title: Antiparasitic and disease-modifying activity of Nyctanthes arbor-tristis Linn. in malaria: An exploratory clinical study.
abstract: BACKGROUND
  An unceasing threat of drug resistance continuously poses demand for new antimalarial drugs. A scientific assessment of traditionally used antimalarial plants through reverse pharmacology is crucial for a fast track drug discovery. An Ayurvedic plant Nyctanthes arbor-tristis Linn. - (Parijat) is being used in clinical practice and had shown antimalarial activity, with a parasite clearance in 76.6% of 120 patients, in an earlier clinical study.
  
  
  OBJECTIVE
  To further explore antimalarial potential of the plant through additional objective markers.
  
  
  METHODS
  An open-labelled observational study was conducted at M.A. Podar Hospital - Ayurveda (MAPH-A) after ethics committee approval. Administration of a paste of 5 fresh leaves, thrice a day for a week was a standard practice for management of malaria at MAPH-A. Clinical activity of N. arbor-tristis was evaluated by monitoring pyrexia, parasitemia and morbidity score (MS) in twenty patients. In addition, immune and biochemical markers and organ functions were monitored for objective markers of response. Student's paired-'t' test was applied to assess statistical significance.
  
  
  RESULTS
  Ten out of 20 patients showed both fever and parasite clearance, which was confirmed by polymerase chain reaction. Remaining ten patients had persistent but decreasing parasitemia. Four of them needed chloroquine as a fail-safe procedure. Irrespective of the degree of parasitemia all the patients showed decrease in MS. There was also an increase in platelet count and normalization of plasma lactic acid. There was a good clinical tolerability and an improvement in organ function. The inflammatory cytokines showed a reduction; particularly in TNF-α within a day.
  
  
  CONCLUSIONS
  At the given dosage, N. arbor-tristis showed disease-modifying activity; early clinical recovery with a decline of TNF-α and a gradual parasite clearance. Further studies with a standardised formulation for dose-searching and optimizing the treatment schedule are needed in a larger sample size.
  
  
  BACKGROUND
  The process of trial registration had not begun when the study was conducted in 2000.
authors.affiliation: ICMR Advanced Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Centre, Kasturba Health Society, Vile Parle (West), Mumbai 400056, India. Electronic address: cgodse@gmail.com.
authors.forename: Chhaya S
authors.initials: CS
authors.lastname: Godse
authors.affiliation: Yerala Medical Trust's Ayurvedic Medical College and Hospital (YMTA), Sector 4, Kharghar, Navi Mumbai 410210, India.
authors.forename: Prakash S
authors.initials: PS
authors.lastname: Tathed
authors.affiliation: CPA Lab, Hematopathology and Molecular Diagnostics Division, Louisville, KY 40220, USA.
authors.forename: Sameer S
authors.initials: SS
authors.lastname: Talwalkar
authors.affiliation: ICMR Advanced Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Centre, Kasturba Health Society, Vile Parle (West), Mumbai 400056, India.
authors.forename: Rama A
authors.initials: RA
authors.lastname: Vaidya
authors.affiliation: ICMR Advanced Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Centre, Kasturba Health Society, Vile Parle (West), Mumbai 400056, India.
authors.forename: Ashok J
authors.initials: AJ
authors.lastname: Amonkar
authors.affiliation: Centre for Molecular Parasitology, Department of Microbiology and Immunology, Drexel University College of Medicine, Philadelphia, PA 19129, USA; ICMR Advanced Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Centre, Kasturba Health Society, Vile Parle (West), Mumbai 400056, India.
authors.forename: Akhil B
authors.initials: AB
authors.lastname: Vaidya
authors.affiliation: ICMR Advanced Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Centre, Kasturba Health Society, Vile Parle (West), Mumbai 400056, India.
authors.forename: Ashok D B
authors.initials: AD
authors.lastname: Vaidya
keywords: Antimalarial; Ayurveda; Cytokines; Drug resistance; Nyctanthes arbor-tristis; Plasmodium falciparum; Plasmodium vivax; Reverse pharmacology; TNF-α; Traditional medicine