To know the Safe and Effect of 5-aminolevulinic acid hydrochloride and Sodium Ferrous Citrate combination drug on Malaria Patients to treat malaria.

Phase 2

Conditions: Health Condition 1: B509- Plasmodium falciparum malaria, unspecified

Registration Number: CTRI/2018/09/015824

Lead Sponsor: eopharma Japan Co Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Weighing 40 to 90 kg

2. Women with child bearing potential willing to give consent for pregnancy test.

3.Patients and spouse/partner who is of childbearing potential must be using 2 acceptable methods of contraception one of which must be a physical barrier method, (eg. Spermicidal gel plus condom; condom plus partner is sterilized at least 6 months prior) for the entire study duration.

4. Presence of symptomatic uncomplicated P. falciparum with a

diagnosis confirmed by:

microscopically confirmed parasite infection, between 1000 and

100,000 asexual parasite count/Î¼l of blood

fever, as defined by axillary/tympanic of >= 37.5Â°C or

oral/rectal/temperature of >= 38.0Â°C, or history of fever

within previous 24 hours (must be documented)

5. Patients must be willing and able to give written informed consent and comply with all study visits and procedures.

Exclusion Criteria

1. Patients with signs and symptoms of severe/complicated malaria

requiring parenteral treatment according to the World Health

Organization Criteria 2010

2. Severe vomiting, defined as more than three times in the 24 hours

prior to inclusion in the trial or inability to tolerate oral treatment

3. Presence of febrile conditions caused by diseases other than malaria

4. Known history of photo-hypersensitivity, porphyria, or

hemochromatosis

5. Have taken any medication with antimalarial or antibiotic with

antimalarial effect in previous 14 days

6. Received an investigational drug within the past 4 weeks

7. Patients whose Hb level is lower than 8 g/dL

8. Liver function tests [AST/ALT levels] more than 2.5 times upper

limit of normal values

9. Known significant renal impairment as indicated by serum creatinine

of >= 1.4 mg/dL or eGFR of < 45 mL/min.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Cure rate on Day 28 [Time Frame: 28 days since the start of definitive oral antimalarial therapy] defined as the proportion of patients with PCR-corrected Adequate Clinical and Parasitological Response (ACPR). <br/ ><br>2.Safety [Time Frame: 42 days since the start of definitive oral antimalarial therapy] Incidence of any adverse event. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1st Time Point: On day 28 <br/ ><br>2nd Time Point: On day 42 <br/ ><br> <br/ ><br>

Secondary Outcome Measures