A polyherbal vaginal pessary with spermicidal and antimicrobial action: evaluation of its safety.
A polyherbal vaginal pessary (Praneem) has been formulated that has antimicrobial properties against genital pathogens in addition to spermicidal action. Thus, it has dual potential as a barrier method for contraception and for providing protection against some sexually transmitted infections. The present study reports the findings of a multicentre trial that was conducted to evaluate the safety of this product. Trials were carried out in 23 women in three centres in India: the Postgraduate Institute of Medical Education and Research, Chandigarh; Safdarjang Hospital, New Delhi; and Kamla Nehru Memorial Hospital, Allahabad. Thorough clinical and pelvic examinations were carried out as well as cervical cytology, blood biochemistry and haematology before and after use of the polyherbal pessary intravaginally once daily for 7 consecutive days. No toxicity was observed on clinical examination or by laboratory investigations. Daily intravaginal use of this pessary for 7 days had no adverse effects on cervical cytology or on metabolic and organ functions.
Bagga
R
R
Department of Obstetrics & Gynaecology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. rashmibagga@gmail.com
Raghuvanshi
P
P
Gopalan
S
S
Das
S K
SK
Baweja
R
R
Suri
S
S
Malhotra
D
D
Khare
S
S
Talwar
G P
GP
D000282:Administration, Intravaginal; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D010570:Pessaries; D008517:Phytotherapy / Q000009:adverse effects*; D010936:Plant Extracts / Q000008:administration & dosage*; D011803:Quinine / Q000008:administration & dosage*; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D013089:Spermatocidal Agents / Q000008:administration & dosage / Q000009:adverse effects*; D014626:Vaginal Smears
D000890:Anti-Infective Agents; D004338:Drug Combinations; D010936:Plant Extracts; C086286:Praneem; D013089:Spermatocidal Agents; D011803:Quinine