Phase II clinical trial with Praneem polyherbal tablets for assessment of their efficacy in symptomatic women with abnormal vaginal discharge (an ICMR task force study).
Abnormal vaginal discharge syndrome (AVDS) is a commonly observed gynaecological complaint for which women seek medical attention. The present study was conducted in six Indian Council of Medical Research centres with Praneem polyherbal tablets (PPT), to determine their efficacy in the treatment of symptomatic women with AVDS. Data are given on 141 subjects investigated. In total, 137 women (97%) reported complete (n=62, 44%) and partial (n=75, 53%) relief from symptoms after use of PPT for seven consecutive days. On speculum examination, 71 (74%) women were confirmed to be cured of AVDS. Microbiological tests could only be conducted microscopically for Trichomonas vaginalis, Candida albicans and bacterial vaginosis. It was observed that all women with T. vaginalis had this infection cured by PPT, and the cure rate was 77% for C. albicans and 68% for bacterial vaginosis. Seventy-eight women (55%) reported a transient burning sensation, mostly on the first 2 d of intake of PPT; however, they continued to use the tablets for the prescribed 7 d. This study lays the basis for an extended Phase II/III clinical trial, preferably randomized and comparing a larger number of women to confirm the safety and efficacy of PPT.
Sharma
R S
RS
Division of Reproductive Health and Nutrition, Indian Council of Medical Research, Ansari Nagar, New Delhi 110029, India. radheyss@gmail.com
Mathur
A K
AK
Chandhiok
N
N
Datey
S
S
Saxena
N C
NC
Gopalan
S
S
Sharma
S
S
Mittal
S
S
Sehgal
R
R
Sumandal
B K
BK
Chanda
A
A
Salvi
V
V
Mutalik
N
N
Coyaji
K J
KJ
Gibsson
A
A
Hazari
K
K
Kalgutkar
S
S
Talwar
G P
GP
D000282:Administration, Intravaginal; D000328:Adult; D026683:Advisory Committees; D000818:Animals; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use; D002177:Candidiasis / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011803:Quinine / Q000009:adverse effects / Q000627:therapeutic use*; D013607:Tablets; D016896:Treatment Outcome; D014247:Trichomonas Vaginitis / Q000188:drug therapy; D019522:Vaginal Discharge / Q000150:complications / Q000188:drug therapy*
D000935:Antifungal Agents; D000981:Antiprotozoal Agents; D010936:Plant Extracts; C086286:Praneem; D013607:Tablets; D011803:Quinine