STUDY ENROLLMENT

In this study, patients reporting at the OPD with the clinical symptoms of

•         Regurgitation of milk

•         Diarrhoea with mucus or blood

•         abdominal pain

•         nausea and vomiting

•         head ache

•         Anaemia (due to blood loss in motion)

•         Loss of appetite

•         Fever

•         Chillness of extremities

•         Low pitched voice etc.

            Patient will be examined clinically for enrolling in the study based on inclusion and exclusion criteria.

•         The patients who are to be enrolled patients would be informed (Form IV) about the study, trial drug, possible outcomes and the objectives of the study in the language and terms understandable to them and to their informants.

•         After ascertaining the parent’s willingness, informed consent would be obtained in writing from them in the consent form (Form IV-A).

•         All these patients will be given unique registration card in which patient’s registration number of the study address, phone number and Doctor’s phone number etc. will be given, So as to report easily if any complications arise.

•         Complete clinical history, complications and duration, examination findings – all would be recorded in the prescribed proforma in the history and clinical assessment forms separately. Screening form- I   will be filled up; Form I-A, Form II and Form III will be used for recording the patient’s history, clinical examination of symptoms, signs and laboratory investigations respectively.

•         Patients would be advised to take the trial drug and appropriate dietary advice (Form IV-D) would be given according to the patient’s perfect understanding.

CONDUCT OF THE STUDY:

           The trial drug “Panchadeepakini Chooranam” will be given for 7 days (twice a day), Op patients should visit the hospital once in 2 days. At each clinical visit clinical assessment is done and prognosis should be noted. For IP patients the drug will be given for 3 days and followed up till 7 days and the clinical assessment will be done daily. Laboratory investigations will be done 0 day, 03rd day, 07th day of the trial. For IP patients who are not in a situation to stay in the hospital for a long time they will be advised to attend the OPD for further follow up.

              Siddha investigations like Neerkuri and Neikuri will be carried over. After the end of the treatment the patient will be advised to visit the OPD for another 1 week for follow up. If any trial patients who fail to collect the trial drug on the prescribed day but wants to continue in the trial from the next day or two, he/she will be allowed, but defaulters of the week and more will not be allowed to continue and be withdrawn from the study with a fresh case being included.

DATA MANAGEMENT:

            After enrolling the patient in the study, a separate file for each patient will be opened and all forms will be kept in the file. Study number, patient number will be entered on the top of file for easy identification. Whenever study patient visits OPD during the study period, the respective patient’s file will be taken and necessary recording will be made at the assessment form or other suitable form. The screening forms will be filled separately. The Data entries will be monitored for completion and adverse event by HOD and pharmaco-vigilance committee. All forms will be further scrutinized in presence of investigations by HOD for logical errors and incompleteness of data to any bias. No modification in the results is permitted for unbiased reports.