User:Infinitesimus/ImmunoXel

Immunoxel is a herbal product of Ukraine that has been in clinical trials for tuberculosis (including Multi-drug-resistant tuberculosis and Extensively drug-resistant tuberculosis), AIDS, and influenza. Immunoxel is closely related to another product with the Ukrainian tradename "ДЖЕРЕЛО" (pronounced Dzherelo). Both products have been the subject of clinical trials and are considered together in this article. Although Immunoxel and/or Dzherelo have been marketed in Ukraine as an over-the-counter preventive and treatment product against colds and flu for several years, no clinical trial had been published in English language until 2003 and the product was little known outside of Ukraine until Stirling Products and Zodiac Capital joint ventured a license to commercialize the product globally .

Product Description

Immunoxel is an important development in natural medicinal products – it is a phyto-pharmaceutical (derived from plant extracts) that has potent effects on a wide range of viral and bacterial infectious diseases, including tuberculosis. Immunoxel has no known side effects – its predecessor product has been used by and proven safe in more than half a million people over a 12 year period. Immunoxel effectively supports normal immune system function and, at the same time, protects the liver. Since Immunoxel actually modulates the body’s immune system, it is effective in the treatment of a wide variety of infectious diseases, including seasonal flu.

Immunoxel is a phyto-pharmaceutical synthesized from extracts of specific parts of at least 21 herbs (see table). The current formulation of Immunoxel is an ethanol-based concentrate. Administration is by dissolving Immunoxel drop-wise in water and drinking the solution. The usual dosage of Immunoxel is 50 drops in 100 ml water once or twice daily.

Immunoxel is currently manufactured in a Kiev production facility certified by the Ukraine Ministry of Health (compliance with DSTU 4161–2003 manufacturing standard) and is in full compliance with the hygiene requirements of the European Union (14.06.1993 № 93/43). The factory and manufacturing process meet the requirements of international (FAO/WHO) as well as US standards (21 CFR parts 120 &123, and HACCP - Hazard Analysis and Critical Control Points). In the manufacturing process for Immunoxel, strict attention is paid to standardization and quality control, from the source of the constituent plant materials, to the cold extraction processes used in preparing the bulk ingredients, to the validation testing of the final formulation.

Immunoxel plant sources Aloes arborescens Chelidonium majus Glycyrrhiza glabra Urticae dioicae Gnaphalium uliginosum Inula helenium Camelia sinensis Centaurium erythraea Rhodiolae roseae Salvia officinalis Oreganum majorana Acorus calamus Betula pendula Hippophae rhamnoides Calendula officinalis Achillea millefolium Juniperus communis Eleutherococcus senticosus Equiseti arvensis Rosa canina Inonotus obliqus

Clinical Trials

Immunoxel has undergone several open label clinical trials for various infectious and immune-related diseases. Major findings are that: 1. Immunoxel added to ATT provides a higher efficacy than ATT alone 2. Immunoxel maintains efficacy against MDR- and even XDR-TB resistant forms - shortens the time to TB cure for patients with multi-drug resistant TB - reverses HIV antiretroviral drug hepatotoxicity in HIV/HCV coinfected patients.

Most notably, a series of ten Immunoxel clinical trials have been carried out in tuberculosis. Patient selection for each of these trials varied by form of tuberculosis, extent and duration of the infection, and the drug resistance profile of the TB bacteria.

Immunoxel regulatory status 1997-2008

Date	Country	Indication	Status	Reference
1997	Ukraine	Immunomodulator	Dietary supplement	Reg.No.ТU U23732912.002-97
1998-1999	Ukraine	seasonal flu- Immune Adjunct	Dietary supplement	MoH Bulletin UDK No.616.24-002.5-085-038:615.017
1998-1999	Ukraine	Tuberculosis - Immune Adjunct	Dietary supplement	MoH Bulletin UDK No. 616.921.5-085.015.211-084
2006	Ukraine	TB, flu	Functional Foodstuff	Reg. No. TU U15.8-23732912-016:2006
2006	Mongolia	TB, flu	Biologically active product	Reg. No. 646
2007	South Africa	TB, HIV	Complementary medicine	MCC Ref. No. CM420344/07

Product Description

Immunoxel is an oral botanical preparation consisting of aqueous alcohol extract of select medicinal plants: Aloe (Aloe arborescens), Plantain (Plantago major), Sage (Salvia officinalis), Nettle (Urtica dioica), Bird smartweed (Polygonum aviculare), Yarrow (Achillea millefolium), Purple coneflower (Echinaceae purpureae), Tutsan (Hypericum androsaemum), Centaury (Centaurium erythraea), Oregano (Origanum vulgare), Wormwood (Artemisia vulgaris), Immortelle (Helichrysum arenarium), Thyme (Thymus vulgaris), Beggartick (Bidens tripartite), Marigold (Calendula officinalis), Snowball tree fruit (Viburnum opulus), Seabuckthorn fruit (Hippophae rhamnoides), Dog rose fruit (Rosae caninae), Fennel (Foeniculi fructus), Juniper fruit (Juniperi communis), Dandelion (Taraxaci officinalis), Rosewort (Rhodiola rosea), Licorice root (Radix Glycyrrhizae), Sweet-sedge (Acorus calamus), Elecampane (Radix Inulae), Cinquefoil (Potentilla anserine), and Birch tree fungus (Inonotus obliqus).

Published data on HIV

Immunoxel was tested in an open-label, matched-case, comparative trial in 40 HIV patients (20 control, 20 treatment) and several significant effects of Immunoxel were seen after two months treatment.

Possible mechanisms of action

Examples of multiherbal products with clear immunomodulatory effects are Immunoxel/Dzherelo and Anemin, which together modulate cytokines (increase plasma level of IL-2 and decrease TNF-α and also CD-4 and CD-8 cell levels . Many other herbs have been shown to have immunomodulatory effects, eg. astragalus, He Jie Tiang , and many others.

Companies involved with Immunoxel

ImmunoXel is manufactured in Kiev Ukraine by Ekomed LLC. Outside Ukraine, marketing is under license to Zodiac Capital Ltd, of Sydney Australia, joint ventured to Stirling Products Ltd of Sydney Australia. In Nigeria, Innovative Biotech , of Keffi Nigeria, agreed to conduct further clinical testing in HIV/TB and to market Immunoxel in Nigeria.

Literature

1.Chechitiany R, Pylypchuk V, Argzanova O, Prihoda N, Vichrova L, Zagaydanova E, Kutsyna G. Comparative effect of an immunomodulator Immunoxel (Dzherelo) when used alone or in combination with antiretroviral therapy in drug-naïve HIV infected individuals. Int J Biotechnol 2007;9:267-276.

2.Frolov V, Pylypchuk V, Kutsyna G, Chehitiany R, Zagaydanova E, Argzanova O, Urchenko L. New therapeutic option for decreasing ART–related toxicity in HIV/HCV co-infected patients. Second International Workshop on HIV and Viral Hepatitis Co-infection; Jan 12-14, 2006; Amsterdam, The Netherlands. Abstract #20.

3.Kutsyna G, Zagaydanova E, Zaharova I. Effects of a novel immunomodulator in HIV infected individuals. Seventh International Congress on Drug Therapy in HIV Infection, Glasgow, UK, Nov 14-18, 2004. Abstract #224 .

4.Plovetzka IA. Effect of combination of Amizon and phytoconcentrate Dzherelo on humoral immunity of workers in ceramic industry. Probl Ecol Med Gen Clin Immunol 2004;62:109-112.

5.Shapovalova IA. Effect of preparation of plant origin Dzherelo on the level of serum immunoglobulins among adolescents who overcame acute tonsillitis. Probl Ecol Med Gen Clin Immunol 2004;62:132-112.

6.Shapovalova ÿA. Influence of plant derivative drug Dzherelo on macrophage function among teenagers with acute tonsillitis of viral etiology. Probl Ecol Med Gen Clin Immunol 2004;61:135-144.

7.Kutsyna Gÿ, Chechitiany RB, Zagaydanova YG. Effects of immunomodulator Dzherelo on immune signs among HIV-infected patients. Probl Ecol Med Gen Clin Immunol 2003;53:56-59.

8.Bodnar PM, Mykhal'chyshyn HP, Reznichenko VM, Moshchych OP, Pylypchuk VS. Phytoconcentrates Dzherelo and Lizorm in therapy of autoimmune thyroiditis. Lik Sprava 2002;8:127-129.

9.Plovetzka IA. Combination therapy of flu with botanical preparation Dzherelo with Amizon in workers employed at electric bulb plant. Probl Ecol Med Gen Clin Immunol 2004;61:166-171.

10.Chechitiany RB. Influence of plant derivative drug Dzherelo on cellular immunity in patients with chronic persistent herpes infection and chronic fatigue syndrome. Probl Ecol Med Gen Clin Immunol 2003;53:92-99.

11.Chechitiany RB. Influence of plant derivative drug Dzherelo on circulating immune complexes and their molecular content among patients with chronic persistent viral infection of mixed genesis (Epstein-Barr and herpes). Probl Ecol Med Gen Clin Immunol 2004;61:130-134.

12.Kutsyna G, Chechitiany R, Baskakov I, Zagaydanova E, Zaharova I. Influence of a novel immunomodulator to the prevalence of new events opportunistic infections in untreated HIV- infected individuals. 3rd European HIV Drug Resistance Workshop. Athens, Greece. April 4-7, 2005. Abstract #36.

13.Zeleniy ÿÿ. Effectiveness of phytoconcentrate Dzherelo on immune reconstitution of patients with erysipiloid pustulous–necrotic complications. Probl Ecol Med Gen Clin Immunol 2003;53:34-49.

14.Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI. Efficacy of phytopreparation Dzherelo in complex therapy of multi-drug resistant lung tuberculosis. Probl Ecol Med Gen Clin Immunol 2006;71-72:115-126.

15.Zaitzeva SI. Clinical efficacy of phytopreparation Dzherelo and its influence on the functional status of liver in patients with destructive forms of tuberculosis. Probl Ecol Med Gen Clin Immunol 2006;71-72:132-140.

16.Prihoda ND, Arjanova OV, Sokolenko NI, Vihrova LA. Clinical efficacy of phytopreparation Dzherelo in patients with co-morbid pathology: lung tuberculosis in combination with HIV infection. Probl Ecol Med Gen Clin Immunol 2006;71-72:151-161.

17.Barabai Vÿ, Grinevich Yÿ, Zhinchenko Vÿ, Pylypchuk VS. Influence of Dzherelo immunotherapy on effectiveness of radiation treatment of tumors. Probl Ecol Med Gen Clin Immunol 2004;61:67-70.

External links

• [1] Ekomed LLC website
• [2] Stirling Products Ltd website
• [3] Innovative Biotech, in charge of Nigerian clinical trials of Immunoxel
• [4]
• [5]