title: Safety evaluation and therapeutic efficacy of Habb-e-Asgand, a commonly used antirheumatic polyherbal Unani formulation.
abstract: BACKGROUND
  Rheumatoid arthritis (RA) is a chronic autoimmune disorder. Habb-e-Asgand (HEA) is a polyherbal, Unani formulation widely used in the treatment of RA. Traditional systems of medicine or plant-based drugs are an attractive alternative treatment because of their professed efficacy in curing the disease. Medicinal herbs and herbal formulations are generally considered to be safer than the conventional drugs for RA. Unani drugs are known not to produce toxic effects and are presumed to be nontoxic. However, no objective, verifiable data exists to support the claims of nontoxicity and efficacy.
  
  
  OBJECTIVE
  The present study was designed to evaluate the safety and therapeutic efficacy of HEA in Wistar rats.
  
  
  METHODS
  The study took place at the University College of Medical Sciences and GTB Hospital, University of Delhi, Dilshad Garden, Delhi, India.
  
  
  METHODS
  Oral toxicity studies--one acute (14 d) and one long-term (90 d)--were carried out using three doses of HEA--57.5, 115, and 230 mg/kg body weight (BWT)--in both male and female rats. The research team also carried out a study on antirheumatic activity. The team induced arthritis in three groups of male rats using collagen type II (CII), and for 20 d, one group was treated once weekly with saline; a second group was treated once weekly with methotrexate (MTX) at 0.25 mg/kg BWT IP; and a third group was treated daily with HEA at 115 mg/kg BWT orally. A control group received saline but was not induced with RA.
  
  
  METHODS
  Rheumatoid factor (RF); anticyclic citrullinated peptide (a-CCP) antibody; antinuclear antibody (ANA); and C-reactive protein (CRP) were measured.
  
  
  RESULTS
  The acute and long-term, oral toxicity studies showed that HEA administration did not produce any overt toxicity or mortality and that it was safe at all dose levels tested. No major alterations were observed in hematology, serum biochemistry, necropsy, and histopathology at the therapeutic equivalent dose (ie, 115 mg/kg BWT). HEA administration for 20 d in arthritis-induced rats significantly reduced the levels of autoantibodies and CRP, and the results were comparable with those of MTX, the standard, disease-modifying antirheumatic drug (DMARD).
  
  
  CONCLUSIONS
  The study's results provided evidence that HEA is not toxic at the therapeutic dose. The antiarthritic activity of HEA may be due to its disease-modifying activities, thus supporting the traditional use of this formulation for treatment of RA.
authors: Department of Biochemistry, University College of Medical Sciences, Delhi, India.
authors: Mythily
authors: M
authors: Subramaneyaan
authors: Shagufta
authors: S
authors: Yasmeen
authors: Vinod Kumar
authors: VK
authors: Arora
authors: Asok Kumar
authors: AK
authors: Tripathi
authors: Basu Dev
authors: BD
authors: Banerjee
authors: Rafat Sultana
authors: RS
authors: Ahmed
mesh_terms: D000818:Animals; D018501:Antirheumatic Agents / Q000494:pharmacology* / Q000633:toxicity*; D001169:Arthritis, Experimental / Q000188:drug therapy* / Q000276:immunology; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D001323:Autoantibodies / Q000097:blood; D005260:Female; D008297:Male; D019367:Medicine, Unani; D008727:Methotrexate / Q000009:adverse effects / Q000494:pharmacology; D010936:Plant Extracts / Q000494:pharmacology* / Q000633:toxicity; D011897:Random Allocation; D051381:Rats; D017208:Rats, Wistar; D015430:Weight Gain / Q000187:drug effects
chemical_list: D018501:Antirheumatic Agents; D001323:Autoantibodies; D010936:Plant Extracts; D008727:Methotrexate