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

Phase 2/3

Not yet recruiting

• Conditions: Vitiligo,

• Registration Number: CTRI/2023/03/050278
• Lead Sponsor: National Research Institute Of Unani Medicine For Skin Disorders

Brief Summary

Vitiligo is a cosmetic dermatological defect, but it has a very prominent social and psychological impact on the patient. It is a depigmenting skin disorder characterized by the selective loss of melanocytes,which in turn leads to pigment dilution in the affectedarea of the skin. Thecharacteristic lesion is totally amelanotic, non-scaly, chalky-white maculewith distinct margins. Vitiligo is a common dermatological as well as cosmetic and social problem with prevalence 1% to 2% ofthe world population .In India it is between 3% to 4%.The incidence of vitiligoas reported by various workersin different cities of India canbe 2.9% in Goa, 8.8% in Delhi. However most authors say that its incidence is around is 4% which is howeverdefinitely more as compared to worlds population of 1%. Several single and compound formulations have been used to treat vitiligo by many ancient Unani physicians, but some of them are not yet scientifically evaluated on modern parameters. Hence, this A Randomized, Parallel Group, Open Label, Active Controlled ClinicalStudy is planned to evaluate the Efficacy and Safety of *Roghan-i-Baras* in the Management of *Baraá¹£* (Vitiligo). Participants fulfilling inclusion and exclusion criteria will receive either test or control drug as per randomization. In test group participants will start with Roghan-i-Baras and in control group participants will start with Methoxsalen 1% , for the duration of 16 weeks. Baseline and last follow up and laboratory investigations will be done.

Statistical analysis : After completion of the study, data obtainedwill be analysed statistically by using an appropriate statistical test to evaluate the significance of results. p<0.05will be considered significant.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-28
• Study Start: 2023-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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 <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.

Exclusion Criteria

• 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 patient’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)	4th,8th,12th and 16th week
2.Change in Vitiligo Disease Activity (VIDA) Score.	4th,8th,12th and 16th week
3.Improvement in Global Assessment (IGA)	4th,8th,12th and 16th week
4.Photographic Assessment	4th,8th,12th and 16th week

Secondary Outcome Measures

Name	Time	Method
Systemic safety Assessment	4th,8th,12th and 16th weeks.

Trial Locations

Locations (1)

National Reasearch Institute Of Unani Medicine For skin Disorders; 🇮🇳 Hyderabad, TELANGANA, India

National Reasearch Institute Of Unani Medicine For skin Disorders

🇮🇳Hyderabad, TELANGANA, India

Dr Mohd Ashik

Principal investigator

9005370209

ansariashiq891@gmail.com