A clinical trial to study the efficacy and safety of Viracure cream in patients with Genital Herpes virus 2 infection.
- Conditions
- Health Condition 1: null- genital herpes caused due to Herpes simplex virus 2
- Registration Number
- CTRI/2011/05/001706
- Lead Sponsor
- Piramal Life Sciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 136
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 from sexual contact during the study.
5. Written informed consent signed by patient and willing to comply with the study procedure.
1. Patients who have received antiviral therapy in the preceding 14 days or immunomodulator 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, complication of herpes zoster: visceral involvement, motor neuropathies, encephalitis, cerebrovascular complications, Severe disseminated infection: (more than 20 lesions outside the primary affected dermatome).
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. (Random 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, immunomodulatory, steroids or antibiotics.
9. Patients who have earlier participated in any other clinical trial within one month prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in viral sheddingTimepoint: Day 0, 2, 4, 7, 10 and Day14/Early termination
- Secondary Outcome Measures
Name Time Method Investigator's and Patient's Global AssessmentTimepoint: on Day 7, 10 and Day14/Early termination;Mean change in duration of symptomsTimepoint: Day 0, 2, 4, 7, 10 and Day14/Early termination;Proportion of patients showing complete absence of symptomsTimepoint: Day 0, 2, 4, 7, 10 and Day14/Early termination;Proportion of patients showing formation of new lesionsTimepoint: On day 2, 4, 7, 10 and Day14/Early termination;Time to complete healing of lesionsTimepoint: Day 0, 2, 4, 7, 10 and Day14/Early termination