Clinical study of Unani drug in comparison to conventional drug in the treatment of vitiligo (white patches)

Phase 2

Not yet recruiting

Conditions: Vitiligo,

Registration Number: CTRI/2019/04/018669

Lead Sponsor: Central Research Institute of Unani Medicine

Brief Summary: Baras (Vitiligo) is a chronic depigmenting skin disorder that affects 1-2% of the world population. It involves a complex interaction of environmental and genetic factors leading to progressive destruction of melanocytes characterized by chalky or milky white lesions. There is strong evidence of genetic predisposition of Baras (Vitiligo) from monozygotic twins and family studies.

Baras (Vitiligo) may develop at any age; onset has been reported from birth to 81 years of age. The peak age of onset is between 10 and 30 years; in 50% of cases, lesions develop within the first two decades of life.

Baras (Vitiligo) causes cosmetic disfigurement in patients, which may significantly impair their quality of life (QoL). The social stigma and matrimonial discriminations are associated with Baras (Vitiligo). The everyday stress and stigma associated with Baras (Vitiligo) may have psychological consequences such as depression and negative self-image. Furthermore, many cultures assume that patients with depigmented areas of skin carry leprosy, and therefore those with Baraá¹£ (Vitiligo) may be thrown out of society, for example into an â€˜untouchableâ€™ class.

There is no safe and effective treatment for Baras (Vitiligo) available in any system of medicine to regain pigmentation. Treatment options available across the systems have their own limitations in offering relief to this cosmetic problem. The incidence of side effects is too high as reported both with topical as well as systemic therapy, at the same time, surgical options available are self-hazardous, unless disease becomes stable, and there is hardly any medication available in conventional medicine to control the disease process and to check the aggravation. The steroids and PUVA therapy which are usually employed for the above purpose are hepato-toxic and carcinogenic in the long-term use.

There is a need to focus on two issues one is to arrest the disease process and the other is to induce re-pigmentation. So, there is an ample need to search for a safe and effective drug, which may induce cosmetically acceptable re-pigmentation and control the disease process.

Keeping in view the magnitude of the problem and the need to regain the cosmetically acceptable pigmentation, and based on recent reports which suggest the efficacy and safety of various single as well as compound Unani formulations in the management of Baraá¹£ (Vitiligo), a clinical study titled â€œA Single-Blind, Randomized, Parallel Group, Controlled Clinical Study to compare the Efficacy and Safety of a Unani Drug â€“ Atrilal (O+T) with Conventional Drug â€“ Psoralen (O+T) in the Treatment of Baras (Vitiligo)â€ has been designed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients of any sex aged18-40 years Non-segmental vitiligo with chronicity of 6 months to 2 years Vitiligo involving more than equal to 2% body surface area (BSA) Patients with less than 5 new lesions in the last month Patients with less than 15 lesions in the last 3 months Patients who have not taken systemic treatment in the last 4 weeks Patients who have not taken topical treatment in the last 2 weeks.

Exclusion Criteria

Patients aged less than 18 years or more than 40 years Segmental vitiligo/ lip-tip or universal vitiligo/ vitiligo with leucotrichia Non-Segmental vitiligo with chronicity of less than 6 months or more than 2 years History of photosensitivity/ photo exaggerated dermatoses Pregnant or Lactating Women Significant Pulmonary/ Cardiovascular/ 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitiligo Disease Activity (VIDA) Score	VASI at baseline, 4th week, 8th week, 12th week and end of the 16 week REST at baseline and end of the trial
Photographic Assessment	VASI at baseline, 4th week, 8th week, 12th week and end of the 16 week REST at baseline and end of the trial
Investigators Global Assessment (IGA)	VASI at baseline, 4th week, 8th week, 12th week and end of the 16 week REST at baseline and end of the trial
Global Assessment (PGA) on VAS	VASI at baseline, 4th week, 8th week, 12th week and end of the 16 week REST at baseline and end of the trial
Vitiligo Area Severity Index (VASI)	VASI at baseline, 4th week, 8th week, 12th week and end of the 16 week REST at baseline and end of the trial

Secondary Outcome Measures

Name	Time	Method
Lab investigations (Hemogram, LFT, RFT, ECG, CXR, CUE,	At baseline, and end of the 16th week

Trial Locations

Locations (1): Central Research Institute of Unani Medicine
🇮🇳
Hyderabad, TELANGANA, India
Central Research Institute of Unani Medicine
🇮🇳Hyderabad, TELANGANA, India
Mozakkir Husain
Principal investigator
8859109398
khan93b@gmail.com