Symptomatic treatment of acute tonsillo-pharyngitis patients with a combination of Nigella sativa and Phyllanthus niruri extract.
Acute tonsillopharyngitis is characterized by tonsil or pharyngeal inflammation and mostly is a virus in origin; thus, treatment that covers both the inflammation and inadequate immune response against the pathogenic organism is needed. NSPN extract containing Nigella sativa and Phyllanthus niruri extracts has both antiinflammatory and immunomodulatory effects. A comparative, parallel, randomized, double-blind, placebo-controlled study with a treatment period of 7 days was conducted to examine clinical effectiveness of Nigella sativa and Phyllanthus niruri extract (NSPN extract). Of 200 enrolled patients, 186 patients completed the study, 12 patients withdrew and 2 patients were principally screened failure but inadvertently included. NSPN capsules, each containing 360 mg Nigella sativa and 50 mg Phyllanthus niruri extracts, were orally administered 3 times 1 capsule daily for 7 days. At Hour 5 or 6 of the first dosing of study medication, the sore throat assessed as swallowing pain and difficulty, was markedly alleviated in the NSPN group. In line with the significant alleviation of pain, from Days 0 to 2 of treatment, subjects in the NSPN group also needed significantly less escape âanalgesicâ therapy (paracetamol tablets) than those in the placebo group. At the end of treatment (Day 7), a significantly greater proportion of patients in the NSPN group than in the placebo group had their sore throat completely relieved. NSPN extract was also found to be safe and well tolerated in acute tonsillopharyngitis patients. This study proved significant benefits of NSPN extract in the treatment of acute tonsillopharyngitis as compared to placebo.
Dirjomuljono
M
M
Department of Ear, Nose, Throat, Faculty of Medicine, University of Airlangga/Dr. Soetomo General Hospital, Surabaya, Jakarta, Indonesia. eleanora.anggiara@dexa-media.com
Kristyono
I
I
Tjandrawinata
R R
RR
Nofiarny
D
D
D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002214:Capsules; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D031881:Nigella sativa / Q000009:adverse effects / Q000737:chemistry*; D010147:Pain Measurement; D010612:Pharyngitis / Q000188:drug therapy*; D029803:Phyllanthus / Q000009:adverse effects / Q000737:chemistry*; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014069:Tonsillitis
D002214:Capsules; D004338:Drug Combinations; D010936:Plant Extracts