An Open, Comparative, Randomized, Parallel, Post Marketing, Multicentric Trial to Compare the Safety and Efficacy of Formula A (Ofloxacin + Ornidazole + Terbinafine Hydrochloride + Clobetasol Propionate) versus Formula B (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate), Formula C (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) and Formula D (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) in the Treatment of Patients with Vaginitis.
Loading...
Date
2014-08
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Vaginitis is among the most
common conditions for which women seek medical care,
with vaginal discharge accounting for approximately 10
million office visits each year. Since there are no published
studies till date that evaluated the Clinical Effectiveness and
Safety of Topical Cream of Formula A [Ofloxacin (0.75 %
w/w) + Ornidazole (2% w/w) + Terbinafine Hydrochloride (1% w/w) + Clobetasol Propionate (0.05% w/w)] compared
to Formula B [Clotrimazole (1%w/w) + Beclometasone
Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5%
w/w)], Formula C [Clotrimazole (1%w/w) + Beclometasone
Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5%
w/w)], and Formula D [Clotrimazole (1%w/w) +
Beclometasone Dipropionate (0.025%w/w) + Neomycin
Sulphate (0.5% w/w)], in mild to moderate vaginitis, hence
we undertook this randomized controlled Post Marketing
Multicentric trial. Materials and methods: Female subjects
diagnosed with mild to moderate symptoms of Vaginitis
were eligible and those fulfilling the subject selection criteria
were randomized to receive either Formula A, Formula B,
Formula C or Formula D for 14 days. The Primary efficacy
measures were assessment of symptoms of Vaginitis i.e.
vaginal pruritis, vaginal irritation, vaginal soreness or pain,
dyspareunia, vaginal erosion and vaginal inflammation and
Secondary efficacy measures were assessment of Physical
characteristics of vaginal discharge, assessment of pH of
vaginal discharge and Microbiological evaluation.
Assessment of Safety was done by recording the
occurrence of adverse drug reactions. Results: The clinical
success rates were comparable and even far better in case
of Formula A group (in vaginal pain, Dyspareunia and
vaginal erosion it was 100 %, in case of vaginal
inflammation it was 92.655 % while in case of vaginal
irritation, it was 94.767 % and vaginal pruritus, it was
87.096 %). Adverse events were mild and self limiting while
it was totally absent in case of Formula A group.
Conclusion: Topical Cream of Formula A is safe and
effective for the treatment of mild to moderate vaginitis.
Description
Keywords
dyspareunia, vaginitis, vaginal erosion, microbiological evaluation
Citation
Chari S V, Rajani Neeta D, Mayekar Rahul, Mungantiwar Ashish A, Saldhana Egbert, Ambekar Shalmali. An Open, Comparative, Randomized, Parallel, Post Marketing, Multicentric Trial to Compare the Safety and Efficacy of Formula A (Ofloxacin + Ornidazole + Terbinafine Hydrochloride + Clobetasol Propionate) versus Formula B (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate), Formula C (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) and Formula D (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) in the Treatment of Patients with Vaginitis. Indian Medical Gazette. 2014 Aug ; 148 (8): 288-296.