospital, Sun Yat-sen University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Tianjin Medical University General Hospital, Army Medical Center of PLA, Shandong Provincial Hospital, Qianfoshan Hospital, Shandong Public Health Clinical Center, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Jinan Central Hospital, Weifang People's Hospital, Liaocheng People's Hospital, The Second Affiliated Hospital of Shandong First Medical University, Jining First People's Hospital
- Responsible party
- Principal investigator, Yanjing Gao, Qilu Hospital of Shandong University
- Investigators
- Yanjing Gao, PhD MD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979935
- Sponsor's protocol ID
- 20230726-QiluH
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ou J, Li R, Zeng R, Wu CQ, Chen Y, Chen TW, Zhang XM, Wu L, Jiang Y, Yang JQ, Cao JM, Tang S, Tang MJ, Hu J. CT radiomic features for predicting resectability of oesophageal squamous cell carcinoma as given by feature analysis: a case control study. Cancer Imaging. 2019 Oct 16;19(1):66. doi: 10.1186/s40644-019-0254-0.
PubMed 31619297Tandon M, Singh H, Singla N, Jain P, Pandey CK. Tongue thickness in health vs cirrhosis of the liver: Prospective observational study. World J Gastrointest Pharmacol Ther. 2020 Aug 8;11(3):59-68. doi: 10.4292/wjgpt.v11.i3.59.
PubMed 32844044He C, Liao Q, Fu P, Li J, Zhao X, Zhang Q, Gui Q. Microbiological characteristics of different tongue coatings in adults. BMC Microbiol. 2022 Sep 9;22(1):214. doi: 10.1186/s12866-022-02626-7.
PubMed 36085010Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.
PubMed 34115257Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29.
PubMed 36174643de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Diagnostic Value of Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05979935
- Acronym / sponsor ID
- 20230726-QiluH
- Keywords
- Esophagogastroduodenal Varices, Liver cirrhosis, Sublingual vein, Portal hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Shanghai East Hospital of Tongji University, Eighth Affiliated Hospital, Sun Yat-sen University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Tianjin Medical University General Hospital, Army Medical Center of PLA, Shandong Provincial Hospital, Qianfoshan Hospital, Shandong Public Health Clinical Center, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Jinan Central Hospital, Weifang People's Hospital, Liaocheng People's Hospital, The Second Affiliated Hospital of Shandong First Medical University, Jining First People's Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to establish an AI deep learning model that can dianosie high-risk varices for patients with cirrhosis effeciently.
The main question of this study is to esplore:
question 1: Developing a digital tongue diagnosis model, specifically a deep learning model to diagnose high-risk esophageal and gastric varices (HRV) associated with cirrhosis using sublingual vein images. Answering the question of whether the new tongue diagnosis method can accurately diagnose.
Question 2: Compare the diagnostic efficacy digital tongue diagnosis model with diagnostic models constructed using other biochemical indicators for HRV in cirrhosis, and answer the question of "how to use it optimally."
Question 3: Exploring the correlation between sublingual vein characteristics and Hepatic venous pressure gradient (HVPG).
Question 4: Compared with endoscopic examination results, validate the diagnostic performance of the model (AUC ≥ 0.90) and screen for key parameters of sublingual vein characteristics (such as sublingual vein varicosity diameter, vein length, color, etc.).
Question 5: Follow-up tongue examination images of patients with cirrhosis who underwent treatment (e.g., endoscopy, splenic embolization, TIPS, etc.) at 1, 2, and 3 years post-treatment were evaluated to assess the efficacy of digital tongue examination models in predicting high-risk esophageal and gastric variceal bleeding at 1, 2, and 3 years post-treatment, as well as the efficacy in predicting endoscopic treatment failure rates and patient mortality associated with bleeding.
Detailed description
Firstly, participants will be divided into two groups according to their degree of esophageal varices from endoscopic examination and CT report, including high-risk varices (HRV) group and low-risk varices (LRV) group. Secondly, participants will be asked to show their tongue, including the surface and sublingual veins of tongue, and the tongue images of each participants will be collected by researchers via camera. After finishing tongue image collection, participants will receive a professional tongue diagnosis report in Traditional Chinese Medicine and health suggestion. Finally, tongue images will be analyzed by AI deep learning model and some specifialized information will be estracted exactly. Besides, 60 patietns will be selected to eplore whtether sublingual vein characteristics is assoicated with HVPG. Finally, patietns will be followed up during 3 years, and gastric variceal bleeding, endoscopic treatment failure rates, and patient mortality risks related to bleeding will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with high-risk of esophageal varices in liver cirrhosis | – | Diagnostic Test: tongue diagnosisThe maximum diameter of varices ≥ 5 mm or maximum diameter of varices <5mm with positive red sign in patients with liver cirrhosis |
| patients with low-risk of esophageal varices in liver cirrhosis | – | Diagnostic Test: tongue diagnosisthe maximum diameter of esophageal varices < 5 mm without positive red sign in patients with liver cirrhosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects in this study are patients with liver cirrhosis from the Department of Gastroenterology, Qilu Hospital, Shandong University and other 15 hospitaals. According to the 《Prevention and Treatment Plan for Viral Hepatitis》 revised by the Infectious Diseases and Parasitic disease Branch and Hepatology Branch of the Chinese Medical Association in September 2000, Patients with liver cirrhosis and esophageal varices aged 18-75 years will be included in the study.
Key inclusion criteria (5 listed)
- Age 18-75 years (including both age limits), no gender restrictions;
- Diagnosed with cirrhosis based on clinical presentation, laboratory tests, imaging studies, and/or histopathological examination;
- Undergone upper gastrointestinal endoscopy within the past 3 months prior to enrollment and have complete endoscopic imaging records;
- Undergone enhanced CT or MRI scan of the upper abdomen within the past month prior to enrollment;
- Patients who consent to enrollment and have signed an informed consent form.
Key exclusion criteria (17 listed)
- Patients who have previously undergone endoscopic treatment for esophageal or gastric varices, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, hepatectomy, balloon occlusion of the portal vein, or liver transplantation;
- Patients with grade 2-3 ascites or overt hepatic encephalopathy;
- Patients with a history of portal venous system thrombosis (including the portal vein, splenic vein, superior mesenteric vein, etc.) or portal venous cavernous transformation, and who have been diagnosed with thrombosis within the past two weeks;
- Patients diagnosed with or suspected of having primary liver cancer or other advanced malignant tumors;
- Patients with chronic obstructive pulmonary disease and right heart failure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tongue diagnosisThe tongue image of participants will be collected via camera, and tongue images will be used for AI deep model learning analysis. | Diagnostic test | patients with high-risk of esophageal varices in liver cirrhosis, patients with low-risk of esophageal varices in liver cirrhosis |
Primary outcome
AUC of tongue diagnostic model
Time frame: through study completion, up to 3 years
Using endoscopic diagnostic criteria as the "gold standard," we calculated the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value of the VIT-based digital tongue diagnosis model to evaluate its diagnostic performance in diagnosing HRV in cirrhosis.
4 secondary outcomes
ROC of biochemical characteristic
Time frame: through study completion, up to 3 years
Association between HVPG and sublingual vein
Time frame: through study completion, up to 3 years
Characteristic of sublingual vein
Time frame: through studyy completion, up to 3 years
The rate of esophageal variceal bleeding, endoscopic treatment failure, and patient mortality
Time frame: through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Results publication: PubMed 31619297Ou J, Li R, Zeng R, Wu CQ, Chen Y, Chen TW, Zhang XM, Wu L, Jiang Y, Yang JQ, Cao JM, Tang S, Tang MJ, Hu J. CT radiomic features for predicting resectability of oesophageal squamous cell carcinoma as given by feature analysis: a case control study. Cancer Imaging. 2019 Oct 16;19(1):66. doi: 10.1186/s40644-019-0254-0.
- Results publication: PubMed 32844044Tandon M, Singh H, Singla N, Jain P, Pandey CK. Tongue thickness in health vs cirrhosis of the liver: Prospective observational study. World J Gastrointest Pharmacol Ther. 2020 Aug 8;11(3):59-68. doi: 10.4292/wjgpt.v11.i3.59.
- Results publication: PubMed 36085010He C, Liao Q, Fu P, Li J, Zhao X, Zhang Q, Gui Q. Microbiological characteristics of different tongue coatings in adults. BMC Microbiol. 2022 Sep 9;22(1):214. doi: 10.1186/s12866-022-02626-7.
- Results publication: PubMed 34115257Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.
- Results publication: PubMed 36174643Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29.
- Results publication: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanjing Gao, PhD MD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices and Liver Cirrhosis, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of tongue diagnostic model (time frame: through study completion, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05979935, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.