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
- 试验地点
- 2
- 主要终点
- Effect of treatment on reduction of pain
研究概览
简要总结
An Open Label, Phase II clinical trial was conducted at two sites. The treatment was given for a period of 14 days. The primary outcome measured in this trial was assessment of reduction in pain between baseline, day 2, day 4, day 7 and day 15, using the Visual Analogue Score (VAS). The changes in the Quality of Life Index for recurrent genital herpes (GHQoLr) were assessed on baseline, Day 4, Day 7 and Day 15; the physician’s global assessment and patient’s global assessment of the therapy will be performed on baseline, day 2, day 4, day 7 and day 15. Signs and symptoms associated with HSV-2, and healing of the target lesion were assessed using a lesion score, on baseline, day 2, day 4, day 7 and day 15.
Results:
Visual analogue score (VAS)for pain was evaluated on baseline, day 2, day 4, Day 7 and Day 15. The mean VAS score at the baseline was 63.29± 19.45 SD, which was reduced on day 15 visit to 24.66 ± 23.67 SD, showingsignificant reduction in pain, p<0.0001. Complete pain reduction was notedin 6 patients (15%) on or before 6 days of treatment,and 20 patients i.e. 50% patients were relieved from pain at the end of Day 15.
Genital herpes quality of life (GHQoLr)score reduced significantly after 15 days 14.83±8.98 SD as compared to thebaseline 33±2.30 SD, p <0.0001. During the treatment period the mean lesionsize was 1.65 cms at baseline, reduced to 1.34 cms on day 2 (p <0.0001),which was significantly reduced to 0.75 cm, (p <0.0001), on day 7 which wasfurther reduced significantly to 0.34 cm, (p <0.0001), on day 15.
Overall Lesion specific scoresignificantly reduced from 14.55±2.19 SD baseline to 4.53±2.75 SD on Day 15, p<0.0001, whereas tingling, vesiculation and ulceration were completelyreduced. The signs and symptoms like Erythema, itching and burning showed goodreduction i.e. >50%. There was no change found in the crusting of thelesion. The physicians’ global assessment shows that 23 patients (57.5%)patients showed improvement in the range of 75-99%.The Patients’ global assessment shows that 29 patients (72.5%) showedimprovement in the range of 75-99%.
Treatment with the Arnophytecream application showed overall 4 adverse events; the adverse events werecommon cold, diarrhoea, flatulence and pyrexia. These adverse events were notrelated to study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •Male or female outpatient between the ages of 18- 60 years.
- •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
- •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
- •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
- •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.)
- •Patients willing to give written and video informed consent and willing to follow up as per the protocol.
排除标准
- •Treatment or prevention with other systemic or topical antiviral agents; within 4 weeks prior to study drug administration
- •Immunodeficiency disorders such as HIV or receiving cancer chemotherapy
- •Previous herpes vaccine
- •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
- •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)
- •Clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab
- •Pregnant, nursing and/or lactating females
- •Subjects with history of uncontrolled diabetes mellitus.
- •History of intolerance or hypersensitivity to the cream components
- •Significant skin disease (such as atopic dermatitis, eczema, psoriasis or chronic vesiculobullous disorders) that would interfere with assessment of lesions
- •Subjects receiving any systemic Ayurvedic, Homeopathic or Herbal drug; continuously for one month, three months prior to screening visit.
- •History or evidence from physical examination of tuberculosis
- •Unwillingness to refrain from using topical medical, OTC or cosmetic products in or around the genital area during the herpes recurrence.
结局指标
主要结局
Effect of treatment on reduction of pain
时间窗: (Baseline/Day1, Day 2, 4, 7& 15)
Number of days of illness
时间窗: (Baseline/Day1, Day 2, 4, 7& 15)
次要结局
- 1. HSV-2, associated signs & symptoms(2. Lesion healing and size reduction)