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NCT04022941
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
NA trial testing Sodium Benzoate in Chronic Liver Disease in 108 participants. Completed in 31 December 2018.
31 December 2018
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 1 April 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across India |
Drugs / interventions tested
- Sodium Benzoate (SODIUM BENZOATE) — full drug profile →
- Powdered table sugar as palcebo
Conditions studied
- Chronic Liver Disease — all drugs for Chronic Liver Disease →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 1 Day to 18, any sex, with Chronic Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg stat and 750mg /kg in next 24 hours,keeping in view that 2/3 of powder used would be powdered sugar in the intervention arm. The dose of the powder used would be doubled in case of the ammonia level more than 300 mcg/dl. The drug will be prepared in sterile water and administered per orally or via the nasogastric tube. All the enrolled patients would be treated with SMT as per the recommendations of the EASL/AASLD 2014 guidelines of management of hepatic encephalopathy. Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04022941
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Related trials
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Trials testing the same drug.
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Currently open trials in the same condition.
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Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04022941 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 17 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04022941.
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