KAMRC Research

 
 
 


 Sl.No.
 
 
 
 
 
Name of Trial/Non Trial


 
 
 
 
Start Year
 
 
 
 
 
End Year
 
 
 
 
 
No. of Participant's
 
 
 
 
 
Total No of patient
 
 
 
 
 
Sponsor
 
 
 
 
 
Title
 
 
 
 
 
Drug
 
 
     1
 
 
 
 
     Study # 3154   
 
 
 
 
     1999
 
 
 
 
     2000
 
 
 
 
       1 to 145
 
 
 
 
           145
 
 
 
 
     Asta Medica
 
 
 
 
To assess efficacy and safety of orally administered miltefosine in patients with visceral leishmaniasis with Control group: Amphotericin B
 
 
 
 
      Miltefosine
 
 
 
 
     2
 
 
 
 
     Study # 3152 
 
 
 
 
     1999
 
 
 
 
     1999
 
 
 
 
       1 TO 20
 
 
 
 
           20
 
 
 
 
     Asta Medica
 
 
 
 
To assess efficacy and safety of orally administered miltefosine in children with visceral leishmaniasis
 
 
 
 
      Miltefosine
 
 
 
 
     3
 
 
 
 
     Milt
 
 
 
 
     2001
 
 
 
 
     2001
 
 
 
 
       1 to 18
 
 
 
 
           18
 
 
 
 
     Asta Medica
 
 
 
 
A multicenter phase II trial of miltefosine in Indian Visceral Leishmaniasis
 
 
 
 
      Miltefosine
 
 
 
 
     4
 
 
     252220B(WR602)
 
 
     2002
 
 
 
 
     2002
 
 
 
 
       1 TO  45
 
 
 
 
           45
 
 
 
 
     GSK      
 
 
 
 
Determination of oral Sitamaquine for efficacy, safety and tolerance in subjects with visceral leishmaniasis caused by L. donovani in India sponsored by GSK, India
 
 
 
 
      Sitamaquin
 
 
 
 
     5
 
 
 
 
     MILT PHASE IV TRIAL
 
 
 
 
     2003
 
 
 
 
     2003
 
 
 
 
       1 TO 367
 
 
 
 
           367
 
 
 
 
 ICMR
 
 
 
 
ICMR-Phase IV Trial of Miltefosine in the Treatment of Visceral Leishmaniasis
 
 
 
 
      Miltefosine
 
 
 
 
     6
 
 
     VLPM01
 
 
     2003
 
 
 
 
     2003
 
 
 
 
       1 TO 250
 
 
 
 
           250
 
 
 
 
     iOWH 
 
 
 
 
Multicentre, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients with Visceral Leishmaniasis
 
 
 
 
             Paromomycin/               Amphotericin B
 
 
 
 
     7
 
 
 
 
     ABE Phase II Trial
 
 
 
 
     2004
 
 
 
 
     2004
 
 
 
 
       1 TO 45
 
 
 
 
           45
 
 
 
 
 
 
 
 
 
Short  course amphotericin B and Fat emulsion in the treatment of Indian kala-azar
 
 
 
 
              AmphotericinB       Emalsion
 
 
 
 
     8
 
 
 
 
     STQ 105938
 
 
 
 
     2006
 
 
 
 
     2007
 
 
 
 
       1 TO 38
 
 
 
 
           19
 
 
 
 
     GSK
 
 
 
 
A Phase II, multi centre, randomised study to evaluate the safety, tolerability and pharmcokinetics of oral sitamaquine compared with Amphotericin B in the treatment of Visceral Leishniasis caused by L.donovani in endemic areas.
 
 
 
 
            Sitamaquine 
 
 
 
 
     9
 
 
 
 
     SRA
 
 
 
 
     2007
 
 
 
 
     2007
 
 
 
 
       1 TO  60
 
 
 
 
           60
 
 
 
 
     SIRO
 
 
 
 
A prospective, single centre, open level, Dose escalation Phase II study to access and efficacy of short course regimens of Amphomul ( Amphotericin B Emulsion). In Treatment Naïve or Resistant cases of Visceral Leishmaniasis(Kala-Azar)
 
 
 
 
         Amphomul
 
 
 
 
     10
 
 
 
 
     VLPM03
 
 
 
 
     2007
 
 
 
 
     2007
 
 
 
 
       1 TO 67
 
 
 
 
           67
 
 
 
 
     iOWH
 
 
 
 
A phase three multicentre randomized control clinical trial to assess the safety and efficacy of injectable parmomycine in patients with visceral leishmaniasis sponsored by Institute of One world Health and WHO
 
 
 
 
         PAROMOYCIN
 
 
 
 
     11
 
 
 
 
     COMBO