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ANNEXURE INFORMED CONSENT PARTICIPANTS / PATIENT INFORMATION SHEET

Participant ID . Title: Comparative efficacy of Quinine and Artesunate in the treatment of severe malaria In children: A randomized controlled trial Principal Investigator: Dr. Mantu Chakma Name of guide: Dr. (Mrs.) Jayanti Chakrabarti Professor & H.O.D, Department of Paediatrics. Co-guide: Dr. N.R Majumder Assistant Professor, Department of Paediatrics. Co-guide: Dr.Tapan Majumder Assistant Professor, Department of Microbiology.

INTRODUCTION My name is Dr. Mantu Chakma. I am working in a study at Agartala Government Medical College & G.B.Pant Hospital, Agartala, Tripura. The subject of my study is comparative efficacy of quinine and Artesunate in the treatment of severe malaria in children CONSENT FROM PARENTS OR GUARDIANS You are being requested to allow participation of your child for this study. It is necessary for you to receive complete information about this study for the participation. Therefore you will have to read this form (or someone else may read it out to you). If you are willing to let your child participate in this study, you will sign this consent form and put the date on it. If you

2 wish to participate but are unable to sign it you may put your left thumb impression or a witness may sign in your presence. Purpose of study: To compare the efficacy of quinine and Artesunate in the treatment of severe malaria in Children. Procedure of study: The study is basically a prospective, randomized open-lebelled controlled study. Certain investigations like routine blood test, CT Scan of Brain, Lumbar Puncture etc. may have to be done if required. Expected duration of subjects participation: Clinical case history taking and physical examination may be necessary through whole hospital stay. After discharge, there will be periodical follow up according to need. Risk and benefit of participation in the study: Your child may be benefited from this study by making early diagnosis and optimal treatment for his/her disease. Also, community members may be benefited in the future from information learnt from this study. If you decide not to participate in this study, or wish to withdraw from the study at any time, you will continue to receive services from us. Confidentiality: All the information about the patients will be kept confidential. This information will not be given to anybody else without your permission. However, collective data without identifiers will be presented and may be published.

INFORMED CONSENT FORM

I______________________________________ r/o__________________________________ age ___________ give my free and voluntary consent for my baby to be included in the above mentioned clinical study. I have been explained to my full satisfaction the nature and purpose of and possible complications by doctor _________________________ . During the course of the study, I shall give my voluntary consent to undergo any blood or radiological investigation and any other relevant investigation and clinical photography required for the study. I will abide by the prescribed medication regimen and other instructions. I will present myself/patient at the designated time and place in the hospital during study follow-up. During the course of the study I will immediately inform about any adverse effect/ events related to my treatment. I will give my full cooperation to the concerned treatment doctor and the hospital staff. I give my consent for publication of the result of the study. I will not seek any reward or compensation for the study. I have been explained that I can withdraw from the study at any time to my own will without any adverse effect on my treatment. I also give my voluntary consent to be enrolled in either treatment group (quinine or Artesunate as the case may be) depending upon the randomized allocation.

Signature /Thumb impression Patients Name

Date and Time

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Patients / Guardians name ( ) -----------------------Name of witness ( --------------------)

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Dr. Mantu Chakma ----------------------

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