TY - JOUR
T1 - Symptomatic treatment of acute tonsillo-pharyngitis patients with a combination of Nigella sativa and Phyllanthus niruri extract
AU - Dirjomuljono, M.
AU - Kristyono, I.
AU - Tjandrawinata, R. R.
AU - Nofiarny, D.
PY - 2008/6
Y1 - 2008/6
N2 - 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 "analgesic" 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 tonsillo-pharyngitis patients. This study proved significant benefits of NSPN extract in the treatment of acute tonsillopharyngitis as compared to placebo.
AB - 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 "analgesic" 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 tonsillo-pharyngitis patients. This study proved significant benefits of NSPN extract in the treatment of acute tonsillopharyngitis as compared to placebo.
KW - Acute tonsillopharyngitis
KW - Nigella sativa
KW - Phyllanthus niruri
UR - http://www.scopus.com/inward/record.url?scp=45949096851&partnerID=8YFLogxK
U2 - 10.5414/CPP46295
DO - 10.5414/CPP46295
M3 - Article
C2 - 18541126
AN - SCOPUS:45949096851
SN - 0946-1965
VL - 46
SP - 295
EP - 306
JO - International Journal of Clinical Pharmacology and Therapeutics
JF - International Journal of Clinical Pharmacology and Therapeutics
IS - 6
ER -