title: Evident stabilization of the clinical profile in HIV/AIDS as evaluated in an open label clinical trial using a polyherbal formulation.
abstract: OBJECTIVE
  The complementary and alternative medicines (CAM) have not been systematically evaluated for the management of HIV/AIDS patients. In a prospective, single-site, open-label, non-randomized, controlled, pilot trial, we evaluated a polyherbal formulation (PHF) for its safety and efficacy in treating subjects with HIV-AIDS.
  
  
  METHODS
  A total of 32 and 31 subjects were enrolled under the PHF and highly active antiretroviral treatment (HAART) arms, respectively, and followed up for a period of 24 months. Plasma viral RNA, CD4 cell count and blood chemistry were monitored at 3-month intervals. Following mid-term safety evaluation, 12 subjects from the PHF arm were shifted to HAART and were followed separately as PHF-to-HAART arm, for the rest of the period.
  
  
  RESULTS
  The HAART arm was characterized by significant improvements in CD4 cell count (154.4 cells/μl/year, P<0.001) and reduction in plasma viral load within 3 to 6 months (-0.431+ 0.004 log 10 IU/month, P<0.001). In contrast, the PHF arm showed a profile of CD4 cell loss at remarkably slower kinetics (14.3 cells/μl/year, P=0.021) and insignificant reduction in the viral load. The PHF and HAART arms did not differ significantly in the occurrence of AIDS-related illnesses over the study period of 24 months. In the PHF-to-HAART arm, the rates of CD4 count and reduction in viral load were significant and comparable to that of the HAART group. In the PHF arm, at 1 month, a significant increase in CD4 cell count and a concomitant decrease in viral load were seen.
  
  
  CONCLUSIONS
  The PHF appears to have provided protection by delaying the kinetics of CD4 cell reduction. Given the several study limitations, drawing assertive inferences from the data is challenging. Future studies with a stringent study design are warranted to confirm these findings.
authors.affiliation: HIV-AIDS Laboratory, Molecular Biology & Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India.
authors.forename: Mangaiarkarasi
authors.initials: M
authors.lastname: Asokan
authors.forename: Imtiaz Nisar
authors.initials: IN
authors.lastname: Lone
authors.forename: Anil Babu
authors.initials: AB
authors.lastname: Mukthey
authors.forename: Paul
authors.initials: P
authors.lastname: Siddhartha
authors.forename: Gayathri
authors.initials: G
authors.lastname: Mariappa
authors.forename: Praveen Kumar
authors.initials: PK
authors.lastname: Kotehal
authors.forename: Bhuthiah
authors.initials: B
authors.lastname: Satish
authors.forename: Eugene
authors.initials: E
authors.lastname: Wilson
authors.forename: Savariraj
authors.initials: S
authors.lastname: Sahayam
authors.forename: Gopinath
authors.initials: G
authors.lastname: Velayutham
authors.forename: Rajalakshmi
authors.initials: R
authors.lastname: Perumal
authors.forename: Karthikeyan
authors.initials: K
authors.lastname: Baskaran
authors.forename: Devanathan
authors.initials: D
authors.lastname: Rengarajan
authors.forename: Ravichandran
authors.initials: R
authors.lastname: Muthusamy
authors.forename: Mariamma
authors.initials: M
authors.lastname: Philip
authors.forename: K C
authors.initials: KC
authors.lastname: Ravindra
authors.forename: Jeelan N
authors.initials: JN
authors.lastname: Basha
authors.forename: Pushpak
authors.initials: P
authors.lastname: Mizar
authors.forename: Gurvinder
authors.initials: G
authors.lastname: Kaur
authors.forename: Narinder K
authors.initials: NK
authors.lastname: Mehra
authors.forename: Tapas K
authors.initials: TK
authors.lastname: Kundu
authors.forename: D K
authors.initials: DK
authors.lastname: Subbakrishna
authors.forename: Kadappa Shivappa
authors.initials: KS
authors.lastname: Satish
authors.forename: Udaykumar
authors.initials: U
authors.lastname: Ranga
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects; D000529:Complementary Therapies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D010936:Plant Extracts; D012367:RNA, Viral