Herbal Supplement For Patients With HIV & TB - Phase II Clinical Trial Of Botanical Immunomodulator Dzherelo (Immunoxel)

Main Category: Tuberculosis
Also Included In: Complementary Medicine / Alternative Medicine;  HIV / AIDS
Article Date: 21 Jun 2008 - 1:00 PDT

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Ukrainian company Ekomed LLC announced this week that it had published Phase II clinical trial of its herbal supplement Dzherelo (Immunoxel) in patients with HIV and tuberculosis. The study appeared in June issue of International Immunopharmacology (2008; Volume 8(6): Pages 845-851). Abstract of the paper can be found online at PubMed -- medical information service of the National Institutes of Health (NIH) - Click here to see abstract.

Open-label, Phase II clinical trial was conducted in 40 TB/HIV co-infected patients to evaluate the effect of oral immunomodulator Dzherelo (Immunoxel) on immune and viral parameters. The anti-retroviral therapy naïve patients were divided into two equal groups which received same anti-tuberculosis therapy (ATT). The arm A, which served as a control, received Isoniazid (H); Rifampicin (R); Pyrazinamide (Z); Streptomycin (S); and Ethambutol (E), and arm B received 50 drops of Dzherelo twice per day in addition to the daily dose of HRZSE. After 2 months the total CD3+ lymphocytes increased from 728 to 921 cells/μl (P=0.025) in Dzherelo recipients, whereas in the control group they decreased from 651 to 585 cells (P=0.25). CD4 T-cell numbers expanded in Dzherelo arm (174 to 283; P=0.00003) but declined in ATT group (182 to 174; P=0.34). The ratio between CD4/CD8 cells improved in Dzherelo arm (1.244>1.536; P=0.007) but deteriorated in ATT arm (1.213>0.943; P=0.002). The percent of CD3+HLA-DR+ activated lymphocytes had fallen in ATT group (22.6>20.5; P=0.004), but rose in Dzherelo recipients (21.5>30.5; P=0.0001). The changes in CD20+ B lymphocytes were insignificant in both arms (28.4%>28.6%; P=0.4) and (27.2%>26.7%; P=0.38). No difference was seen in the amount of CD3-CD16+CD56+ natural killer (NK) cells in arm A (21.3%>22.6%; P=0.1), while in Dzherelo recipients they declined significantly (19.9%>14.5%; P=0.0026). The viral load, measured by plasma RNA-PCR, decreased in Dzherelo group (P=0.002), but increased in ATT group (P=0.03).

The study concluded that Dzherelo has a favorable effect on the immune status and viral burden in TB/HIV patients when given as the immunomodulating adjunct to TB drugs. Dzherelo is an extract from several plants grown in Ukraine that have been used safely as food or for medicinal purposes for several centuries. Being derived from botanical sources and with established record of safety since its approval by the Ministry of Health of Ukraine in 1997, Dzherelo has been used by an estimated 500,000 people so far.

Scientific Director of Ekomed, Mr. Volodymyr Pylypchuk, commented on this occasion: "The publication of our study in peer-reviewed journal is an important milestone for us. Our data shows that Dzherelo can be useful as an immune adjuvant for therapy of AIDS and tuberculosis -- two leading infectious diseases of global importance. Results of this Phase II trial support earlier clinical studies and confirm our commitment to the health of global community".

About Ekomed LLC

Founded in 1996, Ekomed is a privately-held company based in Kiev, Ukraine. The company is the leading botanical company that manufactures over 26 different multiherbal preparations for a variety of health disorders. For more details, please visit the company website at www.ekomed.com.ua