Adjunctive Use of Green Color Charged Virgin Coconut Oil versus Virgin Coconut Oil Alone in the Management of Superficial Fungal Infections and Nonspecific Dermatitis A Comparative Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- 5D Pruritus Scale
研究概览
简要总结
Fungal infections are among the most common dermatological conditions worldwide affecting millions of individuals across all age group. Virgin Coconut Oil has proven anti fungal properties and Green Color has bactericidal effect. This research aims to study the combined effects of Green Color and Virgin Coconut Oil. This randomised, double-blind, parallel group trial will compare the efficacy of Green Color Charged Virgin Coconut Oil in patients with superficial fungal infections and nonspecific dermatitis. The study will enroll adult participants aged 18–60 years and randomize them into two groups: one receiving Green Color Charged Virgin Coconut Oil and the other Virgin Coconut Oil, both along with standard antifungal therapy. The primary outcome measures will include clinical symptoms such as itching redness scaling and lesion size assessed over a 4-week period using validated scales 5 D Pruritus Scale for itch NRS Scoring for redness and lesion measurement with Ruler Metric Scale. Secondary outcomes will assess quality of life using the Dermatology Life Quality Index DLQI.This study aims to provide scientific evidence for the potential synergistic effect of Green Color Charged Virgin Coconut Oil in improving patient outcomes in superficial fungal infections and nonspecific dermatitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Participants with superficial fungal infection and non specific dermatitis.
- •2 Participants currently receiving the standardized conventional anti fungal treatment either oral or topical as per dermatological practice guidelines.
- •3 Willingness to continue the conventional treatment regimen throughout the study period.
- •4 Willing to provide informed consent 5 Willing to adhere to all study instructions and follow up visit.
排除标准
- •1 Severe systemic or dermatological conditions 2 Known allergy to coconut oil 3 Immunocompromised status 4 Pregnant or lactating women 5 Participants not receiving any form of conventional treatment for superficial fungal infection or non specific dermatitis 6 Individual unable or unwilling to comply with follow up visits and study protocol.
结局指标
主要结局
5D Pruritus Scale
时间窗: Baseline Day 0 then on day 7 then day 14 and day 28
次要结局
- Numeric Rating Scale
- Dermatological Life Quality Index(Baseline Day 0 and Day 28)
- Ruler Metric Scale(Baseline Day 0 and Day 28)
研究者
Upasana Pathak
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women