title: Double-blind, placebo-controlled, 1:1 randomized Phase III clinical trial of Immunoxel honey lozenges as an adjunct immunotherapy in 269 patients with pulmonary tuberculosis.
abstract: Safer and shorter antituberculosis treatment (ATT) regimens represent the unmet medical need.
  
  
  
  The patients were randomly assigned into two arms: the first (n = 137) received once-daily sublingual honey lozenge formulated with botanical immunomodulator Immunoxel and the second (n = 132) received placebo lozenges along with conventional ATT. Immunoxel and placebo arms were demographically similar: 102 versus 106 had drug-susceptible TB; 28 versus 20 multidrug-resistant TB (MDR-TB); 7 versus 7 extensively drug-resistant TB (XDR-TB); and 22 versus 20 TB-HIV. The primary end point was sputum smear conversion.
  
  
  
  After 1 month 87 out 132 (65.9%) of Immunoxel recipients became sputum smear negative, whereas 32 out of 127 (25.2%) in placebo group had converted (p < 0.0001). Sputum clearance produced by Immunoxel was equally effective across all forms of TB. In the immunotherapy arm the average weight gain was 2 kg, but placebo recipients gained only 0.6 kg. Immunoxel reduced TB-associated inflammation as evidenced by defervescence and normalization of elevated leukocyte counts and erythrocyte sedimentation rate. No adverse effects were seen at any time. The liver function tests indicate that ATT-caused hepatotoxicity was counteracted by Immunoxel. These results are in agreement with prior 20 trials of Immunoxel conducted over the past 17 years.
  
  
  
  Immunoxel is affordable, safe, effective, fast-acting, commercially available immunotherapeutic intervention to supplement conventional TB chemotherapy. Clinicaltrials.gov ID: NCT01061593.
authors.affiliation: Misheel Clinic of Lung Surgery, Sonsgolyn Street, Ulaanbaatar, Mongolia.
authors.forename: Uyanga
authors.initials: U
authors.lastname: Batbold
authors.affiliation: Regional TB Hospital No 1, Il'yicha Avenue 2, Kharkiv, Ukraine.|Kharkiv National Medical University, Lenin Avenue 4, Kharkiv, Ukraine.
authors.forename: Dmytro O
authors.initials: DO
authors.lastname: Butov
authors.affiliation: Ekomed LLC, Pravdy Avenue 80a, Kiev, Ukraine.
authors.forename: Galyna A
authors.initials: GA
authors.lastname: Kutsyna
authors.affiliation: Sukhbaatar District TB Dispensary, Zaluuchuudin Street, Ulaanbaatar, Mongolia.
authors.forename: Narantsetseg
authors.initials: N
authors.lastname: Damdinpurev
authors.affiliation: Regional TB Dispensary No 3, Traktorskoe Highway 70, Zmiiv, Ukraine.
authors.forename: Elena A
authors.initials: EA
authors.lastname: Grinishina
authors.affiliation: Bayanzurkh District TB Dispensary, Dzhalkhanz Khutagtu Damdinbazaryn Street, Ulaanbaatar, Mongolia.
authors.forename: Otgonbayar
authors.initials: O
authors.lastname: Mijiddorj
authors.affiliation: Regional TB Dispensary No 7, Moskovskyi Avenue 197, Kharkiv, Ukraine.
authors.forename: Mikola E
authors.initials: ME
authors.lastname: Kovolev
authors.affiliation: Ach Medical University, Peace Avenue, Ulaanbaatar, Mongolia.
authors.forename: Khaliunaa
authors.initials: K
authors.lastname: Baasanjav
authors.affiliation: Regional TB Dispensary No 1, Newton Street 145, Kharkiv, Ukraine.
authors.forename: Tatyana S
authors.initials: TS
authors.lastname: Butova
authors.affiliation: Regional TB Hospital No 1, Il'yicha Avenue 2, Kharkiv, Ukraine.
authors.forename: Munkhburam
authors.initials: M
authors.lastname: Sandagdorj
authors.affiliation: NUS Laboratory, Neftiin Street 35, Ulaanbaatar, Mongolia.
authors.forename: Ochirbat
authors.initials: O
authors.lastname: Batbold
authors.affiliation: NUS Laboratory, Neftiin Street 35, Ulaanbaatar, Mongolia.
authors.forename: Ariungerel
authors.initials: A
authors.lastname: Tseveendorj
authors.affiliation: NUS Laboratory, Neftiin Street 35, Ulaanbaatar, Mongolia.
authors.forename: Erkhemtsetseg
authors.initials: E
authors.lastname: Chunt
authors.affiliation: Regional TB Dispensary No 1, Newton Street 145, Kharkiv, Ukraine.
authors.forename: Svetlana I
authors.initials: SI
authors.lastname: Zaitzeva
authors.affiliation: Regional TB Dispensary No 1, Newton Street 145, Kharkiv, Ukraine.
authors.forename: Hanna L
authors.initials: HL
authors.lastname: Stepanenko
authors.affiliation: Kharkiv National Medical University, Lenin Avenue 4, Kharkiv, Ukraine.
authors.forename: Natalia I
authors.initials: NI
authors.lastname: Makeeva
authors.affiliation: Ekomed LLC, Pravdy Avenue 80a, Kiev, Ukraine.
authors.forename: Igor V
authors.initials: IV
authors.lastname: Mospan
authors.affiliation: Ekomed LLC, Pravdy Avenue 80a, Kiev, Ukraine.
authors.forename: Volodymyr S
authors.initials: VS
authors.lastname: Pylypchuk
authors.affiliation: Island Abbey Food Science Ltd, Innovation Way, Charlottetown, PE C1E 2X3, Canada.
authors.forename: John L
authors.initials: JL
authors.lastname: Rowe
authors.affiliation: Department of Public Health, School of Health Sciences, Monash University, Roodepoort, South Africa.
authors.forename: Peter
authors.initials: P
authors.lastname: Nyasulu
authors.affiliation: Immunitor Inc., 365-2906 West Broadway, Vancouver, BC V6K 2G8, Canada.
authors.forename: Vichai
authors.initials: V
authors.lastname: Jirathitikal
authors.affiliation: Immunitor Inc., 365-2906 West Broadway, Vancouver, BC V6K 2G8, Canada.
authors.forename: Allen I
authors.initials: AI
authors.lastname: Bain
authors.affiliation: Immunitor LLC., Peace Avenue 25, Ulaanbaatar, Mongolia.
authors.forename: Marina G
authors.initials: MG
authors.lastname: Tarakanovskaya
authors.affiliation: Sukhbaatar District TB Dispensary, Zaluuchuudin Street, Ulaanbaatar, Mongolia.|Immunitor LLC., Peace Avenue 25, Ulaanbaatar, Mongolia.
authors.forename: Aldar S
authors.initials: AS
authors.lastname: Bourinbaiar
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D045424:Complex Mixtures / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000276:immunology / Q000628:therapy*; D006722:Honey; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D015990:Placebo Effect; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000150:complications / Q000276:immunology / Q000628:therapy*; D014397:Tuberculosis, Pulmonary / Q000150:complications / Q000276:immunology / Q000628:therapy*
chemical_list: D000995:Antitubercular Agents; D045424:Complex Mixtures
keywords: DOT; HIV; HIV-TB; MDR; Mycobacterium tuberculosis; XDR; immunotherapy