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Randomized Phase IIb/III Clinical Trial Protocol of BALEG Syrup, a Phytomedicine Formulated from Balanites aegyptiaca Del. (Zygophyllaceae) Kernels, for the Treatment of Intestinal Parasitic Infections.

Essai clinique de phase Ib/III du BALEG Sirop, phytomédicament à base des amandes de Balanites aegyptiaca Del. (Zygophyllaceae) pour letraitement des infections parasitaires intestinales

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202510869237604
Enrollment
243
Registered
2025-10-06
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helminthosis

Interventions

Albendazole
BALEG Syrup

Sponsors

Health Sciences Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • infected with intestinal parasites ; • are between 5 and 15 years of age; • have given their consent for children aged between 12 and 15 years; • have parents or guardians who have signed the informed consent form; • be able to take the drug orally; • have visited a health facility at the study site; • reside in the geographical area of the sites for the duration of the treatment; • accept the study procedures.

Exclusion criteria

Exclusion criteria: • undergoing specific treatment for intestinal parasitosis ; • with known allergies to the study drugs or any of their components; • participating in any other ongoing clinical study; • with biochemical parameters (transaminases, creatinemia, urea) above normal; • have a chronic pathology: cancer, asthma, renal or hepatic insufficiency; • with serious neurological or mental disorders.

Design outcomes

Primary

MeasureTime frame
Parasite clearence (negative Kato-Katz stool test) in 95% of patients;Occurrence of a serious adverse event

Secondary

MeasureTime frame
1. Improvement of clinical signs of intestinal parasitic infection such as diarrhea, abdominal pain, vomiting, or fever at any time after Day 3, or worsening of clinical condition compared to baseline 2.A difference of less than 10% in the reduction of parasite eggs in patients receiving BALEG Syrup compared to those receiving Albendazole 3. Acceptability of the BALEG Syrup phytomedicine among children

Countries

Burkina Faso

Contacts

Public ContactBelemlilga Mohamed

Health Science research institute

medilga@yahoo.fr0022670240809

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026