CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 18:44:50 GMT)

CTRI Number CTRI/2010/091/000189 [Registered on: 09/06/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study SAFETY AND EFFICACY OF TOPICALLY APPLIED MOIST EXPOSED BURN OINTMENT (MEBO) COMPARED TO SILVER SULPHADIAZINE (SSD) PHASE-III CLINICAL STUDY PROTOCOL Scientific Title of A phase III, Randomized, Open label, Controlled, Multicentre, Clinical study of the Safety and Study Efficacy of Toppically Applied Moist Exposed Burn Ointment (MEBO) Compared to Silver Sulphadiazine (SSD) in subjects with Mild thermal burn injuries. Secondary IDs if Any Secondary ID Identifier HRL-CT-001/09 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr. A. Sivakumar Trial Coordinator (multi-center study) Designation Affiliation Address Abhijay Hospitals (p) LTD No. 22/2, E.S.I Hospital Road, Peravallur Chennai TAMIL NADU 600011 India Phone 044-25585322 Fax 044-42789880 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr. A. Sivakumar Query) Designation Affiliation Address Abhijay Hospitals (p) LTD No. 22/2, E.S.I Hospital Road, Peravallur Chennai TAMIL NADU 600011 India Phone 044-25585322 Fax 044-42789880 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr. A. Sivakumar Designation Affiliation Address Abhijay Hospitals (p) LTD No. 22/2, E.S.I Hospital Road, Peravallur Chennai TAMIL NADU 600011 India Phone 044-25585322

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Fax 044-42789880 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Shantou MEBO Pharmaceutical Co, Ltd., Primary Sponsor Primary Sponsor Details Name Shantou MEBO Pharmaceutical Co, Ltd., Address Type of Sponsor Details of Secondary Name Address Sponsor NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr.A. Sivakumar Abhijay Hospital (P) Ltd No:22/2 E.S.I Hospital 044-25585322 Road,Peravallur-60000 044-42789880 11 [email protected] Chennai n TAMIL NADU Dr. J Kannan B.G Hospital 1/143 B VeeraPandiyan 04639-245316 Pattinam,Thiruchandur- 04639-245708 628216 [email protected] Not Applicable N/A Dr. Gunasekaran Deepan Nursing Home 50 Bishop 0431-2792449 Road,Puthur-620017 0431-0421449 Not Applicable [email protected] N/A Dr.Poongodi Omsakthi Hospital No: 4 04342-260388 Ranganathan Sengodipuram,-636701 04342-263188 Dharmapuri omsakthihospital@gmai TAMIL NADU l.com Dr. G.Balakrishna Right Hospitals Professor 044-26403939 Research Institute for Subramaniam General Plastic Hand Street,Kilpauk-600010 [email protected] Trauma, Centre of Chennai o.in Excellence For TAMIL NADU Microsurgery Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Madras Ethical Approved No Date Specified Not Available Committee Regulatory Clearance Status Date Status from DCGI Approved/Obtained No Date Specified Health Condition / Health Type Condition Problems Studied Mild thermal burn injuries Intervention / Type Name Details Comparator Agent Intervention MEBO (Moist Expose Burn Made up of 5 components Ointment) (Radix Scutellariae 4.50%, Rhizoma Coptidis 4.50%, Cortex Phellodendri 4.50%,

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Pheritima 1.80%, Pericarpium Papaveris 1.80%, Oleum Sesami 82.90%). Dosage once A Day application for 14 Days Comparator Agent Silver Sulphadiazine (SSD) Dosage is once A Day application for 14 Days Inclusion Criteria Inclusion Criteria Age From Age To Gender Details 1. Mild thermal origin burns (Superficial II Degree burns and total burn area for all burns on a single patient no greater than 15% of TBSA); 2. Male or female between 13 and 50 years of age; 3. Patient or patient?s legally acceptable representative is willing to provide voluntary informed consent; 4. Capable of understanding and willing to comply with study protocol requirements; 5. Agree to stay in hospital for the first 7 days of treatment; 6. Female of childbearing potential with a negative result from pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial; and 7. Subjects infected with MRSA can be included based on the opinion of the Investigator. Exclusion Criteria Exclusion Criteria Details 1. Subjects with chemical, electrical, and radiation burns; 2. Pregnant or breast-feeding female; 3. Known or suspected allergies to any of the components of MEBO; 4. Subjects who in the opinion of the Investigator are not suitable for inclusion; 5. Subjects previously on any other topical treatment except SSD; 6. Any immune deficiency disorder, or known clinically significant organ or systemic diseases, such that, in the opinion of the investigator, the significance of the disease will compromise the subject?s participation in the study (e.g., severe retinopathy requiring laser therapy, terminal kidney disease etc.); or 7. Participation in another investigational drug study within 30 days prior to treatment start. Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To evaluate the safety of MEBO in comparison 14 Days with SSD in the patients with mild thermal burn injuries, through the clinical laboratory report, physical examination, the invasive infection rate. Secondary Outcome Outcome Timepoints To evaluate the efficacy of MEBO in comparision 10 Days with SSD in the patients with mild thermal burn injuries, through the assessment of analgesic effect, the wound healing time (days), the wound healing rate in 10 days and the wound healing quality Target Sample Size Total Sample Size=200 Sample Size from India= 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

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Date of First No Date Specified Enrollment (India) Date of First 05/05/2010 Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Open to Recruitment Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary The investigational drug (MEBO) is a botanical ointment for treating burn injuries and cutaneous wounds. It is manufactured from seven traditional Chinese medicinal materials including Radix Scutellariae Baicalensis, Rhizoma Coptidis, Cortex Phellodendri Amurensis, Pheretima, Pericarpium Papaveris, Oleum Sesami, and Cera Flava. All of these raw materials are described in the Chinese Pharmacopoeia, and have a long history of human use with supporting modern pharmacological and toxicological research data. MEBO has been used as the standard of treatment for burns in China since its marketing approval in 1988. Through 2009, it has been marketed in twenty-four countries with more than 4 million patient uses. The once daily applications of MEBO or SSD will be continued in 200 subjects throughout the 2-Week Treatment Period or until the study wound is completely closed as defined in the protocol, whichever occurs first. If a study wound is completely closed prior to 14 days, the subject will be required to complete the End of Treatment visit assessments and the 2-Week post treatment visits. No applications should be missed and no other products should be used with or instead of MEBO or SSD (except in cases of severe infection and withdrawal from the study).

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