Kiev, Ukraine (PRWEB) October 15, 2008
Ekomed LLC has completed a phase II clinical study of Dzherelo (Immunoxel) in 57 patients with seasonal flu.
A clinical trial with Ekomed's herbal product Dzherelo in patients with seasonal flu has shown the product to be effective in all three endpoints: the duration of overall flu symptoms was decreased by approximately 30% in the Dzherelo group, the duration of flu-associated fever was decreased by almost half, and clinical complications were five-fold less frequent in Dzherelo group than in the control group. No side effects attributable to Dzherelo were observed.
This open label phase II clinical trial of Dzherelo, an oral immunomodulator, addressed the benefit of the botanical extract in patients with respiratory influenza infection. The trial was conducted during the winter-spring 2007-2008 flu season in Ukraine. Outpatients who attended three regional clinics were randomly divided into two groups and administered either symptomatic treatment (control, N=28) or Dzherelo (N=29). The clinical endpoints such as clinical symptoms, fever, and disease complications were registered. The results for the main outcome of therapy - the duration of symptoms - were on average 5.1 days and 7.14 days for Dzherelo-treated patients and controls, respectively. Thus, Dzherelo significantly reduced the duration of symptoms by 2.04 days (P=0.0001). The second measured endpoint was the duration of fever which in the Dzherelo and control groups lasted 2.97 and 5.57 days, respectively, corresponding to a shortened duration among Dzherelo recipients by 2.6 days (P=0.0000007). Finally, there were 2 (7.1%) flu-related clinical complications in the Dzherelo group and 11 (37.9%) among those who did not receive the immunomodulator - a difference that was highly significant by Fisher's exact two-way test (P=0.004). No adverse effects associated with use of Dzherelo were observed at any time during study.
The abstract of these clinical findings was accepted as a poster presentation: "Effect of immunomodulator Dzherelo (Immunoxel) in treatment of seasonal flu" at the Sixth World Congress on Vaccines, Immunization and Immunotherapy held on 23-25 September 2008 in Milan, Italy. The results of the current study are expected to be published shortly in a peer-reviewed journal.
In earlier published clinical trials the oral immunomodulator Dzherelo (Immunoxel) was shown to be safe and effective as an adjunct therapy in tuberculosis patients, including patients with multi-drug (MDR-TB) and extensively drug resistant TB (XDR-TB). Similar benefits were observed previously in patients who were infected with HIV, with or without co-infection with TB. Dzherelo was recommended by the Ministry of Health of Ukraine for the seasonal flu indication and as an adjunct immunomodulating agent for tuberculosis in 1999.
Mr. Volodymyr Pylypchuk, the Director of Ekomed company, commented: "Our results support the originally identified indication of Dzherelo for alleviation of flu symptoms almost ten years ago. We are nevertheless deeply satisfied that this season's study confirms our prior investigations which were published in the Ukrainian language and thus have remained largely unknown in the English-speaking world. Dzherelo is sold in Ukraine primarily for seasonal cold indication and over half a million satisfied patients lend support to findings of the latest study. We are confident that our observations will be reproduced in other countries with different forms of flu virus."
Earlier this year Ekomed established a partnership with Zodiac Capital Limited - a publicly listed investment banking group based in Sydney Australia. This agreement will assure worldwide global access to Dzherelo (Immunoxel) as a safe and effective treatment option for seasonal flu. Dr. Allen Bain, a pharmacologist at Zodiac, noted the potential for a major impact of Immunoxel in several different diseases associated with widely varying infectious agents: "Continued clinical success with Immunoxel in the treatment of both viral and bacterial infections further supports the value of this natural product in the immunotherapy of important diseases."
Ekomed LLC is Ukrainian research-driven phyto-pharmaceutical company dedicated to serve patients first. Established 15 years ago, Ekomed discovers, develops, manufactures and markets botanical products to address unmet medical needs. The Company undertakes ethically-responsible basic and clinical research efforts to provide affordable treatment options to patients. Ekomed also strives to publish its research results in reputable medical journals. For more information, visit http://www.ekomed.com.ua
For media and product queries contact:
CEO and Scientific Director
pylypchuk @ bk.ru
Dr. Allen Bain
Zodiac Capital Limited
allen.bain @ zodiaccap.com