A study to check if Somraji gel alone or along with Swayambhuva Guggulu helps in reducing white patches on the skin (vitiligo) in children.

Efficacy of Somraji Gel with and Without Swayambhuva Guggulu in Childhood Vitiligo (Svitra): An Open Label Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094747

Enrollment

Registered

2025-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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. 6.Patients who are willing to participate in study. 7.Patients having history of steroids or PUVA therapy (after a washout period of 1 month.)

Exclusion criteria

Exclusion criteria: 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.)

Design outcomes

Primary

Measure	Time frame
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.Timepoint: day 0,30,60,90	—

Secondary

Measure	Time frame
Change in subjective symptom scores (e.g., itching, burning, dryness, etc.) over the intervention period, measured through a standardized symptom scoring scale. Timepoint: day 0,60,90;Change in melanin index values, as measured by colorimetry, from baseline to the end of the study period. Timepoint: day 0,30,60,90;Improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI), by comparing baseline and post-treatment scores.Timepoint: 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.Timepoint: Pre Clinically	—

Measure

Time frame

Change in subjective symptom scores (e.g., itching, burning, dryness, etc.) over the intervention period, measured through a standardized symptom scoring scale. Timepoint: day 0,60,90;Change in melanin index values, as measured by colorimetry, from baseline to the end of the study period. Timepoint: day 0,30,60,90;Improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI), by comparing baseline and post-treatment scores.Timepoint: 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.Timepoint: Pre Clinically

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Countries

India

Contacts

Public ContactGeetika Vashishth

All India Institute of Ayurveda

ayuarun@gmail.com8506821947

Outcome results