Health Condition 1: null- Early signs & symptoms of recurrent HSV-2 Health Condition 2: B008- Other forms of herpesviral infections
Conditions
Interventions
Intervention1: Arnophyte Cream-Extract of Ficus arnotianna: route: Arnophyte cream for topical application
duration: five times a day.
Control Intervention1: NIL: NIL
Sponsors
Piramal Enterprises Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with at least one recurrence during the past 12 months and typically associated with ulcerative lesions (lesion which undergoes prodrome (pain, burning, itching ) vesicle, ulcer/soft crust and/or hard crust formation) 2. Male or female outpatient between the ages of 18- 60 years. 3. Females of child bearing age must have a negative pregnancy test and practice a reliable method of contraception (intrauterine device or combined contraceptives) for at least 3 months prior to enrollment visits and during the remaining study period 4. Patients must agree to abstain from the use of anti-inflammatory medications (including aspirin and NSAIDS), systemic steroids and analgesics during the treatment period until healing occurs 5. Patients must agree to abstain from the use of any topical treatments in the lesion area (e.g. moisturizers, herbal oils or herbal creams) during the treatment period until healing occurs 6. Patients must agree to abstain from any mechanical disruption of the prodromal area or lesion (i.e., scrubbing, lancing, shaving the area, rubbing with alcohol etc.) 7. Patients willing to give written and video informed consent and willing to follow up as per the protocol
Exclusion criteria
Exclusion criteria: 1. Treatment or prevention with other systemic or topical antiviral agents; within 4 weeks prior to study drug administration 2. Immunodeficiency disorders such as HIV or receiving cancer chemotherapy 3. Previous herpes vaccine 4. Cytotoxic or immunosuppressive drugs, including systemic corticosteroids or steroids within 3 months, Fluorouracil or its pro-drugs, tricyclic antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory agents for viral infection 5. Herpes zoster ophthalmicus, affecting mucous membrane oral cavity, complication of herpes zoster: visceral involvement, motor neuropathies, encephalitis, cerebrovascular complications, Severe disseminated infection: (more than 20 lesions outside the primary affected dermatome) 6. Clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab 7. Pregnant, nursing and/or lactating females 8. Subjects with history of uncontrolled diabetes mellitus. 9. History of intolerance or hypersensitivity to the cream components 10. Significant skin disease (such as atopic dermatitis, eczema, psoriasis or chronic vesiculobullous disorders) that would interfere with assessment of lesions 11. Subjects receiving any systemic Ayurvedic, Homeopathic or Herbal drug; continuously for one month, three months prior to screening visit. 12. History or evidence from physical examination of tuberculosis 13. Unwillingness to refrain from using topical medical, OTC or cosmetic products in or around the genital area during the herpes recurrence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of treatment on reduction of pain Number of days of illnessTimepoint: (Baseline/Day1, Day 2, 4, 7& 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HSV-2, associated signs & symptoms 2. Lesion healing and size reduction 3. Physiciansâ?? Global Assessment 4. Patientsâ?? Global Assessment scale 5. The Changes in the Genital Herpes Specific Quality of Life. 6. Adverse Event 7. Rescue/Concomitant MedicationTimepoint: (Day 1, 2, 4, 7 & 15) | — |
Countries
India
Contacts
Public ContactKavita Salkar
Piramal Enterprises Limited
Outcome results
None listed