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Study to assess efficacy of Doxycycline in Improving Filarial Lymphedema in India

Phase 3
Conditions
Health Condition 1: B741- Filariasis due to Brugia malayi
Registration Number
CTRI/2017/08/009312
Lead Sponsor
Task Force for Global Health
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
235
Inclusion Criteria

Resident in endemic area for filariasis for >5yrs

-Body weight >40Kg

-Lymphedema of a limb stage 1-6 measured on a 7 point scale

-Able to give informed consent

-Ability to use established methods of hygiene

-Normal laboratory profile

Exclusion Criteria

-No lymphedema or lymphedema stage 7

-Age < 14 years or > 65 years

-Body weight < 40 kg

-Pregnant or breastfeeding women

-Women of childbearing potential not using an agreed method of contraception. (A pregnancy test will be conducted as part of the screening process to exclude pregnancy and repeated at 3 and 8 weeks. In addition, women of childbearing potential will be counseled against pregnancy during the treatment period)

-Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease

-Alcohol or drug abuse

-History of adverse reactions to doxycycline or other tetracyclines

-Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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