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. 2021 Sep 29;20(1):233-240.
doi: 10.1515/jcim-2021-0353. eCollection 2023 Mar 1.

A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)

Ifra Abdul Qaiyyum  1 , Mohammad Nawab  1 , Munawwar Husain Kazmi  2
Affiliations

A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)

Ifra Abdul Qaiyyum et al. J Complement Integr Med. .

Abstract

Objectives: Kalaf (Melasma) is an acquired facial hypermelanism. It has direct impact on patient's quality of life and leads to development of various personality disorders. Lack of effective treatment and recurrences have drawn the attention of researcher to find alternative treatment. This study aimed to evaluate safety and efficacy of a topical Unani formulation in the management of melasma.

Methods: We conducted a prospective randomized controlled clinical study on the participants diagnosed with melasma. The participants (n=72) randomized into test (n=36) and control (n=36) groups. Sixty participants (n=30 in each group) completed the duration of therapy. The participants of the test group were treated with a classical Unani formulation and control group with hydroquinone 4%. The primary end point was change in mean MASI score and secondary end point was improvement in quality of life after eight weeks of treatment.

Results: The Unani formulation reduced 40.5% mean MASI score (17.31 ± 9.58 to 10.28 ± 5.92) in comparison to 32% reduction in mean MASI score (20.58 ± 9.49 to 13.92 ± 7.38) in the control group after eight weeks of treatment. When comparing with baseline the difference in MASI score was found statistically significant in both groups (p<0.05). On intergroup comparison, the change in MASI score between both groups was not statistically significant (p>0.05). In addition, MQOL and DQLI also improved significantly in both groups.

Conclusions: This study concluded that the Unani formulation and the control drug were equally effective and safer in the management of melasma.

Keywords: MASI; Unani; herbal; hyperpigmentation; melanin; quality of life.

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