Randomized, Clinical Study to Evaluate the Efficacy and Safety of Roghan-i-Baras in management of Baras(Vitiligo)
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2023/03/050278
- Lead Sponsor
- ational Research Institute Of Unani Medicine For Skin Disorders
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <5 new lesions in the last month, atleast 1% body surface
area.
5.Subjects with <15 lesions in the last 3 months, atleast 1% body surface
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
The following patients will be excluded
•Patients aged <18 years or >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
•KnowncasesofImmunocompromisedstates(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction in Vitiligo Area Scoring Index (VASI) <br/ ><br>2.Change in Vitiligo Disease Activity (VIDA) Score. <br/ ><br> <br/ ><br>3.Improvement in Global Assessment (IGA) <br/ ><br>4.Photographic AssessmentTimepoint: 4th,8th,12th and 16th week
- Secondary Outcome Measures
Name Time Method Systemic safety AssessmentTimepoint: 4th,8th,12th and 16th weeks.