Mucosal ErosionSIMETHICONENCT05951712
Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy
A study testing Simethicone 150mg, N Acetyl cysteine 600mg and Simethicone 150mg plus N Acetyl cysteine 600 mg in people with Mucosal Erosion, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD). The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Erosion
- What is being tested?
- Simethicone 150mg, N Acetyl cysteine 600mg and Simethicone 150mg plus N Acetyl cysteine 600 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteIndia
- Study dates
- 16 Jun 2022to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (≥18-years) capable of giving written, informed consent will be included.
- All eligible subjects undergoing diagnostic endoscopy will be recruited in the study.
Who cannot join
- History of upperGI tract surgery,
- Gastric cancer
- Need for therapeutic endoscopy and emergency procedures,
- Recent upper GI bleeding
- Caustic ingestion,
- Pregnancy
Show all 9Show fewer
- Diabetes mellitus
- Asthma
- Allergic reactions to the medications used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy: A Double Blind, Randomized Controlled Trial.
In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).
The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and individual pre-medication groups (Simethicone and NAC) in patients undergoing EGD. Secondary outcomes included comparison of TMVS between different groups, TMVS in early (10-20 min) versus late (>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility was defined as a cumulative score of <7 and ≥7, respectively.
Read the detailed description
AIM: In this study, we aimed to evaluate the impact of premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).
This is a single-centre, double blinded (patients and endoscopist), randomized trial at a tertiary care academic hospital and approved by institutional review board committee (AIG/IEC-BFI and R 29 /06.2022-04).
The eligibility criteria for enrollment into the study include adult patients (>18 y) undergoing esophagogastroduodenoscopy (EGD). Exclusion criteria for the study are history of upper gastrointestinal surgery, neurological disorder with impaired swallowing, active gastrointestinal bleeding, caustic ingestion, pregnancy, known history of multiple allergies, gastric outlet obstruction, esophageal motility disorders, and contraindication for EGD.
Randomization Patients will be randomly assigned to one of four categories. The randomization algorithm is generated using Random Allocation Software v2.0. Before EGD, a clinical research coordinator will deliver the sealed randomization envelopes to a trained nurse who will administer the solution to the patients after obtaining written informed consent from the study participants. In this trial, both patients and endoscopists will be unaware of the allocation.
Interventions Patients will be randomized to the following 4 groups: group A [100 mL of water (W)]; group B [150 mg simethicone (S)]; group C [600 mg NAC (NAC)]; and group D [150 mg simethicone +600 mg NAC (SPN)]. Patients, nursing staff assisting the procedure, the endoscopist performing the procedure, and the research coordinator collecting the data will be blinded. Identical bottles will be used in all the groups for the purpose of blinding.
A trained nurse not participating in the study will administer the solution 10-30 minutes before EGD. All patients will receive pharyngeal anesthesia with 4 squirts of 10% lidocaine (Xylocaine spray 10%; Neon, Thane, India) before EGD.
After EGD, all patients will be observed for two hours for any immediate adverse events. As feasible, delayed adverse events will be evaluated within 24 hours via telephone inquiry or in-person visits.
Mucosal visibility scoring A pre-defined scoring system will be used for grading mucosal visibility in four regions in stomach (fundus, proximal body, distal body and antrum) and two regions in duodenum [first (D1 and second (D2)]. The mucosal visibility scores range from 1 to 4 (1, no adherent mucus; 2, mild mucus, but not obscuring vision; 3, large amount of mucus obscuring vision, with less than 50 ml water required to clear it; 4, heavy adherent mucus, requiring more than 50 ml water to clear). Total mucosal visibility scores (TMVS) will be estimated by adding individual mucosal visibility scores in six different regions in stomach and duodenum. The TMVS ranges from 6 (best) to 24 (worst) points.
Outcome measures The primary outcome of the study is comparison of TMVS between combined pre-medication (SPN) and individual pre-medication groups (S and NAC) in patients undergoing EGD. Secondary outcomes include comparison of TMVS between different groups (A vs B vs C vs D), TMVS in early (10-20 min) versus late (>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility is defined as a cumulative score of <7 and ≥7, respectively.
Sample size calculation In this study we aim to assess the impact of pre-medication on mucosal visibility (MVS) during EGD. We postulated that adequate MV will be at least 15% better in the combined pre-medication (WPSN) arm versus simethicone (WPS) arm.4 The sample size calculated was 346 (173 per group) to demonstrate the superiority of pre-medication with type 1 error as 0.05 and 80% power. Since, the study had four arms the estimated sample size was 692. Considering a 15% drop out rate during the follow-up, the number of cases to be enrolled was calculated to be 796 (199 in each group).
- Conditions
- Mucosal Erosion
- Being tested
- Simethicone 150mg, N Acetyl cysteine 600mg, Simethicone 150mg plus N Acetyl cysteine 600 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone 150mgDrug
Also called S
Impact of simethicone on the mucosal visibility of stomach and duodenum
N Acetyl cysteine 600mgDrug
Also called NAC
Impact of N Acetyl cysteine on the mucosal visibility of stomach and duodenum
Simethicone 150mg plus N Acetyl cysteine 600 mgDrug
Also called SPN
Impact of simethicone plus N Acetyl cysteine on the mucosal visibility of stomach and duodenum
PlaceboOther
Also called W
Impact of water on the mucosal visibility of stomach and duodenum
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Placebo comparator | In this arm, the participants will receive placebo ( 100 ml water) 10-30 minutes before the procedure under the supervision of a trained nurse. All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting.
During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points: (1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. Receives: Other: Placebo |
| Simethicone 150 mg | Experimental | In this arm, the participants will receive 150 mg simethicone dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting.
During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. Receives: Drug: Simethicone 150mg |
| N Acetyl cysteine 600 mg | Experimental | In this arm the participants will receive 600 mg N-acetyl cysteine dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting.
During endoscopy, mucosal visibility will be evaluated in 6 segments(gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. Receives: Drug: N Acetyl cysteine 600mg |
| Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination | Experimental | In this arm, the participants will receive 150 mg simethicone and N-acetyl cysteine dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting.
During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. Receives: Drug: Simethicone 150mg plus N Acetyl cysteine 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution
To achieve adequate mucosal visibility score visibilty score 0 means no mucus in duodenum, stomach
Measured: 20 minutes
Secondary outcomes (1)
Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution
To achieve adequate mucosal visibility score visibilty score 0 means no mucus in duodenum, stomach
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start16 Jun 2022
- Primary completion20 Aug 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucosal ErosionStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Zaheer Dr Nabi, MD, Principal investigator, ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951712
- Sponsor's protocol ID
- MESE01
- Acronym
- SIMETHICONE
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nabi Z, Vamsi M, Goud R, Sayyed M, Basha J, Reddy PM, Reddy R, Reddy P, Manchu C, Darisetty S, Gupta R, Tandan M, Rao GV, Reddy DN. Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial. Indian J Gastroenterol. 2024 Oct;43(5):986-994. doi: 10.1007/s12664-023-01459-0. Epub 2023 Oct 18.
PubMed 37848768
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy: A Double Blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05951712
- Acronym / sponsor ID
- SIMETHICONE / MESE01
- Conditions
- Mucosal Erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 19 Jul 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.
In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).
The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and individual pre-medication groups (Simethicone and NAC) in patients undergoing EGD. Secondary outcomes included comparison of TMVS between different groups, TMVS in early (10-20 min) versus late (>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility was defined as a cumulative score of <7 and ≥7, respectively.
Detailed description
AIM: In this study, we aimed to evaluate the impact of premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).
This is a single-centre, double blinded (patients and endoscopist), randomized trial at a tertiary care academic hospital and approved by institutional review board committee (AIG/IEC-BFI and R 29 /06.2022-04).
The eligibility criteria for enrollment into the study include adult patients (>18 y) undergoing esophagogastroduodenoscopy (EGD). Exclusion criteria for the study are history of upper gastrointestinal surgery, neurological disorder with impaired swallowing, active gastrointestinal bleeding, caustic ingestion, pregnancy, known history of multiple allergies, gastric outlet obstruction, esophageal motility disorders, and contraindication for EGD.
Randomization Patients will be randomly assigned to one of four categories. The randomization algorithm is generated using Random Allocation Software v2.0. Before EGD, a clinical research coordinator will deliver the sealed randomization envelopes to a trained nurse who will administer the solution to the patients after obtaining written informed consent from the study participants. In this trial, both patients and endoscopists will be unaware of the allocation.
Interventions Patients will be randomized to the following 4 groups: group A [100 mL of water (W)]; group B [150 mg simethicone (S)]; group C [600 mg NAC (NAC)]; and group D [150 mg simethicone +600 mg NAC (SPN)]. Patients, nursing staff assisting the procedure, the endoscopist performing the procedure, and the research coordinator collecting the data will be blinded. Identical bottles will be used in all the groups for the purpose of blinding.
A trained nurse not participating in the study will administer the solution 10-30 minutes before EGD. All patients will receive pharyngeal anesthesia with 4 squirts of 10% lidocaine (Xylocaine spray 10%; Neon, Thane, India) before EGD.
After EGD, all patients will be observed for two hours for any immediate adverse events. As feasible, delayed adverse events will be evaluated within 24 hours via telephone inquiry or in-person visits.
Mucosal visibility scoring A pre-defined scoring system will be used for grading mucosal visibility in four regions in stomach (fundus, proximal body, distal body and antrum) and two regions in duodenum [first (D1 and second (D2)]. The mucosal visibility scores range from 1 to 4 (1, no adherent mucus; 2, mild mucus, but not obscuring vision; 3, large amount of mucus obscuring vision, with less than 50 ml water required to clear it; 4, heavy adherent mucus, requiring more than 50 ml water to clear). Total mucosal visibility scores (TMVS) will be estimated by adding individual mucosal visibility scores in six different regions in stomach and duodenum. The TMVS ranges from 6 (best) to 24 (worst) points.
Outcome measures The primary outcome of the study is comparison of TMVS between combined pre-medication (SPN) and individual pre-medication groups (S and NAC) in patients undergoing EGD. Secondary outcomes include comparison of TMVS between different groups (A vs B vs C vs D), TMVS in early (10-20 min) versus late (>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility is defined as a cumulative score of <7 and ≥7, respectively.
Sample size calculation In this study we aim to assess the impact of pre-medication on mucosal visibility (MVS) during EGD. We postulated that adequate MV will be at least 15% better in the combined pre-medication (WPSN) arm versus simethicone (WPS) arm.4 The sample size calculated was 346 (173 per group) to demonstrate the superiority of pre-medication with type 1 error as 0.05 and 80% power. Since, the study had four arms the estimated sample size was 692. Considering a 15% drop out rate during the follow-up, the number of cases to be enrolled was calculated to be 796 (199 in each group).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Intervention | Placebo comparator | Other: PlaceboIn this arm, the participants will receive placebo ( 100 ml water) 10-30 minutes before the procedure under the supervision of a trained nurse. All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points: (1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. |
| Simethicone 150 mg | Experimental | Drug: Simethicone 150mgIn this arm, the participants will receive 150 mg simethicone dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. |
| N Acetyl cysteine 600 mg | Experimental | Drug: N Acetyl cysteine 600mgIn this arm the participants will receive 600 mg N-acetyl cysteine dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments(gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. |
| Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination | Experimental | Drug: Simethicone 150mg plus N Acetyl cysteine 600 mgIn this arm, the participants will receive 150 mg simethicone and N-acetyl cysteine dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with <50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (≥18-years) capable of giving written, informed consent will be included.
- All eligible subjects undergoing diagnostic endoscopy will be recruited in the study.
Key exclusion criteria (9 listed)
- History of upperGI tract surgery,
- Gastric cancer
- Need for therapeutic endoscopy and emergency procedures,
- Recent upper GI bleeding
- Caustic ingestion,
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 |
|---|---|---|
| Simethicone 150mgAlso: SImpact of simethicone on the mucosal visibility of stomach and duodenum | Drug | Simethicone 150 mg |
| N Acetyl cysteine 600mgAlso: NACImpact of N Acetyl cysteine on the mucosal visibility of stomach and duodenum | Drug | N Acetyl cysteine 600 mg |
| Simethicone 150mg plus N Acetyl cysteine 600 mgAlso: SPNImpact of simethicone plus N Acetyl cysteine on the mucosal visibility of stomach and duodenum | Drug | Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination |
| PlaceboAlso: WImpact of water on the mucosal visibility of stomach and duodenum | Other | No Intervention |
Primary outcome
Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution
Time frame: 20 minutes
To achieve adequate mucosal visibility score visibilty score 0 means no mucus in duodenum, stomach
1 secondary outcome
Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 37848768Nabi Z, Vamsi M, Goud R, Sayyed M, Basha J, Reddy PM, Reddy R, Reddy P, Manchu C, Darisetty S, Gupta R, Tandan M, Rao GV, Reddy DN. Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial. Indian J Gastroenterol. 2024 Oct;43(5):986-994. doi: 10.1007/s12664-023-01459-0. Epub 2023 Oct 18.
- 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.
Zaheer Dr Nabi, MD principal investigator
ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simethicone 150mg, N Acetyl cysteine 600mg and Simethicone 150mg plus N Acetyl cysteine 600 mg in people with Mucosal Erosion, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jul 2023. 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 India. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution (time frame: 20 minutes). 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 NCT05951712, which also lists 1 linked publication.
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 24 Jul 2023.