Clinical efficacy and safety of an allopathic treatment and a unani regime in vitiligo

Comparison of clinical efficacy and safety of Unani therapy in the form of systemic UNIM 004 & topical UNIM 005 with sunlight and conventional allopathic therapy in form of PUVA sol and topical mometasone cream in the treatment of clinically stable vitiligo

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/03/006754

Enrollment

300

Registered

2016-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- VITILIGO

Interventions

Intervention1: Group A (Study group, Unani medicine group) UNIM-004(ORAL) UNIM-005 (TOPICAL): Group A (Study group, Unani medicine group): Patients will be given: UNIM-004: Patients will be asked to t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of either sex, aged 18-65 yrs. 2. Vitiligo involving >2% body surface area. 3. Subject with 4. Subject with 5. No systemic treatment in the previous 4 weeks. 6. No topical treatment in previous 2 weeks.

Exclusion criteria

Exclusion criteria: 1. Age 65 years. 2. Pregnant or lactating women. 3. Segmental vitiligo, lip-tip, or universal vitiligo. 4. Significant cardiac, pulmonary & hepato- renal dysfunction. 5. History of photosensitivity/ photo exaggerated dermatoses and connective tissue diseases. 6. Patients with immunocompromised states (including HIV/AIDS) or malignancies (cutaneous or internal). 7. Patient unsure about attending treatment schedule regularly. 8. Patients who do not have a suitable facility for sun exposure.

Design outcomes

Primary

Measure	Time frame
1. To compare relative efficacy of a combination of oral UNIM 004 and lotion UNIM-005 (Unani formulation) and oral PUVAsol and topical mometasone (standard allopathic therapy) in stable vitiligo. 2. To evaluate the safety of combination of oral UNIM-004 and lotion UNIM-005 (Unani formulation) in treatment of vitiligo. 3. To compare the improvement in quality of life in patients with vitiligo treated with the Unani combination vis-a vis the Allopathic combination. Timepoint: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk	—

Measure

Time frame

1. To compare relative efficacy of a combination of oral UNIM 004 and lotion UNIM-005 (Unani formulation) and oral PUVAsol and topical mometasone (standard allopathic therapy) in stable vitiligo. 2. To evaluate the safety of combination of oral UNIM-004 and lotion UNIM-005 (Unani formulation) in treatment of vitiligo. 3. To compare the improvement in quality of life in patients with vitiligo treated with the Unani combination vis-a vis the Allopathic combination. Timepoint: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk

—

Secondary

Measure	Time frame
1. To compare the rapidity of response in vitiligo using Unani treatment vs Allopathic treatment.Timepoint: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk	—

Countries

India

Contacts

Public ContactDr Neena Khanna

AIIMS

neena_aiims@yahoo.co.in011-26593636

Outcome results

None listed

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