Efficacy Of Individualized Homoeopathy In The Treatment Of Warts: A Double Blind, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
- 试验地点
- 8
- 主要终点
- Percentage of warts disappeared
研究概览
简要总结
This is a multicentric, Randomized, double blind, placebo controlled study which will be undertaken in the special dermatology clinics operating in the research centers of the Council. The dermatology clinics are managed by trained homoeopathic practitioners with research experience. The clinics provide routine OPD care to patients suffering from dermatological disorders using homoeopathic medicines only. The primary objective is to evaluate response to individualized homoeopathic treatment for disappearance or resolution of warts and secondary objective is to assess and compare the effect of homoeopathic medicine in warts on the basis of Dermatological life quality index (DLQI) questionnaire score and to identify specific HPV genotypes and their correlation with homoeopathic treatment outcomes on a sample of patients. The participants aged 18 to 65 years, both gender will be enrolled under the study. All types of cutaneous warts, single or multiple wherein one wart should be atleast more or equal to 2 mm will be included under the study. The outcome assessment will be done on the basis of percentage of warts disappeared, regression in the size and number of warts (in millimeter scale) to be assessed on fortnightly basis and change in the dermatological life quality index score at baseline, at the end of 1 month, 3rd month and 6th month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •All types of cutaneous warts Single wart sized equal or more than 2 mm/ multiple warts wherein at least one wart should be equal or more than 2 mm.
排除标准
- •Anogenital warts, Bowenoidpapulosis, focal epithelial hyperplasia or seborrhoric keratosis.
- •History of skin cancer Treatment with immune-modulating oral medications like corticosteroids in past 04 weeks Patient on homoeopathic treatment for any disease condition.
- •Self-reporting cases of HIV Pregnant and lactating women Advance disease of any vital organs.
结局指标
主要结局
Percentage of warts disappeared
时间窗: At baseline, 15 days, 1 month, 1.5 months, 2 months, 2.5 months, 3 months, 3.5 months, 4 months, 4.5 months, 5 months, 5.5 months, 6 months
Regression in the Size and number of warts (in millimeter scale)
时间窗: At baseline, 15 days, 1 month, 1.5 months, 2 months, 2.5 months, 3 months, 3.5 months, 4 months, 4.5 months, 5 months, 5.5 months, 6 months
次要结局
- Change in Dermatological life quality index (DLQI) questionnaire score(Baseline, at the end of 1 month, 3rd month and 6th month)
- Identification of specific HPV genotypes in patients suffering from warts on a sample of patients(Baseline)
研究者
Dr Renu Mittal
Central Council for Research in Homeopathy
