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A non-inferiority randomized controlled clinical trial comparing Unani formulations and PUVAsol in non-segmental vitiligo

  • Nazim Husain ORCID logo EMAIL logo , Qamar Uddin , Munawwar Husain Kazmi and Mohd Khalid
Published/Copyright: June 23, 2021
Journal of Complementary and Integrative Medicine
From the journal Journal of Complementary and Integrative Medicine Volume 20 Issue 1

Abstract

Objectives

Greco-Arab medicine is an ancient system of medicine with greater treasure on therapeutics of vitiligo. The trial Unani formulations have not been scientifically explored for their safety and efficacy, but have been repeatedly prescribed by the great Unani physicians in the management of Baraṣ (vitiligo). Hence, these interventions were selected for the trial.

Methods

In this randomized, controlled, open-label clinical trial, 82 participants with non-segmental vitiligo aged 18–40 years were block randomized to either receive Unani interventions or control for 16 weeks. Out of 82 participants, 42 were randomized to the Unani group and 40 were randomized to the control group. The primary outcome measure was change in vitiligo area scoring index (VASI), which was assessed on weeks 4, 8, 12 and 16. The secondary outcome measures included the patient’s global assessment on VAS and investigator’s global assessment based on photographic evaluation at baseline and after the treatment. Safety parameters included hemogram, LFTs, RFTs, CXR, ECG, urine, and stool examinations, which were evaluated at baseline and after the treatment.

Results

The per-protocol analysis was done on 30 participants in each group and the response in Unani group was not inferior to those receiving control group. The mean ± SD of vitiligo area scoring index (VASI) decreased from 4.09 ± 2.87 and 5.50 ± 5.73 at baseline to 3.13 ± 2.20 and 4.29 ± 4.95 at the end of the trial in both the Unani and control groups respectively.

Conclusions

The study inferred that both the interventions are equally effective and well-tolerated in patients with non-segmental vitiligo.

Keywords: Baraṣ ; Habb-i Baras ; Habb-i Hindi ; non-segmental vitiligo; PUVAsol; VASI
Corresponding author: Nazim Husain, Assistant Professor, Department of Moalajat, Luqman Unani Medical College Hospital & Research Center, Bijapur, Karnataka, 586101, India, E-mail:

Funding source: Central Council for Research in Unani Medicine (CCRUM), Ministry of AYUSH, Government of India (https://ccrum.res.in)

Award Identifier / Grant number: 16314222002D

Acknowledgments

The authors express their sincere thanks to Dr. Tasleem Ahmed, Research Officer (Biochemistry), Dr. Syeda Hajra Fatima, Research Officer (Pathology), Technicians of NRIUMSD, and all the patients who participated in this study for their cooperation in conducting the trial.

  1. Research funding: Central Council for Research in Unani Medicine (CCRUM), Ministry of AYUSH, Government of India, New Delhi (https://ccrum.res.in) (Grant no. 16314222002D).

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: The authors have no conflicting financial interests.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Approval taken from Institutional Ethics Committee, CRIUM, Hyderabad.

  6. Trial registration: Clinical Trial Registry of India (www.ctri.nic.in) registration number CTRI/2017/12/010998.

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Received: 2021-02-25
Accepted: 2021-06-09
Published Online: 2021-06-23

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/jcim-2021-0057
Keywords for this article
Baraṣ; Habb-i Baras; Habb-i Hindi; non-segmental vitiligo; PUVAsol; VASI

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  1. Frontmatter
  2. Reviews
  3. Does acupuncture improve sexual dysfunction? A systematic review
  4. Non-alcoholic fatty liver disease – discussed under the light of Unani medicine
  5. Phytochemistry and pharmacology of Celastrus paniculatus Wild.: a nootropic drug
  6. Low back pain patients’ perceived effectiveness of utilizing complementary and alternative medicine: a systematic review of qualitative studies
  7. 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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  11. Effects of crude methanol extract of Adansonia digitata fruit pulp on Naja nigricollis venom-induce toxicity in Wistar rats
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  13. Antimicrobial, anti-adhesion, anti-biofilm properties of goji berry (Lycium barbarum) against periodontal bacteria: potential benefits for periodontal diseases
  14. Method development and validation for quantification of six bioactive compounds (andrographolide, columbin, piperine, gallic, paracoumaric and oleanolic acids) by HPTLC
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  16. Naturopathic knowledge and approaches to managing endometriosis: a cross-sectional survey of naturopaths with experience in endometriosis care
  17. Halimeda gracilis (Kadarpassi chooranam) Phytochemical analysis and biological significance – a novel Siddha drug
  18. Trends in the St. John’s wort (Hypericum perforatum) research literature: a bibliometric analysis
  19. Use and perception of complementary and alternative medicine among Iranian psychologists
  20. Innovative histological and histochemical characterization of tongue biopsies from patients with burning mouth syndrome
  21. 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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