Combination of oral and intravenous drugs for treatment of kala-azar in India
- Conditions
- Health Condition 1: null- Treament of Visceral Leishmaniasis
- Registration Number
- CTRI/2016/08/007190
- Lead Sponsor
- Dr Rama Prosad Goswami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
Patients with corroborative clinical history (prolonged fever not responding to antimalarials or antibiotics) and physical signs (anaemia, splenomegaly, hepatomegaly) with presence of parasites (LD bodies) confirmed by examination of Giemsa stained slides of splenic or bone marrow aspirates were enrolled into the study.
Confirmed visceral leishmaniasis patients who are fully informed about the risk of treatment and who signed the consent form themselves or by authorised relatives in their languages , will be included in the study group
HIV positive individuals, Infant and children with body weight < 10Kgs, severe concurrent illnesses, receipt of any antileishmanial drugs or antifungal drugs in the previous 45 days, pregnancy and withdrawal of contraceptive measure. Patients with known hypersensitivity to the study drugs and those with diabetes, hypertension, or tuberculosis were also excluded. All patients with known heart, liver or kidney disease were excluded from the study. patients with renal function tests (serum creatinine) outside the normal range, liver function tests (transaminases) more than three times upper limit of the normal at study entry, Jaundice (bilirubin > 2.0mg/dL), Known hepatitis B or C positive, Platelet count less than 40,000/mm3, Prothrombin time 5 seconds or greater than normal range, Total WBC < 1,000/mm3, known alcohol or other drug abuse,concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc, concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days were excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical : fever , Spleen size, Anaemia, appetite, Body weight <br/ ><br>2. Parasitological : Spleen/ Bone marrow smearTimepoint: 1. Clinical : end of treatment, at 6 months of follow - up and 2 - 4 years of follow up <br/ ><br>2. Parasitological: End of treatment, at 6 months
- Secondary Outcome Measures
Name Time Method Drug related adverse effects (Common Terminology Criteria for Adverse Events version 3.0)Timepoint: Throughout treatement duration and at six months