A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)
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Ifra Abdul Qaiyyum
and
Munawwar Husain Kazmi
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.
Funding source: Central Council for Research in Unani Medicine, Ministry of AYUSH, Government of India, New Delhi
Award Identifier / Grant number: An Academic Trial
Acknowledgments
Authors are thankful to the Director General, Central Council for Research in Unani Medicine, Ministry of AYUSH, Government of India, New Delhi for providing financial support and resource materials for the study.
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Research funding: This work was funded by Central Council for Research in Unani Medicine, Ministry of AYUSH, Government of India, New Delhi as an academic trial.
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Author contributions: Ifra Abdul Qaiyyum developed protocol, collected and recorded data and drafted manuscript. Mohammad Nawab developed protocol, analyzed, interpreted data and edited the manuscript. M.H. Kazmi analyzed the data and vetted the manuscript.
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Competing interests: Authors declare that there is no conflict of interest. The funding organization played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report or in the decision to submit the report for publication.
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Honorarium: None declared.
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© 2021 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Reviews
- Does acupuncture improve sexual dysfunction? A systematic review
- Non-alcoholic fatty liver disease – discussed under the light of Unani medicine
- Phytochemistry and pharmacology of Celastrus paniculatus Wild.: a nootropic drug
- Low back pain patients’ perceived effectiveness of utilizing complementary and alternative medicine: a systematic review of qualitative studies
- Efficacy and tolerability of Lavandula angustifolia in treating patients with the diagnosis of depression: a systematic review of randomized controlled trials
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- Psychobiotic interventions attenuate chronic alcohol use-mediated exacerbation of posttraumatic stress disorder in rats: the role of gut-liver axis response
- Evaluation of the toxicity of crude aqueous Pleurotus tuber-regium (Fr.) Singer extract in mice
- Effects of crude methanol extract of Adansonia digitata fruit pulp on Naja nigricollis venom-induce toxicity in Wistar rats
- Integrative medicine approaches to chronic depression: case studies of the recovery process with a three-step path to recovery and significant cure
- Antimicrobial, anti-adhesion, anti-biofilm properties of goji berry (Lycium barbarum) against periodontal bacteria: potential benefits for periodontal diseases
- Method development and validation for quantification of six bioactive compounds (andrographolide, columbin, piperine, gallic, paracoumaric and oleanolic acids) by HPTLC
- Gallic acid a flavonoid isolated from Euphorbia hirta antagonizes gamma radiation induced radiotoxicity in lymphocytes in vitro
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- Halimeda gracilis (Kadarpassi chooranam) Phytochemical analysis and biological significance – a novel Siddha drug
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- Use and perception of complementary and alternative medicine among Iranian psychologists
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- A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense® on 2-hydroxyestrone:16α-hydroxyestrone ratio in premenopausal women
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- A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)
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