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.
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.
Salhan
Sudha
S
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
Tripathi
Vrijesh
V
Sehgal
Raman
R
Kumar
Gaurav
G
Talwar
Gursaran P
GP
Chatterjee
Arani
A
D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D007239:Infections / Q000188:drug therapy*; D010570:Pessaries; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D028321:Plant Preparations; D011206:Povidone-Iodine / Q000627:therapeutic use; D011803:Quinine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies; D019522:Vaginal Discharge / Q000188:drug therapy / Q000209:etiology; D014623:Vaginal Diseases / Q000188:drug therapy*
D000890:Anti-Infective Agents; D010936:Plant Extracts; D028321:Plant Preparations; C086286:Praneem; D014622:Vaginal Creams, Foams, and Jellies; D011206:Povidone-Iodine; D011803:Quinine