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J Res Educ Indian Med . 2012; 18(2): 93-100


EFFICACY AND SAFETY OF POLY HERBAL FORMULATION-1, FAS-3 KIT AND FLUCONAZOLE IN FEMALE PATIENTSWITH VAGINOSIS / VAGINITIS

KULKARNI CHANDA, DEB JARITA, MISHRA DEVESH, DIAS MARY, MHASKAR RITA, A.S. MOHAMMED.




Abstract

Context: Vaginosis/vaginitis is one of the commonest symptoms in gynaecological outpatient setting and involves multiple causative organisms – bacteria, fungi and protozoa. The Available treatment options produce a variety of adverse effects and do not decrease recurrence.Aims: The purpose of this study was to examine if poly herbal formulation WH-1 has better efficacy and safety profile compared to the modern medication available for treatment of vaginosis/vaginitis. Methods and Material: The present open labelled, randomized trial in adult women, with diagnosis of vaginosis/vaginitis, involved study patients in two groups who received either – WH-1 or standard treatment [FAS-3 kit or fluconazole], based on microbiological evaluation. Efficacy Outcome measures were assessed subjectively, clinically and microbiologically, while safety was assessed subjectively and using biochemical investigations. The data was analysed using unpaired‘t’ test, χ2 test, and ‘t’ test as appropriate. Results: Between the groups comparison for demographic profile and chronicity of infection did not show significant difference. The clinical and microbiological improvement was comparable in two groups. The microbiological improvement in patients from both WH-1 and FAS-3 kit treated groups was similar while the adverse effects were significantly lower in patients treated with WH-1 [P < 0.05]. CConclusions: The efficacy outcome measures withpoly herbal preparation WH-1 was found to be similar compared to standard treatment with lesseradverse effects. WH-1 may therefore be considered as a safer and alternative treatment option insubjects with vaginosis/vaginitis. However, studies involving long term treatment and follow up inlarger number of patients are necessary to confirm the findings.

Key words: WH-1, FAS-3 kit, fluconazole, vaginosis, vaginitis, clinical evaluation, medicinal plants, Poly herbal formulations, Woodfordia floribunda, Cyperus scariosus, Bombax malabaricum,Symplocos racemosus and Caesalpinia bonduc.






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