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

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

Efficacy and safety of Neemint capsules in an open label single arm trial of patients with gastrointestinal disorders

 Anti-inflammatory drugs which are commonly used medication in gastrointestinal (GI) disorder worsen symptoms and increasing impend need of better treatment method for the disease. Neemint capsules composed of polyherbal formulation of neem oil and peppermint oil. We conducted this study to assess the efficacy and safety of Neemint capsules in patients with gastrointestinal disorders including irritable bowel syndrome. We conducted an open label clinical study of 15 patients (mean age, 35.2±14.26 years; 86.6% males) with two or more GI symptoms. Patients were given Neemint capsule of 500 mg (350 mg of neem oil+150 mg of peppermint oil) as per each schedule visit. The primary endpoint was change in gastrointestinal symptom rating scale (GSRS-IBS). Secondary endpoints included monitoring of AE and SAE, IBS-quality of life questionnaire and change in subject’s global assessment of symptoms. The overall GSRS score improvement was found to be 64.23%. The IBS-QOL scores also indicated 57.2% increase in the quality of life of the study subject. The mean global assessment of symptoms (diarrhoea, constipation, abdominal pain, nausea vomiting and bloating) score recorded was 0. All results were significant at p&lt;0.05. In this study we found that Neemint capsules is highly efficacious in the treatment of IBS and GI symptoms and it is also well-tolerated and safe in study subjects (n=15) having complaints of IBS and GI disturbances.