Randomized, Clinical Study to Evaluate the Efficacy and Safety of Roghan-i-Baras in management of Baras(Vitiligo)

A Randomized, Parallel group, Open Label, Active controlled Clinical study to Evaluate the Efficacy and Safety of Roghan-i-Baras in the management of Baras (Vitiligo)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050278

Enrollment

Registered

2023-03-02

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Intervention1: Roghan-i-Baras: Dosage Form: Oil Dose : To be applied locally as per required once in the morning Duration: 16 weeks Composition 1. Post Baikh Sheetraj Hindi Plumbago zeylancia Linn. 10

Eligibility

Inclusion criteria

Inclusion criteria: 1.The participants will be included in the study on the basis of the following criteria: 2.Subjects of any sex aged 18-60 years 3.Non-Segmental Vitiligo with Chronicity of 6 months to 3 years 4.Subjects with area. 5.Subjects with area. 6.Subjects who have not taken systemic treatment in the last 4 weeks 7.Subjects who have not taken topical treatment in the last 2 weeks 8.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF

Exclusion criteria

Exclusion criteria: The following patients will be excluded •Patients aged 60 years •Segmental Vitiligo/ Lip-Tip/ Universal Vitiligo •History of photosensitivity/ photo exaggerated dermatoses and Connective Tissue Diseases •Pregnant or Lactating Women •Significant Cardiovascular/ Pulmonary/ Hepato-renal Dysfunction •Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (cutaneous or internal) •Patients not willing to attend treatment schedule regularly •Patients not having a suitable facility for sun exposure. •Any other clinical condition that in the opinion of the investigator would compromise the patientâ??s safety or successful participation in the trial. •Known allergy, sensitivity or intolerance to the study drug or any of its ingredients •Participants with active alcohol intake and/or drug abuse •Participants not willing to sign the ICF and to attend treatment schedule regularly.

Design outcomes

Primary

Measure	Time frame
1.Reduction in Vitiligo Area Scoring Index (VASI) 2.Change in Vitiligo Disease Activity (VIDA) Score. 3.Improvement in Global Assessment (IGA) 4.Photographic AssessmentTimepoint: 4th,8th,12th and 16th week	—

Secondary

Measure	Time frame
Systemic safety AssessmentTimepoint: 4th,8th,12th and 16th weeks.	—

Countries

India

Contacts

Public ContactDr Mohd Ashik

National Research Institute Of Unani Medicine For Skin Disorders

aarzu763@gmail.com9032519286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026