ISSN 0970-7700
 

Original Research 


A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis

Chanda Kulkarni, Jarita Deb, Devesh Mishra, Mary Dias, Rita Mhaskar, A S Mohammed.


Abstract
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 and 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, ÷2 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]. Conclusions: The efficacy outcome measures with
poly herbal preparation WH-1 was found to be similar compared to standard treatment with lesser
adverse effects. WH-1 may therefore be considered as a safer and alternative treatment option in
subjects with vaginosis/vaginitis. However, studies involving long term treatment and follow up in
larger number of patients are necessary to confirm the findings.

Key words: WH-1, FAS-3 kit, fluconazole, vaginosis, vaginitis, clinical evaluation


 
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How to Cite this Article
Pubmed Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. J Res Educ Indian Med . 0; 0(0): -.


Web Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. https://www.jreim-ayushjournal.com/?mno=17999 [Access: March 11, 2024].


AMA (American Medical Association) Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. J Res Educ Indian Med . 0; 0(0): -.



Vancouver/ICMJE Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. J Res Educ Indian Med . (0), [cited March 11, 2024]; 0(0): -.



Harvard Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed (0) A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. J Res Educ Indian Med , 0 (0), -.



Turabian Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. 0. A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. Journal of Research and Education in Indian Medicine, 0 (0), -.



Chicago Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. "A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis." Journal of Research and Education in Indian Medicine 0 (0), -.



MLA (The Modern Language Association) Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed. "A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis." Journal of Research and Education in Indian Medicine 0.0 (0), -. Print.



APA (American Psychological Association) Style

Chanda Kulkarni, Jarita Deb, Devesh Mishra , Mary Dias, Rita Mhaskar, A S Mohammed (0) A prospective, open – labeled, randomized, comparative efficacy and safety trial between polyherbal formulation WH-1 and FAS-3 kit and Fluconazole in female patients with vaginosis / vaginitis. Journal of Research and Education in Indian Medicine, 0 (0), -.