CTRI/2018/01/011171已完成2 期
An open label, Phase II, Clinical Study to evaluate the efficacy and tolerability of Arnophyte Cream formulation for pain reduction in patients with recurrent genital herpes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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