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Asia-Pacific Journal of Public Health
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A Phase II Randomized Controlled Trial to Evaluate the Safety and Efficacy of Praneem Polyherbal Vaginal Tablets Compared With Betadine Vaginal Pessary in Women With Symptoms of Abnormal Vaginal Discharge

Sudha Salhan, MD

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India

Vrijesh Tripathi, PhD

The University of the West Indies, St. Augustine Campus, Trinidad and Tobago, West Indies

Raman Sehgal, MSc

Panacea Biotec Ltd, New Delhi, India

Gaurav Kumar, MPharm

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India

Gursaran P. Talwar, PhD

Talwar Research Foundation, New Delhi, India

Arani Chatterjee, MBBS, MPhil

Panacea Biotec Ltd, New Delhi, India, aranichatterjee{at}panaceabiotec.com

Abnormal vaginal discharge (AVD) caused by a variety of reproductive tract infections is a widespread syndrome among women in India and in other developing countries. The purpose of this study was to determine whether a polyherbal formulation, Praneem, can be used for the regression of the syndrome. A phase II randomized controlled study was carried out with Praneem polyherbal tablets and Betadine vaginal pessary in 99 women with AVD. The authors found that 92% of women using Praneem were relieved of their symptoms of AVD as against 81.6% women using Betadine. Significant reduction was also seen with both treatments in lower abdominal pain, vaginal itching, and dysuria. Thus, the study indicates the efficacy of Praneem for the treatment of AVD and provides a rationale for planning a further Phase III study on a larger sample size for definitive conclusions.

Key Words: betadine • lower abdominal pain • vaginal itching • dysuria • reproductive tract infection

Asia-Pacific Journal of Public Health, Vol. 21, No. 4, 461-468 (2009)
DOI: 10.1177/1010539509344610
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