Efficacy and tolerability of two intravaginal formulations containing clindamycin plus clotrimazole in women with vaginal infections: A pilot study

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Abstract
Pharmacology, Toxicology and Biomedical Reports,2015,1,1,27-34.
Published:27th Feb, 2015
Type:Research Article

Efficacy and tolerability of two intravaginal formulations containing clindamycin plus clotrimazole in women with vaginal infections: A pilot study

Daswani Bharti Ramchand1, Naik Shilpa2, Palewar Meghana3, Ghongane Balasaheb1, Sambarey Pradeep2 Bharadwaj Renu3

1Department of Pharmacognosy, BJ Government Medical College, Pune. India.

2Department of OBGY, BJ Government Medical College, Pune. India.

3Department of Microbiology, BJ Government Medical College, Pune. India.

Abstract:

Aims: To compare the effectiveness and tolerability of ClinSupV3 (soft gelatine capsule) versus ClinSupV3-ER (Extendedrelease tablet) in vaginal infections. Subjects and Methods: Following baseline vaginal examination, 66 women having clinical diagnosis of vaginal infection were randomized to receive three doses [once daily] of ClinSupV3 (SG-group) or ClinSupV3-ER (ER-group) per vagina and followed up for assessing resolution of clinical and microbiological evidence of vaginal infection by 8th day; maintenance of clinical and microbiological cure at 29th day; and occurrence of side effects. Statistical analysis used: Results were presented using descriptive statistics and analyzed by Chi square and Fischer’s Exact test. Results: 27 women from SG-group and 30 women from ER-group completed the study. In SG-group, 69.23% had complete cure and 7.69% had partial remission at 8th day of which 88.89% maintained remission, while in ER-group 73.68% women had a complete cure of which 85.71% maintained remission on 29th day. Delayed remission was observed in 25% women from SG-group and 60% women from ER-group, while none of the women experienced intolerable adverse effects. Conclusion: Both formulations containing clindamycin plus clotrimazole were effective, as empiric therapy, in inducing and maintaining microbiological as well as clinical remission in women with clinical diagnosis of vaginal infection to a similar extent. Amongst individual infections, trichomoniasis showed least response. Neither of the two formulations could treat trichomoniasis by end of first week, though there was a delayed response of similar magnitude with both formulations.