title: Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis.
abstract: Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.
authors.affiliation: ASA Foundation, New Delhi, India. sannidhi@del3.vsnl.net.in
authors.forename: V S
authors.initials: VS
authors.lastname: Saxena
authors.forename: K
authors.initials: K
authors.lastname: Venkateshwarlu
authors.forename: P
authors.initials: P
authors.lastname: Nadig
authors.forename: H C
authors.initials: HC
authors.lastname: Barbhaiya
authors.forename: N
authors.initials: N
authors.lastname: Bhatia
authors.forename: D M
authors.initials: DM
authors.lastname: Borkar
authors.forename: R S
authors.initials: RS
authors.lastname: Gill
authors.forename: R K
authors.initials: RK
authors.lastname: Jain
authors.forename: S K
authors.initials: SK
authors.lastname: Katiyar
authors.forename: K V
authors.initials: KV
authors.lastname: Nagendra Prasad
authors.forename: K M
authors.initials: KM
authors.lastname: Nalinesha
authors.forename: K
authors.initials: K
authors.lastname: Nasiruddin
authors.forename: J P
authors.initials: JP
authors.lastname: Rishi
authors.forename: J
authors.initials: J
authors.lastname: Roy Chowdhury
authors.forename: P S
authors.initials: PS
authors.lastname: Saharia
authors.forename: B
authors.initials: B
authors.lastname: Thomas
authors.forename: D
authors.initials: D
authors.lastname: Bagchi
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004311:Double-Blind Method; D004338:Drug Combinations; D004804:Eosinophils / Q000166:cytology / Q000187:drug effects; D005260:Female; D029001:Herbal Medicine; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000187:drug effects; D008297:Male; D009079:Mucociliary Clearance / Q000187:drug effects / Q000502:physiology; D009299:Nasal Provocation Tests / Q000379:methods; D010352:Patient Dropouts / Q000706:statistics & numerical data; D010366:Peak Expiratory Flow Rate / Q000187:drug effects / Q000502:physiology; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D010946:Plants, Medicinal / Q000737:chemistry*; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012882:Skin Tests / Q000379:methods; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D010936:Plant Extracts; D007073:Immunoglobulin E