REF/2011/04/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Wed, 03 Jan :58:35 GMT) CTRI Number Last Modified On 06/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/05/ [Registered on: 04/05/2011] - Trial Registered Prospectively No Interventional Ayurveda Randized, Parallel Group, Placebo Controlled Trial A clinical trial to study the efficacy and safety of Viracure cream in patients with Genital Herpes virus 2 infection. A Phase II, randized, assessor-blind, placebo-controlled, multicenter, cparative, prospective study to assess the efficacy and safety of Viracure cream in immunocpetent patients with Genital Herpes due to Herpes Simplex Virus -2 infection. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Viracure/54/10 Designation Affiliation Protocol Number Details of Principal Investigator Dr Salman Bhoira Consultant dermatologist Phone Fax Designation Affiliation Dawood Nursing He, 21-Memni Building, Dimtimkar Road, Nagpada, salmanbhoira@yahoo.co.in Details Contact Person (Scientific Query) Dr Sujay Kulkarni Phone Fax Designation Affiliation Deputy general Manager - Clinical development Piramal Life sciences limited, 1, Nirlon Cplex, Off Western Express Highway,Goregaon (East) sujay.kulkarni@piramal.c Details Contact Person (Public Query) Dr Sujay Kulkarni Piramal Life sciences limited, 1, Nirlon Cplex, Off Western Express Highway,Goregaon (East) page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Piramal Life Sciences Limited, Type of Sponsor None List of Countries of Principal Investigator Dr Salman Bhoira Source of Monetary or Material Support Primary Sponsor Details Piramal Life Sciences Limited 1 Nirlon cplex, Off western express highway, Goregaon east, Pharmaceutical industry-n of Site Site Phone/Fax/ Dawood Nursing He 21-Memni Bldg., Dimtimkar Rd., Nagpada, Dr Sudhir Medhekar Dr. Joshis Clinic 212, Kamal Kunj Bldg., Behind Ruia College, Lady Jahangir Road, Matunga, Dr Gayatri Bharadwaj Gayatris Clinic Dr. Gayatri Bharadwaj,A-1/5, jayanti C.H.S., J.S.D. Road, Mulund (W), Dr Deepak Kotar Kotkar Clinic Malpani prides, next to Raymonds Showro, Nashik Nashik Dr Rashmikant M Shah KRS Derma Care Dr Anant Gaikwad Lavanya Skin Care & Hair Clinic & Cosmetology Centre B/18, Modern Roopkamal society, Next to Om Sai Motors, Opp. Anandvan Ashram, 426/427 S. V. Road, Kandivli (West), salmanbhoira@yahoo.c o.in dr_medhekar@yahoo.c o.in gayatribharadwaj@yah oo.co.in deepakkotkar@gmail.c rotaryrms@gmail.c Sai Siddhi Cplex, 1st floor, Opp. Shiv Sena Shakha / Hotel Shrirath, dr_anantg@rediff.c Shivaji page 2 / 6

3 DrRachita Dhurat LTM, Medical College & LTMG Hospital, Chowk,Ambarnath (E) Thane Department of Dermatology & STD, LTM, Medical College & LTMG Hospital, Sion, Dr Rashid Shaikh Meher Hospital Near Payal Cinema, Bhiwandi Thane Chitra Nayak Nair Hospital Department of Dermatology, T. N. Medical College and BYL Nair Ch Hospital, Dr. A.L. Nair Road, Dr Gautam Dethe Dr Pranit Farande Navi Corporation General Hospital Urban Health Centre Navi Corporation General Hospital, Urban Health Centre Sector 10 Vashi Navi Sector 10, Vashi, Navi o.in n Dr Chetan Oberai Oberais Clinic Dr Chetan Oberai,101, Centr poi nt, 18th Road, near Ambedkar Gardan, Cembur (E), Dr Rajan T D Rajans Clinic Dr. Rajan T. D102-B, Samrock Apts., Juhu Lane, Off. S. V. Road, Andheri (W), Dr R Torsekar Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital Kalwa, Thane Thane Dr Indur Ramchandani Ramchandanis Clinic Dr Indur Ramchandani,Kemps Corner, 206 Doctor Centre, Next to Shalimar Hotel, above Litolire, Kemps Corner, rajan.td@gmail.c nandutorse@yahoo.co m ramchandani.indur@gm ail.c page 3 / 6

4 Details of Ethics Cmittee Dr Anil Gosavi Sassoon Hospital Department of Skin and VD, BJ Medical College and Sassoon General Hospital, Near Pune Station, Pune-1 Pune Dr Ravindra Dargainya Shivam Nursing He Shrenik CHS Ltd., Sector-2, Charkop, Kandivali (W), Dr Satish Udare Udares Clinic 26-A, Shanti Center, Second Floor Above Parichay Hotel Sector -17, Vashi, Navi Dr Sunil Vartak Vartak Clinic Flat no 112, B wing, Rajan cplex, above Annapurna sweets, Nashik Road Nashik Dr Sunil Petkar Yash Skin Care Centre 205, Nirman Vyapar Kendra, 2nd Flr, Above Navratna Restaurant, Sec.-17, Vashi, Navi Dr Tushar Jagtap Zen Polyclinic 2/13 Amrut nagar, Opp Highway society, Bandra east, dranilgosavi@hotmail.c ravindra_dargainya@ya hoo.c satish.udare@gmail.co m sunil.vartak@gmail.c drpetkar@hotmail.c drtusharj@yahoo.co.in of Cmittee Approval Status Date of Approval Is Independent Ethics Cmittee? clinical ethics forum Approved 11/11/2011 Yes Disha Independent Ethics cmittee Institutional Clinical Ethics Cmittee Institutional Ethics Cmittee Institutional Ethics Cmittee of BYL Nair Charitable Hospital and TN medical College Approved 18/04/2011 Yes Approved 13/07/2011 No Approved 15/09/2011 No Submittted/Under Review Institutional Ethics Submittted/Under Cmittee, Department Review of Pharmacology, Grant Medical College and Sir J.J. group of Hospitals Staff and Research Approved 04/07/2011 No No No page 4 / 6

5 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Rand Sequence Method of Concealment Blinding/Masking Society Status Not Applicable Health Type Patients Date Condition genital herpes caused due to Herpes simplex virus 2 Type Details Intervention Viracure cream Topical application thrice a day for 14 days Cparator Agent Placebo cream Topical application thrice a day for 14 days Age Fr Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Male or Female patients with age more than 18 years and diagnosed clinically with Genital Herpes. 2. Patients with positive Herpes Simplex Virus - 2 (HSV- 2) DNA detected by Polymerase Chain Reaction (PCR) test. 3. Patients in blister phase or presented within 3 days of onset of herpetic lesion. 4. Patients in good general health and willing to abstain fr sexual contact during the study. 5. Written informed consent signed by patient and willing to cply with the study procedure. Exclusion Criteria Details 1. Patients who have received antiviral therapy in the preceding 14 days or immunodulator therapy within 30 days prior to screening. 2. Patients with history of immunodeficiency or other conditions which could interfere with study assessments at the discretion of Investigator. 3. Patients with active infection other than Genital Herpes such as Herpes zoster ophthalmicus, cplication of herpes zoster: visceral involvement, motor neuropathies, encephalitis, cerebrovascular cplications, Severe disseminated infection: (more than 20 lesions outside the primary affected dermate). 4. Pregnant and lactating female patients. 5. Patients with serum creatinine > 1.5 times ULN or SGOT/SGPT > 3 times ULN. 6. Patients with uncontrolled diabetes. (Rand blood sugar > 300 mg/dl or at the discretion of the Investigator). 7. Known HIV positive patients. 8. Expected use of any other medications that may interfere with efficacy assessment during the treatment period e.g. antiviral, immunodulatory, steroids or antibiotics. 9. Patients who have earlier participated in any other clinical trial within one month prior to screening. Cputer generated randization Pre-numbered or coded identical Containers Outce Assessor Blinded Primary Outce Outce Timepoints Change in viral shedding Secondary Outce Outce Timepoints Mean change in duration of sympts page 5 / 6

6 Powered by TCPDF ( REF/2011/04/ Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Time to cplete healing of lesions Proportion of patients showing cplete absence of sympts Investigator's and Patient's Global Assessment Proportion of patients showing formation of new lesions Total Sample Size=136 Sample Size fr =136 09/05/2011 Years=1 Months=1 Days=0 Not Applicable Cpleted on Day 7, 10 and Day14/Early termination On day 2, 4, 7, 10 and Day14/Early termination Successful chemotherapy of HSV infections has been achieved by the intravenous, oral and topical routes of drug administration. When infection is limited to the skin, topical therapy should be considered because of convenience; reduced systemic exposure to drug side effects; and the potential, with the use of skin penetration enhancers, of higher concentrations of antiviral agents at the site of viral replication than might be achieved by systemic drug delivery. Topical antiviral treatment has been effective in patients with muco-cutaneous HSV infection and in primary genital herpes. Viracure cream in preclinical studies appears to have prise as a topical treatment for genital herpes infection. So in order to evaluate safety and efficacy of Viracure in humans, this study in immunocpetent patients with Genital Herpes due to HSV-2 infection is planned. page 6 / 6