CTRI/2026/01/101338招募中2/3 期
A double-blind, randomized, placebo-controlled trial of individualized Dioscorea villosa for the treatment of acute paronychia among adults
D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2026年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
Acute hand infections, often due to puncture wounds, are classified as superficial involving skin and subcutaneous tissues or deep involving deeper structures (tendon sheaths, fascial planes, joints, or bone), with superficial types being more common, and paronychia is one of the most frequent forms, arising from disruption of the protective barrier between the nail and surrounding tissue, occurring spontaneously or after trauma, and may affect a single nail or multiple nails if drug-induced. This outlines a double-blind, randomized (2:1), placebo-controlled clinical trial evaluating individualized Dioscorea villosa in adults with acute paronychia, with 108 participants recruited from a homoeopathic medical college skin and surgery OPD. The primary outcome is time to resolution of pain over 21 days measured by the Numerical Rating Scale, measured at baseline and subsequently on the 1st, 2nd, 5th, 7th, 14th and 21st day with secondary assessment of nail-related quality of life using the NAIL-Q, measured at baseline, 7th, 14th and 21st day. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals.
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
- •Age between 18 and 65 years.
- •Patients suffering from Acute paronychia [ICD-11 code: EE13.0]
- •Any one of the following symptoms of sufficient magnitude should be present as listed below: a.
- •Pain is sharp and agonizing when pricking is first felt.
- •Nails are brittle.
- •Pain spread, especially from the abdomen to distant parts.
- •Any symptoms better by stretching out and moving about.
排除标准
- •1.Patient is denying consent to participate.
- •2.Patients with paronychia requiring surgical intervention at baseline.
- •3.Patients with a history of contact dermatitis from steroids, onychomycosis, psoriasis, lichen planus, or recent steroid/antibiotic treatment for paronychia.
- •4.Patients agreed not to use any other topical products.
- •5.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •6.Pregnant and puerperal women, lactating mothers.
- •7.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, institutionalized subjects, mentally incompetent people.
- •8.Habit of tobacco chewing, smoking, and other forms (s) of substance abuse and/or dependence.
- •9.Self-reported immune-compromised state.
- •10.Already undergoing homeopathic treatment for chronic disease for the last 2 weeks.
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: Baseline, 1st, 2nd, 5th, 7th, 14th and 21st day.
次要结局
- NAIL-Q(Baseline, 7th day, 14th and 21st day.)
研究者
Rajat Kumar Pal
D N De Homoeopathic Medical College and Hospital
研究点 (1)
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