Who is sponsoring NCT01260012?

NCT01260012 is sponsored by Addis Ababa University.

What drugs are being tested in NCT01260012?

Interventions in NCT01260012: Praziquantel+antioxidant suppl, Praziquantel + placebo 2mths then antioxidant for 10 mths, Praziquantel therapy and placebo as supplement, Praziquantel+antioxidant.

What condition does NCT01260012 study?

NCT01260012 studies Schistosomiasis, Liver Fibrosis, Periportal Fibrosis, Oxidative Stress.

Is NCT01260012 still recruiting?

NCT01260012 is currently status unknown. Last updated 14 December 2010.

Last reviewed 2010-12-14 · How we verify

NCT01260012

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study on the Role of Antioxidant Micronutrients on the Reversal of Schistosomal Peri-portal Fibrosis of the Liver.

Status unknown NA Last updated 14 December 2010

What this trial tests

NA trial testing Praziquantel+antioxidant suppl in Schistosomiasis in 414 participants. Status unknown.

Timeline

1 January 2010

Primary endpoint
1 June 2013

1 December 2015

Quick facts

Lead sponsor	Addis Ababa University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	414
Start date	1 January 2010
Primary completion	1 June 2013
Estimated completion	1 December 2015
Sites	1 location across Ethiopia

Drugs / interventions tested

Praziquantel+antioxidant suppl
Praziquantel + placebo 2mths then antioxidant for 10 mths
Praziquantel therapy and placebo as supplement
Praziquantel+antioxidant

Conditions studied

Schistosomiasis — all drugs for Schistosomiasis →
Liver Fibrosis — all drugs for Liver Fibrosis →
Periportal Fibrosis — all drugs for Periportal Fibrosis →
Oxidative Stress — all drugs for Oxidative Stress →

Sponsor

Addis Ababa University

Who can join

Adults 5 to 60, any sex, with Schistosomiasis or Liver Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Effect of antioxidant supplement on fibrosis reversal following praziquantel therapy
Time frame: 2 years
Patients schistosomal periportal fibrosis will be treated with praziquantel at the start, at six weeks and at 3 months from the start of the study. Praziquantel therapy will then be offered if subjects have demonstrable S. mansoni eggs on six-monthly evaluation periods. In addition, one group will recieve supplemental antioxidant for one year, the second group will recieve supplement as a placebo

Sponsor's own description

Liver fibrosis is the most serious complication of schistosomiasis mansoni. However only limited proportion of subjects with infection develop this pathology and there is limited knowledge on risk factors for the differential morbidity patterns observed in endemic communities. Our preliminary cross-sectional study indicated that serum levels of antioxidants may be related with the development of fibrosis. The present project is a randomised double blinded placebo controlled prospective study investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Addressing the heterogeneity in liver diseases using biological networks.
Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002

Verify or expand the search:

Other recruiting trials for Schistosomiasis

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT06560853 — Evaluation of a Comprehensive School Health Programme in Zambia · NA · active not recruiting

Other Addis Ababa University trials

Trials by the same sponsor.

NCT07499375 — Effect of a Peer Support Intervention on Glycemic Control and Economic Burden Among Patients With Diabetes · NA · completed
NCT07145983 — Effect of Peer Support Intervention on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes · NA · completed
NCT06515301 — Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia · NA · recruiting
NCT07382089 — Effect of Oral Hygiene Care on Prevention of Aspiration Pneumonia Among Hospitalized Stroke Patients · NA · completed
NCT05515913 — Nutritional Status and ASD Severity of Autistic Spectrum Disorder Children in Addis Ababa, Ethiopia; Case Control Study · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01260012 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Addis Ababa University
Last refreshed: 14 December 2010

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/NCT01260012.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing