Oushadhi Panchakarma Hospital and Research Institute

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OushadhiPanchakarma Hospital and ResearchInstitute, THRlssuR-680022(A Government of Keraraundertaking) Phone: 0487-2334996,299451 g, Fax: O4gZ- 2gg4g96, Email:oushadhipanchakarma @gmait.com [email protected]. Lett'erReference Number:cLrN-ousHDHr-'l dated 06 May 20i3 Date:25 May 2013 To, Dr.SheelaKaralam.B Spl.Officer(R&D) Oushadhi Kuttane ll ur,Thrissur-{4 Kerala India subject: Ethicscommiftee approvarfor the conduct of the referencedstudy. Reference:Study Gode: GLIN€USHADHI-OI study Title: "A singtecentre pilot open tabet ctinicattriat toassess the safetyand efficacy of pnmehoushadhitabletas a monotherapy and an adiuantin patiintswith rype 2 DiabetesMettitus,, DearDr. Sheela, We har,ereceir,led fom you the followingdocuments: Your letter dated 06 May 2013with regardsto the proposal of carryingout the referencedstudy at ousHADHlpanchakarma Hospitarand Research institute,Thrissur Version Numberand Version Date Version01 dated22 Apnl2013 SubjectInformed Consent form in Version01 dated22 Apnl2013 Translationof the SubjectInfonned ConsentForm in Malayalam Version01 dated22 Apnl2013 Version01 dated22 April2013 At the Institutional Ethics committee, panchakarma ousHADH| Hospital and Research institute'Thrissurmeeting held on 11-08-2012 panchakarma at OUSHADHI Hospitaland Research institute'Thrissur,the aborementioned documentswere examined, revewed and discussed. Themembers who attended the meetingat whichyour studyproposar was discussedare as follows: OushadhiPanchakarma H osprtal and ResearchInstitute, THRISSUR-680022(AGovernment of Keralaundertaking) Phone: 0487-2354996,2gg451 g, Fax: A4gT- 2994996, Email:oushadhipanchakarma @gmail.com [email protected]. Affiliation [Designation/TiUe Sr. no. Name of the member Role in the EG Qualification Name and Adc (City, State) Affiliated Instituk PRINCIPAL,VISHN 1. Dr.K.MuralidharanPillai Chairperson MD (Ayurveda) AYT]RVEDA COLI,ECi[iSHORAT\ Managing 2. Sri.R.RShukla,IFS Secretary TFS Director,Oushadhi Asst.Prof Basic Medical Crovt.Medical 3. MBBS,MD Dr.P.S.Vasudevan Scientist College, Thrissur 4. Dr.K.V.Ramankutty Warier Clinician DAM Retd.DMO(ISM) Medical 5 Dr.RoyJoseph Clinician MD(AY) OfficerflSM) District 5. Adv.K.V.Subrahmanian Legal expert LLB Court Thrissur KeralaVeterinary 6. Dr.Sunanda.C Statistitian Ph.D University,Mannu thv Social worker/Lay OiscaIntemational 7. Smt.VinniJaeadish GRADUATE person ThrissurChaoter We appror,e the trialto be conductedin its presentedform. The appiolat is rafiafor Z Vears. We herebyconlirm that neitheryou nor any of yourstudy team members have participated in the roting/ decisionmaking procedure of the committee.The membersof the committeewho hale participatedin the wting/ decisionmaking procedure of the committeedo not hare any conflictof interestin the referencedstudy. TheInstitutional Ethics Committee, oUSHADHI Panchakarma Hospital and Researchinstitute,Thrissur expectsto be informedabout: 1. Theprogress of the studyhalf yearly. 2. Any SAEoccuning in the courseof the study. 3. Any changesin the protocoland patientinformation/informed consent. Alsoyou arerequested to providea copyofthe finalreport. This Ethics Committeeis organizedand operatesaccording to GoodClinical practice and Scheduley requirements. Yoursr\ sincerelv. \\ IJ+/^^?W-- i-i 1 MemberSecretary, Ethics Committee. .

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