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临床试验/CTRI/2025/08/093335
CTRI/2025/08/093335尚未招募不适用

Effect of individualized homeopathic medicines in cases of atopic dermatitis in age group 10 to 35 years with SCORAD assessment - A case study design.

Dr Deepti Mahesh Yesade1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Change in SCORAD Score from base (0 Month) line to end of treatment.(3rd Month)

研究概览

简要总结

This clinical study assesses the efficacy of individualized homeopathic medicines in managing atopic dermatitis (AD) among 50 patients aged 10–35 years, using the validated SCORAD (Scoring Atopic Dermatitis) tool. Conducted over 4 years, the single-arm case study design excludes severe cases (SCORAD >70%), comorbidities, or long-term steroid users. Participants receive remedies tailored to symptom totality (itch, redness, oozing, lichenification, sleep loss), with plain coconut oil as the sole adjunct. SCORAD scores—evaluating lesion extent, intensity, and subjective symptoms—are measured at baseline and monthly follow-ups until remission. Statistical analysis (paired t-tests/Wilcoxon tests) will determine significance (p<0.05) in score reduction. Secondary objectives include analyzing frequently prescribed remedies (e.g., *Sulphur*, *Graphites*) and symptom patterns. The study addresses a critical evidence gap, as prior homeopathic AD trials involved small cohorts. By demonstrating non-invasive, personalized treatment potential, it aims to reduce reliance on conventional therapies (corticosteroids/immunosuppressants) and improve quality of life. Ethical approval and informed consent are secured, with vernacular (Marathi) documents ensuring participant accessibility. Outcomes may inform integrative dermatology protocols in India’s high-AD-burden setting.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
10.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patients with age 10 to 35 yrs 2) Patients with both sexes 3) Patients having SCORAD calculator percentage upto 70% are included in study 4)Patients of all socioeconomic group are included in study.

排除标准

  • Patients with SCORAD calculator percentage more than 70% are excluded from study 2) Patients with atopic dermatitis along with severe allergic rhinitis and asthma 3) Patients who are using long term steroid treatment and long term antiallergic drugs for atopic dermatitis 4) Patient suffering from life threatening or chronic conditions or immune compromised.
  • Pregnant and lactating women.

结局指标

主要结局

Change in SCORAD Score from base (0 Month) line to end of treatment.(3rd Month)

时间窗: 0-Month and 3rd Month

次要结局

未报告次要终点

研究者

发起方
Dr Deepti Mahesh Yesade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Deepti Mahesh Yesade

SJPESs Homoeopathic Medical College and Hospital

研究点 (1)

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