title: Efficacy and safety of Indigo naturalis extract in oil (Lindioil) in treating nail psoriasis: a randomized, observer-blind, vehicle-controlled trial.
abstract: Treating nail psoriasis is notoriously difficult and lacks standardized therapeutic regimens. Indigo naturalis has been demonstrated to be safe and effective in treating skin psoriasis. This trial was conducted to evaluate the efficacy and safety of refined indigo naturalis extract in oil (Lindioil) in treating nail psoriasis. Thirty-one outpatients with symmetrically comparable psoriatic nails were enrolled. Lindioil (experimental group) or olive oil (control group) was applied topically to the same subjects' two bilaterally symmetrical psoriatic nails twice daily for the first 12 weeks and then subjects applied Lindioil to both hands for 12 additional weeks. Outcomes were measured using Nail Psoriasis Severity Index (NAPSI) for five nails on one hand and for the single most severely affected nail from either hand. The results show a reduction of NAPSI scores for the 12-week treatment for the Lindioil group (49.8% for one hand and 59.3% for single nail) was superior to the reduction in the scores for the control group (22.9%, 16.3%, respectively). There were no adverse events during the 24 weeks of treatment. This trial demonstrates that Lindioil is a novel, safe and effective therapy for treating nail psoriasis.
authors.affiliation: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung, Taiwan; School of Traditional Chinese Medicine, Chang Gung University, Taoyuan, Taiwan. Electronic address: lin1266@adm.cgmh.org.tw.
authors.forename: Yin-Ku
authors.initials: YK
authors.lastname: Lin
authors.affiliation: Biostatistics Consultation Center, Department of Public Health, and Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Lai-Chu
authors.initials: LC
authors.lastname: See
authors.affiliation: Department of Dermatology, Chang Gung Memorial Hospital at Taipei, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Yu-Huei
authors.initials: YH
authors.lastname: Huang
authors.affiliation: Department of Dermatology, Chang Gung Memorial Hospital at Taipei, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Ya-Ching
authors.initials: YC
authors.lastname: Chang
authors.affiliation: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung, Taiwan.
authors.forename: Teng-Cheng
authors.initials: TC
authors.lastname: Tsou
authors.affiliation: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung, Taiwan.
authors.forename: Tung-Yi
authors.initials: TY
authors.lastname: Lin
authors.affiliation: Biostatistics Consultation Center, Department of Public Health, and Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Na-Ling
authors.initials: NL
authors.lastname: Lin
mesh_terms: D027901:Acanthaceae / Q000737:chemistry; D000328:Adult; D000368:Aged; D002851:Chromatography, High Pressure Liquid; D004365:Drugs, Chinese Herbal / Q000032:analysis / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D009260:Nail Diseases / Q000188:drug therapy* / Q000473:pathology; D009262:Nails / Q000187:drug effects / Q000473:pathology; D010946:Plants, Medicinal / Q000737:chemistry; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C530990:Qingdai compound
keywords: Indigo naturalis; Indirubin; Nail psoriasis; Psoriasis; Traditional Chinese medicine