title: Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection.
abstract: OBJECTIVE
  To investigate the safety and efficacy of the formulation HD-03/ES capsules in the management of patients with chronic hepatitis B infection.
  
  
  METHODS
  A total of 25 patients were recruited to the study and were given HD-03/ES, two capsules twice daily for six months. Clinical assessment of symptoms and signs were done using the " clinical observation table" once a month before and after the treatment. Biochemical investigations of total bilirubin, ALT, AST, serum protein for liver function tests were done every month after initiating treatment. Serum was analyzed for HBV markers for HBsAg, HBeAg and HBV DNA at baseline, 4 and 6 mo after therapy using ELISA kits from Roche.
  
  
  RESULTS
  After 6 mo of therapy with HD-03/ES, a significant reduction of ALT values from 66.5 +/- 11.1 to 39.1 +/- 5.2 (P < 0.01) and a significant HBsAg loss (52%, P < 0.001), HBeAg loss (60%, P < 0.05) and HBV DNA loss (60%, P < 0.05) was observed. Adverse effects were mild and never warranted withdrawal of the drug.
  
  
  CONCLUSIONS
  The results of this pilot study indicate that HD-03/ES might be a safe and effective treatment for chronic hepatitis B infection and a long-term multicentric comparator trial is warranted and under way.
authors: Lifeline Rigid Hospitals, Kilpauk, Chennai, India.
authors: J S
authors: JS
authors: Rajkumar
authors: M G
authors: MG
authors: Sekar
authors: S K
authors: SK
authors: Mitra
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology / Q000821:virology; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; C119007:HD 03 polyherbal; D006513:Hepatitis B e Antigens; D010936:Plant Extracts; D000410:Alanine Transaminase
references: J Hepatol. 2002 Feb;36(2):263-70
references: 11830339
references: Am J Gastroenterol. 2006;101 Suppl 1:S13-8
references: 16448447
references: Chin Med J (Engl). 2003 Sep;116(9):1312-7
references: 14527355
references: Arch Intern Med. 2006 Jan 9;166(1):49-56
references: 16401810
references: Gut. 2003 Mar;52(3):420-4
references: 12584227
references: J Hepatol. 2000 Feb;32(2):300-6
references: 10707871
references: Lancet. 2003 Dec 20;362(9401):2089-94
references: 14697813
references: Hepatology. 2000 Oct;32(4 Pt 1):847-51
references: 11003633
references: N Engl J Med. 2003 Feb 27;348(9):808-16
references: 12606735
references: Gastroenterology. 1982 Jul;83(1 Pt 1):114-7
references: 7075936
references: Clin Infect Dis. 2004 Nov 1;39(9):1353-62
references: 15494913
references: Am J Gastroenterol. 2006 Feb;101(2):297-303
references: 16454834
references: J Antimicrob Chemother. 2003 Mar;51(3):481-5
references: 12615847
references: Cancer. 1988 May 15;61(10):1942-56
references: 2834034
references: N Engl J Med. 2004 Sep 16;351(12 ):1206-17
references: 15371578