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A clinical trial to study effect of changing Albendazole dose and frequency of administration on W.bancrofti(a filarial worm)microfilaria clearance

Effect of Albendazole dose and interval on Wuchereria bancrofti microfilarial clearance in India: a randomized, open level study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004113
Enrollment
100
Registered
2013-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Wuchereia bancrofti infected person

Interventions

Intervention1: Albendazole and DEC: Arm 2 400 mg of Albendazole and 300mg of DEC Biannually orally single dose Arm 3 800 mg of Albendazole and 300mg of DEC Annually orally single dose Arm 4 800 mg o

Sponsors

Regional Medical Research Centre Chandrasekharpur Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Treatment - Age 18 years to 55 years - Men and non-pregnant or non-breastfeeding women - Microfilarial levels >50 mf /ml - Willingness to spend 3 days in hospital - Willingness to undergo night time blood draws every 6 months for 2 years - Ability to understand and sign the informed consent - Hb levels for inclusion >9 g/dl - Normal Cr, ALT

Exclusion criteria

Exclusion criteria: Treatment â?? Non-volunteers â?? Age 55 years â?? Pregnancy or breast-feeding â?? Hgb â?? Cr > 1.2/100 ml â?? ALT > 30 U â?? Alcohol consumption of more than 2 beers or other alcohol-containing drink/day within a week of each drug administration â?? Serious medical illness â?? History of benzimidazole allergy â?? History of DEC allergy â?? Use of Albendazole or DEC within past 6 months â?? Unwillingness to comply with required study visits

Design outcomes

Primary

MeasureTime frame
To determine whether increasing the Albendazole dose or the frequency of treatment with DEC /Albendazole is more effective than the current WHO-approved mass treatment regimen at clearing microfilariamia as assessed by night time microfilarial counts.Timepoint: Baseline,6,12,18and 24 months.

Secondary

MeasureTime frame
To assess the effect of these treatments on adult worm burden in those subjects with detectable worm nests at baseline by ultrasound of adult worm nests at 12 and 24 months and the circulating antigen assay.Timepoint: Baseline,12 and 24 months

Countries

India

Contacts

Public ContactDr B Dwibedi

Regional Medical Research Centre

bhagirathidwibedi@yahoo.com06742300134

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026