An open clinical study to evaluate the clinical efficacy of Siddha Sasthric Formulation Pancha Deepakini Chooranam for the treatment of Aama Kalichal

STUDYENROLLMENT

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

 â€¢        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 forenrolling in the study based on inclusion and exclusion criteria.

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

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

•        All these patients will be given unique registration card inwhich patient’s registration number of the study address, phone number andDoctor’s phone number etc. will be given, So as to report easily if anycomplications arise.

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

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

 CONDUCTOF THE STUDY:

                  Thetrial drug “Panchadeepakini Chooranam†will be given for 7 days (twice aday), Op patients should visit the hospital once in 2 days. At each clinicalvisit clinical assessment is done and prognosis should be noted. For IPpatients the drug will be given for 3 days and followed up till 7 days and theclinical assessment will be done daily. Laboratory investigations will be done0 day, 03rd day, 07th day of the trial. For IP patients who are not in asituation to stay in the hospital for a long time they will be advised toattend the OPD for further follow up.

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

    DATAMANAGEMENT:

 Afterenrolling the patient in the study, a separate file for each patient will beopened and all forms will be kept in the file. Study number, patient numberwill be entered on the top of file for easy identification. Whenever studypatient visits OPD during the study period, the respective patient’s file willbe taken and necessary recording will be made at the assessment form or othersuitable form. The screening forms will be filled separately. The Data entrieswill be monitored for completion and adverse event by HOD andpharmaco-vigilance committee. All forms will be further scrutinized in presenceof investigations by HOD for logical errors and incompleteness of data to anybias. No modification in the results is permitted for unbiased reports.