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.

Full Abstract

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 IotaIota 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.

Author information

Author/s: Salhan, Sudha (S); Tripathi, Vrijesh (V); Sehgal, Raman (R); Kumar, Gaurav (G); Talwar, Gursaran P (GP); Chatterjee, Arani (A);

Affiliation: Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.

Journal and publication information

Publication Type: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Asia-Pacific journal of public health / Asia-Pacific Academic Consortium for Public Health (Asia Pac J Public Health), published in China. (Language: eng)

Reference: 2009-Oct; vol 21 (issue 4) : pp 461-8

Dates: Created 2009/09/28; Completed 2009/11/03;

PMID: 19783561, status: MEDLINE (last retrieval date: 11/3/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adult
Anti-Infective Agents - adverse effects; therapeutic use
Chi-Square Distribution
Female
Humans
Infection - drug therapy
Pessaries
Phytotherapy - adverse effects

Plant Extracts - adverse effects; therapeutic use
Plant Preparations
Povidone-Iodine - therapeutic use
Quinine - adverse effects; therapeutic use
Treatment Outcome
Vaginal Creams, Foams, and Jellies
Vaginal Discharge - drug therapy; etiology
Vaginal Diseases - drug therapy

Associated Chemicals: Anti-Infective Agents (0) ; Plant Extracts (0) ; Plant Preparations (0) ; Praneem (0) ; Vaginal Creams, Foams, and Jellies (0) ; Quinine (130-95-0) ; Povidone-Iodine (25655-41-8)

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