DOI: http://dx.doi.org/10.18203/2320-1770.ijrcog20220918

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

Baburao Vikram, Neetu Rawal, Sunil Gupta

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

Full Text:

PDF

References


Alzohairy MA. Therapeutics Role of Azadirachta indica (Neem) and Their Active Constituents in Diseases Prevention and Treatment. Evid Based Complement Alternat Med. 2016;7382506.

Bahmani M, Saki K, Shahsavari S, Rafieian-Kopaei M, Sepahvand R, Adineh A. Identification of medicinal plants effective in infectious diseases in Urmia, northwest of Iran. Asian Pac J Trop Biomed. 2015;5(10):858-64.

Bates CK, Carroll N, Potter J. The challenging pelvic examination. J Gen Intern Med. 2011;26(6):651-7.

Becker M, Stephen J, Moses S, Washington R, Maclean I, Cheang M, Isac S, Ramesh BM, Alary M, Blanchard J. Etiology and determinants of sexually transmitted infections in Karnataka state, south India. Sex Transm Dis. 2010;37(3):159-64.

Bhowmik D, Yadav J, Tripathi KK, Sampath Kumar KP. Herbal Remedies of Azadirachta indica and its Medicinal Application. J Chem Pharm Res. 2010.

Charonis G, Larsson PG. Use of pH/whiff test or QuickVue Advanced pH and Amines test for the diagnosis of bacterial vaginosis and prevention of postabortion pelvic inflammatory disease. Acta Obstet Gynecol Scand. 2006;85(7):837-43.

Egan ME, Lipsky MS. Diagnosis of vaginitis. Am Fam Physician. 2000;62(5):1095-104.

Mitra A. Evaluation of Contraceptive Properties of Neem Oil-A Prospective Study. Science and Culture. 2018;84(1-2).

Frobenius W, Bogdan C. Diagnostic Value of Vaginal Discharge, Wet Mount and Vaginal pH - An Update on the Basics of Gynecologic Infectiology. Geburtshilfe Frauenheilkd. 2015;75(4):355-66.

García-Closas M, Herrero R, Bratti C, Hildesheim A, Sherman ME, Morera LA, Schiffman M. Epidemiologic determinants of vaginal pH. Am J Obstet Gynecol. 1999;180(5):1060-6.

Giri RP, Gangawane DAK, Giri DSG. Neem the Wonder Herb: A Short Review. Int J Trend in Scientific Res Develop. 2019.

Oxfordshire Clinical Commissioning Group Investigation and Management of Vaginal Discharge in Adult Women. NHS Oxfordshire. 2017. Available at: https://www.google.com/url?sa=t&rct=j&q=& esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi0jqq47732AhWtS2wGHQx9BpAQFnoECAcQAQ&url=https%3A%2F%2Fwww.oxfordshireccg.nhs.uk%2Fprofessional-resources%2Fdocuments %2Fclinical-guidelines%2Fgynaecology%2Finvestig ation-and-management-of-vaginal-discharge-in-adult-women-2016.pdf&usg=AOvVaw1L3Xp-NGerOyXBJDyPuuhF. Accessed on 15 May 2021.

Hemalatha R, Ramalaxmi BA, Swetha E, Balakrishna N, Mastromarino P. Evaluation of vaginal pH for detection of bacterial vaginosis. Indian J Med Res. 2013;138(3):354-9.

Himalaya D. Pengaruh Pemberian Ekstrak Biji Manjakani (Quercus Infectoria Gall) Terhadap Bakteri Vaginosis Dan Candida Penyebab Keputihan (Leukorrhea). J Midwifery. 2017;5(1).

Ilankoon P, Goonewardena CSE, Fernandopulle RC, Perera PPR. Vaginal discharge: women’s health seeking behaviours and cultural practices. Int J Curr Res. 2015;7(6):17473-9.

Institute on Aging. NIA Adverse Event and Serious Adverse Event Guidelines.Available at: https://www. google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwiduaeU8L32AhWlS2wGHQ8MCuAQFnoECAcQAQ&url=https%3A%2F%2Fwww.nia.nih.gov%2Fsites%2Fdefault%2Ffiles%2F2018-09%2Fnia-ae-and-sae-guidelines-2018.pdf&usg=AOvVaw3VsIpZiGm4dp r96pXyK17j. Accessed on 15 May 2021.

Jabeen K, Hanif S, Naz S, Iqbal S. Antifungal Activity of Azadirachta Indica Against Alternaria Solani. Journal of Life Sciences and Technologies, 2013;89-93.

Kelly KG. Tests on Vaginal Discharge. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd Edition, Butterworths, Boston. 1990;833-5.

Khalilzadeh S, Eftekhar T, Rahimi R, Mehriardestani M, Tabarrai M. An Evidence-Based Review of Medicinal Plants Used for the Treatment of Vaginitis by Avicenna in "the Canon of Medicine". Galen Med J. 2019;8:e1270

Owen MK, Clenney TL. Management of vaginitis. Am Fam Physician. 2004;70(11):2125-32.

Mittal A, Kapur S, Garg S, Upadhyay SN, Suri S, Das SK, Gupta S, Talwar GP. Clinical trial with praneem polyherbal cream in patients with abnormal vaginal discharge due to microbial infections. Aust N Z J Obstet Gynaecol. 1995;35(2):190-1.

Moga MA, Bălan A, Anastasiu CV, Dimienescu OG, Neculoiu CD, Gavriș C. An Overview on the Anticancer Activity of Azadirachta indica (Neem) in Gynecological Cancers. Int J Mol Sci. 2018;19(12):3898.

Mullick S, Watson-Jones D, Beksinska M, Mabey D. Sexually transmitted infections in pregnancy: prevalence, impact on pregnancy outcomes, and approach to treatment in developing countries. Sex Transm Infect. 2005;81(4):294-302.

Nasseri A. Vaginal Discharge. Decision Making in Medicine. 2010;576-7.

Neal CM, Kus LH, Eckert LO, Peipert JF. Noncandidal vaginitis: a comprehensive approach to diagnosis and management. Am J Obstet Gynecol. 2020;222(2):114-22.

Patel Y, Gopalan S, Bagga R, Sharma M, Chopra S, Sethi S. A randomized trial comparing a polyherbal pessary (a complementary and alternative medicine) with Ginlac-V pessary (containing clotrimazole, tinidazole and lactobacilli) for treatment of women with symptomatic vaginal discharge. Arch Gynecol Obstet. 2008;278(4):341-7.

Patient education: Vaginal discharge in adult women (Beyond the Basics) - UpToDate. Available at: https://www.uptodate.com/contents/vaginal-discharge-in-adult-women-beyond-the-basics#!. Accessed on 10 February 2021.

Prasad D, Parween S, Kumari K, Singh N. Prevalence, Etiology, and Associated Symptoms of Vaginal Discharge During Pregnancy in Women Seen in a Tertiary Care Hospital in Bihar. Cureus. 2021;13(1):e12700.

Sharma RS, Mathur AK, Chandhiok N, Datey S, Saxena NC, Gopalan S, et al. 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). Transactions of the Royal Society of Tropical Medicine and Hygiene. 2009;103(2):167-72.

Singh K. Integrated Approach to Obstetrics and Gynaecology. In Integrated Approach to Obstetrics and Gynaecology. World Scientific. 2016.

US20130108599A1 - Herbal Vaginal Compositions - Google Patents. Available at: https://patents.google. com/patent/US20130108599A1/en. Accessed on 10 February 2022,

Paladine HL, Desai UA. Vaginitis: Diagnosis and Treatment. Am Fam Physician. 2018;97(5):321-329.

Vaginitis - an overview. ScienceDirect Topics. Available at: https://www.sciencedirect.com/topics/ nursing-and-health-professions/vaginitis. Accessed on 10 February 2022.

Zemouri C, Wi TE, Kiarie J, Seuc A, Mogasale V, Latif A, Broutet N. The Performance of the Vaginal Discharge Syndromic Management in Treating Vaginal and Cervical Infection: A Systematic Review and Meta-Analysis. PLoS One. 2016;11(10):e0163365.