PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 10:57:04 GMT)

CTRI Number CTRI/2020/04/024799 [Registered on: 22/04/2020] - Trial Registered Prospectively Last Modified On 06/04/2021 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Homeopathy Study Design Single Arm Trial Public Title of Study Homoeopathy for Diarrhoea in children Scientific Title of UTILITY OF COMPLETE REPERTORY IN THE MANAGEMENT OF ACUTE DIARRHOEA IN Study CHILDREN OF AGE GROUP 5-13 YEARS Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Shrikant S Patil Trial Coordinator (multi-center study) Designation PG STUDENT Affiliation Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR Address Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR 416101 Phone 8956689586 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ravindra Bhanadare Query) Designation Guide Affiliation Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR Address Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR Kolhapur MAHARASHTRA 416101 India Phone 9850897898 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ravindra Bhanadare Designation Guide Affiliation Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR Address Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR

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MAHARASHTRA 416101 India Phone 9850897898 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dr Shrikant Patil Dr. J.J. Magdum homoeopathic medial collage and hospital opd no 3, block 1 , floor 1st, jayisngpur Primary Sponsor Primary Sponsor Details Name Dr Shrikant Patil Address 441/3 A Trimurti Colony ,100 feet road, near khandej ration shop, Type of Sponsor Other [self] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Shrikant Patil Dr J J MAGDUM Dr J J MAGDUM 8956689586 HOMEOPATHIC HOMOEOPATHIC MEDICAL COLLEGE MEDICAL COLLEGE patil.shrikant620@gmail HOSPITAL JAYSINGPUR OPD no .com JAYSINGPUR 3 room 3 block 1 jaysingpur Kolhapur MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Dr J J MAGDUM Approved 28/03/2018 No HOMEOPATHIC MEDICAL COLLEGE HOSPITAL IEC Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Disease of digestive system, unspecified Intervention / Type Name Details Comparator Agent Intervention Homoeopathic Medicine 200c, stat dose or repetition on basis of homeopathic principles and administered orally Comparator Agent homoeopathic medicine or 200c, stat dose or repetition on placebo basis of homeopathic principles and administered orally Inclusion Criteria Inclusion Criteria Age From 5.00 Year(s) Age To 13.00 Year(s) Gender Male Details a. Patient age group of 5 to 13 years will be selected.
b. Both

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sexes will be selected. c. Reporting cases of symptoms of acute diarrhoea. d. Diagnosis is mainly based on clinical presentation, case history of patient. Exclusion Criteria Exclusion Criteria Details a. Acute Diarrhoea receiving antibiotics b. Patient with advanced pathology and chronic diarrhoea.Cases with immune-compressed state. c. Acute diarrhea with complication and diagnosed with systemic illness.

Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints To study the scope of homoeopathy in acute 24-48 HRS diarrhoea when medicine is given using Complete Repertory Secondary Outcome Outcome Timepoints To study the scope of homoeopathy in acute 18 months diarrhoea from Complete Repertory Target Sample Size Total Sample Size=30 Sample Size from India=30 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 3/ Phase 4 Date of First 01/05/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Nil Brief Summary Role of homoeoapthic treatment in acute case will be reviewed with this research and will be helpful for paediatric treatments so i like explore

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