Efficacy of Somraji Gel with and Without Swayambhuva Guggulu in Childhood Vitiligo (Svitra): An Open Label Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage re-pigmentation in vitiligo patches, as assessed by the Vitiligo Area Scoring Index (VASI), compared between the two groups at baseline and defined follow-up intervals.
研究概览
简要总结
Title: Efficacy of Somraji Gel with and without Swayambhuva Guggulu in Childhood Vitiligo (Svitra): An Open Label, Randomized Controlled Trial
Summary: Vitiligo (Svitra) is a skin condition that causes white patches due to loss of skin pigment. It is common in children and often leads to social stigma and psychological stress. Modern treatments like steroids and phototherapy have limitations, side effects, and high costs. Ayurveda describes effective remedies, especially Somraji (Bakuchi) and Swayambhuva Guggulu, but these have not been fully tested in children through scientific trials.
Before testing in children, the newly prepared Somraji gel will be first checked for safety in animals as per OECD guidelines. Tests include acute dermal toxicity and skin sensitization to see if the gel causes any irritation, allergy, or toxic effect. The results are expected to confirm that the gel form is safer and less irritating than the traditional oil form, with no harmful reactions observed. This ensures the gel is safe to proceed for human clinical use.
This study aims to evaluate whether Somraji gel (an improved and safer gel form of Somraji oil) works better alone or in combination with Swayambhuva Guggulu (a classical Ayurvedic internal medicine) for treating childhood vitiligo.
A total of 70 children (aged 5–16 years) with vitiligo will be randomly divided into two groups:
- Group A: Somraji Gel alone (topical application with sun exposure).
- Group B: Somraji Gel + Swayambhuva Guggulu tablets (oral).
The treatment will last 8 weeks, with a 4-week follow-up. Outcomes will be measured by:
- Primary outcome: Improvement in pigmentation (Vitiligo Area Scoring Index – VASI).
- Secondary outcomes: Symptom reduction, changes in melanin index (colorimetry), improvement in quality of life (DLQI), and safety profile.
If successful, the study may provide a safe, effective, affordable, and user-friendly Ayurvedic protocol for managing childhood vitiligo, reducing reliance on costly or side-effect-prone modern therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children of age group 5-16 years of either gender.
- •2.Woods lamp positive for vitiligo.
- •3.Patients with Sadhya Lakshana of Svitra (Peeta chavi, Pandu varna, Ruksha).
- •4.Patients having Svitra patches with normal tactile sensation.
- •5.Patients with Twak svetata mandatorily, and preferably any or all of Roukshya, Kandu, Daha, Vivarnata (Roma) in the subjective symptom scoring.
- •7.Patients having history of steroids or PUVA therapy (after a washout period of 1 month.).
排除标准
- •1.Patients not willing to participate in the study, and beyond the age range 5-16 years.
- •2.Patients with Asadhya Lakshana of Svitra [Raktalom, Hastha-Pada Tal Jatam, Guhyam Jatam(Sex organ), Aushtheshu(Lip), Agnidagdhaja, Janmajata(Hereditary)].
- •3.Patients currently on other systems of medication or Ayurvedic medication.
- •4.Vitiligo associated with malignant melanoma, albinism and psoriasis.
- •5.Patient suffering from other systemic diseases (like bronchial asthma, etc.) & autoimmune disorders (Eg: Celiac disease, Type I Diabetes mellitus, Inflammable Bowel Disease, etc.).
结局指标
主要结局
Percentage re-pigmentation in vitiligo patches, as assessed by the Vitiligo Area Scoring Index (VASI), compared between the two groups at baseline and defined follow-up intervals.
时间窗: day 0,30,60,90
次要结局
- Change in subjective symptom scores (e.g., itching, burning, dryness, etc.) over the intervention period, measured through a standardized symptom scoring scale.
- Change in melanin index values, as measured by colorimetry, from baseline to the end of the study period.
- Improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI), by comparing baseline and post-treatment scores.(day 0,60,90)
- Safety and dermal tolerance of Somraji gel, based on findings from acute dermal toxicity and sensitivity studies conducted during the preclinical phase.(Pre Clinically)
研究者
Geetika Vashishth
All India Institute of Aturveda