Effect of Unani formulation in Dark Spots on face.

Phase 2

Not yet recruiting

• Conditions: Other melanin hyperpigmentation, (2) ICD-10 Condition: L814||Other melanin hyperpigmentation,

• Registration Number: CTRI/2022/07/044251
• Lead Sponsor: Goverrment Unani Medical College And Hospital

Brief Summary

Melasma is common hypermelanosis that typically occurs on sun-exposedareas in the face. The overall prevalence of Melasma in women varies bygeography and population between 1.5% and 33.3%. The estimated prevalenceof melasma in pregnant women is up to 70%. The prevalence of melasma in men assuggested in one simple survey is approximately 20%. It is a cosmeticissue that sometimes cause great psychological suffering. As per one study,which showed that melasma associated with significant impact on health-relatedquality of life. It is characterized by sharply demarcated, blotchy, brownmaculae, usually symmetrical on the cheeks, forehead, sometimes on the upperlip and neck. According to Unani system factors affecting kalaf  includesfrequent exposure to excess abnormal external heat;  Dam-e-Muharraq (charredblood), Sauda-e-Muharraq (charred melancholic blood),  Ghiza-e-Kaseef (indigestiblefood), constant local pressure, pregnancy, liver disease i.e. Du’fal-kabid (liver atony) and Sughàr al-kabid. Although Melasma isasymptomatic it is disfiguring skin disease that has a negative impact on lifeand the self-esteem of effected individuals and causes distress in the patientsas it mainly affects the face. It affects their psychological andemotional wellbeing and often feel bothered, frustrated, embarrassed, anddepressed about their skin appearance.

The physician described various regimenal and pharmacotherapies for themanagement of Melasma in detail. The Pharmacological action of zimad inpresent study exhibits: Jali (detergent), qabiz (astringent), Qasir (Scaling), Ghassal (irrigator), Mubassir (vesicant), Muhammir (rubifecient), Raade-Mawaad (divergent), Mughazzi (nutrient), muhalil-e-awram (anti-inflammatory),antioxidant, antimicrobial, dafa-e-quba (antifungal), mana-e-sartan (anticancer), mana-e-qurooh (antiulcer)properties.

Therefore a clinical trial entitled ’Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma)- A Randomized controlled trial’ is contemplated to evaluate the efficacyof rewandchini with Asl with the objective of improvement in skin lesions andto improve the quality of life of the sufferers of Melasma.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-21
• Study Start: 2022-07-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1 Clinical patients of Kalaf (Melasma) 2 Patients of either sex 3 Patients between 18-50yrs of age 4 Patients with Fitzpatrick skin type III- type V 5 Patient m-MASI score up to 3 (Moderate/Marked) in darkness and ≤ 49% in Area 6 Duration of Melasma ≤ 3yrs 7 Willingness to participate in the study and follow the instructions.

Exclusion Criteria

1 Patients with any systemic illness and malignancies 2 Patients on contraceptive pills 3 Skin sensitivity 4 Severe cases of Melasma (m-MASI score >50%) 5 Pregnancy/ Lactating women 6 Hormonal replacement therapy 7 Topical bleaching agents for at least 1month or chemical peeling or laser at least 4months before the start of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in kalaf melasma as per mMASI score and PGA score	improvement in kalaf melasma as per mMASI score and PGA score on 7th 14th 21st 28th 35th 42nd day

Trial Locations

Locations (1)

Government Unani College and Hospital, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Government Unani College and Hospital, Bangalore

🇮🇳Bangalore, KARNATAKA, India

Dr Wasima Swaleha

Principal investigator

8088260712

wasimaswaleha36@gmail.com