Baburao Vikram
Lieue University, IndiaTitle: An Open-Label Pilot Study to Evaluate the Efficacy and Safety of BC Caps For Women With Abnormal Vaginal Discharge Due to Microbial Infections: Case Series
Abstract
Herbal
therapeutics advancement demand in management of abdominal vaginal discharge is
increasing in women as it serves as an important housekeeping function in the
reproductive system. This case series study evaluates the safety and
effectiveness of birth control contraceptives capsules (BC caps) in women
suffering from abnormal vaginal discharge. We conducted an open label
interventional study of 15 female patients with in the age of 18-45 years (mean
33.7 years) with a history of abnormal vaginal discharge. Patients were asked
to administer two BC caps (neem seed oil) capsule of 500 mg manually to vagina
daily at night for 15 days followed by treatment assessment as per each schedule
visit. Primary outcome includes change in microbiological parameters. Secondary
outcomes included monitoring of adverse event (AE) and serious adverse event
(SAE), changes in clinician’s assessment of symptoms and change in Subject’s
global assessment of symptoms. The study showed the 93.33% and 87.5%
improvement in abnormal vaginal discharge and cervical abnormalities.
Microbiological cure rate found was 100% for pathogens. A constant decline was
seen in the mean values of all the associated symptoms. Significant results in
whiff and pH test were observed after treatment. The vaginal discharge was
observed to be clear in 100% of the participants.
Subject’s
assessment of symptoms which were low back pain, vulval itching, general
weakness, foul discharge, and burning sensation were improved. All results were
significant at p value <0.05. The study found that BC caps is highly
effective and safe in a treatment for abnormal vaginal discharge. It also
showed improvements on associated symptoms with minimal to zero side effects.
Keywords: Open
label, Vaginal discharge, Treatment
Biography
Mr. Baburao Vikram has M.S.
(Pharmacology & Toxicology) from NIPER, Mohali. Total 17 years of
experience in the conduct of clinical trial projects, pre-clinical studies,
project management, clinical trial monitoring, design and conduct of real-world
and late phase programs, drug safety, Regulatory support, Toxicology studies,
Cosmetic studies for registration, Medical device technical files for CE
marking, Lead auditor for ISO9001:2015, Internal auditor ISO13485 and PDE
reports author and reviewer.
Organization Location
1309 Coffeen Avenue, STE 1200, Sheridan, Wyoming 82801, USA
Mail us at
Program Enquiry
midwifery@scientexconferences.com
General Queries
contact@scientexconferences.com
Registration Enquiry
finance@scientexconferences.com
neonatalcare@scientexevents.com
Our Social Presence
Call us at
USA :+1 (689) 267 3738