A Study to Create and Test a Tool for Measuring the Severity of Vitiligo and Its Response to Treatment.

An Analytical Study to Develop and Validate a Tool for Assessing the Severity of Shvitra and Evaluate Its Concordance Through Intervention. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080330

Enrollment

Registered

2025-02-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: Patient fulfilling 2024 ICD-10-CM Diagnosis Code L80 criteria. Patient presenting with Saadya Lakshana of Shvitra (~Vitiligo) Generalized and segmental stable vitiligo. Patient who will give informed consent

Exclusion criteria

Exclusion criteria: Active vitiligo defined by presence of confetti lesions trichrome lesion and Koebner phenomenon. Pregnant women and breastfeeding or those who have recently delivered a baby within the past 6 months. Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks. Topical steroids within the prior 2 weeks. Currently undergoing UVB light therapy or history of light therapy within the past 8 weeks. Enrolled in a clinical study of any other investigational drug or device. Prescription medication or cosmetics containing: retinoids glycolic acid salicylic acid or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed. Self-reported history of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance as judged by the investigation. Subjects with active vitiligo treatment with other drug system for at least 3 months. Lesions over the palms genital and burnt areas. Subject having another systemic disease and other skin diseases. Subjects with known allergies impaired cardiac hepatic and renal function. History of malignancy. Subjects suffering with Autoimmune disorders. Any other condition or laboratory value that would in the professional opinion of the investigators potentially affect the subject response or the integrity of the data or would pose an unacceptable risk to the subject.

Design outcomes

Primary

Measure	Time frame
Changes in severity of lesion or completion in study period whichever is earlier.Timepoint: 0 day 1 month 2 month 3 month	—

Secondary

Measure	Time frame
This study evaluates changes in the Shvitra Severity Scale vitiligo extent using Wood s lamp melanin content using Mexameter interferon-gamma levels using ELISA and CXCL10 gene expression using RT-PCR in participants treated with Shashilekha Vati internally and Bakuchi Taila externally over 90 days. Clinical validation of the tool will be achieved by correlating these parameters.Timepoint: 0 day 1 month 2 month 3 month	—

Measure

Time frame

This study evaluates changes in the Shvitra Severity Scale vitiligo extent using Wood s lamp melanin content using Mexameter interferon-gamma levels using ELISA and CXCL10 gene expression using RT-PCR in participants treated with Shashilekha Vati internally and Bakuchi Taila externally over 90 days. Clinical validation of the tool will be achieved by correlating these parameters.Timepoint: 0 day 1 month 2 month 3 month

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Countries

India

Contacts

Public ContactDr Anand More

All India Institute of Ayurveda

drmoreanand@gmail.com8830389544

Outcome results