Effectiveness of a Herbal Vaginal Tablet Containing Oak Gall and Ajwain on Vaginitis: A Randomized, Double-blind Pilot Study

Document Type : Original paper

Authors

1 Department of Persian Medicine, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.

2 Hospital Clinic-Maternitat, School of Medicine, University of Barcelona, Barcelona, Spain.

3 Traditional Medicine and Materia Medica Research Center and Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

4 Department of Traditional Medicine, School of Traditional Medicine, Qom University of Medical Sciences, Qom, Iran.

5 Department of Traditional Pharmacy, Faculty of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.

6 Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences. Tehran, Iran.

Abstract

Background and objectives: Vaginitis is one of the most common diseases in women. Oak gall and ajwain have been used in traditional Persian medicine for treatment of vaginitis. The purpose of this study was to formulate a vaginal preparation containing oak gall and ajwain and evaluate its effectiveness on the recovery and recurrence of vaginitis. Methods: The present pilot study is a randomized, double-blind clinical trial performed on 24 women with mixed vaginitis, including bacterial vaginitis and trichomoniasis in a gynecology center. Subjects were divided into two groups receiving herbal vaginal tablets or metronidazole vaginal tablets for 7 days. The vaginal tablets were prepared using dried extract of oak gall and essential oil from ajwain by direct compression method. Clinical signs and laboratory tests were assessed after treatment. The symptoms were evaluated on day 10, and also 4 and 12 weeks after intervention. Results: There was a statistically significant difference in sexual function, and characteristics of secretions including amount, pH, odor, leukocyte count and parasite content in both groups of herbal (oak gall and ajwain) and metronidazole vaginal tablets before and after treatment (p<0.05). The group receiving herbal vaginal tablets showed significantly reduced secretion at follow-up on day 10 and after 4 weeks (p<0.05).
Conclusion: In our pilot study, herbal vaginal tablets containing oak gall and ajwain were as effective as metronidazole vaginal tablet. The results provide a good basis for future confirmatory tests.
 

Keywords

Main Subjects


  •  

    • Brown L. Pathology of the vulva and vagina. London: Springer, 2013.
    • Amir Aliakbari S, Tafazoli H. Bacterial vaginosis and probiotics. Adv Nurs Midwifery. 2011; 21(74): 48–53.
    • Hacker N, Gambone J, Hobel C. Essentials of obstetrics and gynaecology. 6th Elsevier, 2015.
    • Rabiei M, Akbari H, Naseri M, Bekhradi R, Nikzad M, Torkestani F. Comparison of clinical response to Zataria multiflora vaginal cream and boric acid in patients with recurrent vulvovaginal candidiasis. Danesh Med. 2012; 20(5): 35–42.
    • Levi A, Harigopal M, Hui P, Schofield K, Chhieng D. Comparison of affirm VPIII and Papanicolaou tests in the detection of infectious vaginitis. Am J Clin Pathol. 2011; 135(3): 442–447.
    • Berek J. Berek & Novak’s gynecology. 15th Lippincott: Williams & Wilkins, 2011.
    • Mylonas I, Bergauer F. Diagnosis of vaginal discharge by wet mount microscopy: a simple and underrated method. Obstet Gynecol Surv. 2011; 66(6): 359–368.
    • Mehriardestani M, Aliahmadi A, Toliat T, Rahimi R. Medicinal plants and their isolated compounds showing anti-Trichomonas vaginalis- activity. Biomed Pharmacother. 2017; 88: 885–893.
    • Sarhadinejad Z, Tajadini H, Tansaz M, Bahrampour A, Sarhady Nejad Z, Ansari M, Sharififar F, Iranpoor M, Salari Z. Comparing the effect of dill seed vaginal cream, with a persian traditional base, and 1% clotrimazole vaginal cream on vulvovaginal candidiasis: a double-blind, randomized clinical trial. Iran Red Crescent Med J. 2018; 20(10): 1–10.
    • Tansaz M, Memarzadehzavareh H, Qaraaty M, Eftekhar T, Tabarrai M, Kamalinejad M. Menorrhagia management in Iranian traditional medicine. J Evid Based Complement Altern Med. 2016; 21(1): 71–76.
    • Amin G. Popular medicinal plants of Iran. 1st Tehran: Tehran University of Medical Sciences, 1991.
    • Farzaei M, Zangeneh M, Goodarzi N, Zangeneh A. Stereological assessment of nephroprotective effects of Trachyspermum ammi essential oil against carbon tetrachloride-induced nephrotoxicity in mice. Int J Morphol. 2018; 36(2): 750–757.
    • Aghili Khorasani M. Makhzan-al-advia. 2nd Tehran: Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, 2010.
    • John M, Esienumoh E, Nsemo A, Yagba Traditional reproductive health practices among women in South Nigeria. Int J Nur Care. 2017; 1(2): 1–6.
    • Zarshenas M, Moein M, Samani S, Petramfar P. An overview on ajwain (Trachyspermum ammi) pharmacological effects; modern and traditional. J Nat Remedies. 2013; 14(1): 98–105.
    • MehriArdestani M, Aliahmadi A, Toliat T, Dalimi A, Momeni Z, Rahimi R. Evaluation of antimicrobial activity of Trachyspermum ammi (L.) sprague essential oil and its active constituent, thymol, against vaginal pathogens. Trad Integr Med. 2020; 5(2): 49–58.
    • Panahi P, Jamzad Z, Pourmajidian M, Fallah A, Pourhashemi M. Foliar epidermis morphology in Quercus (subgenus Quercus, section Quercus) in Iran. Acta Bot Croat. 2012; 71(1): 95–113.
    • Ibn Al-Nafis A. Al-shamel fi sanaat Al-tebieh. 1st Tehran: Central Library of University of Tehran Publications, 2013.
    • Mehri Ardestani M, Aliahmadi A, Toliat T, Dalimi A, Momeni Z, Rahimi R. Antimicrobial activity of Quercus infectoria gall and its active constituent, gallic acid, against vaginal pathogens. Trad Integr Med. 2019; 4(1): 12–21.
    • Vazirian M, Khanavi M, Amanzadeh Y, Hajimehdipoor H. Quantification of gallic acidin fruits of three medicinal plants. Iran J Pharm Res. 2011; 10(2): 233–236.
    • The United States Pharmacopeial Convention. United States Pharmacopeia National Formulary (USP 37–NF 32). Rockville: United States Pharmacopeial Convention, 2012.
    • Sohrabvand F, Nazem E, Tansaz M, Keshavarz M, Hashem Dabaghian F, Nikbakht Nasrabady A, Ghooshehghir S, Bioos S, Mokaberinejad R. Investigation of the personal and uterine humor in infertile women referred to Vali-e-Asr hospital of Tehran, Iran in 2012. Iran J Obstet Gynecol 2014; 17(94): 10–19.
    • Fakhri A, Mohammadi Zeidi I, Pakpour Haji Agha A, Morshedi H, Mohammad Jafari R, Ghalambor Dezfooli F. Psychometric properties of Iranian version of female sexual function index. Jundishapur J Sci Med. 2011; 10(4): 345–354.
    • Masoudi M, Miraj S, Rafieian Kopaei M. Comparison of the effects of Myrtus communis, Berberis vulgaris and metronidazole vaginal gel alone for the treatment of bacterial vaginosis. J Clin Diagnostic Res. 2016; 10(3): 4–7.
    • Achondou A, Fumoloh F, Aseneck A, Awah A, Utokoro A. Prevalence of bacterial vaginosis among sexually active women attending the CDC Central Clinic Tiko, Southwest Region, Cameroon.  Afr J Infect Dis. 2016; 10(2): 96–101.
    • Baery N, Ghasemi Nejad A, Amin M, Mahroozade S, Mokaberinejad R, Bioos S, Anushiravani M, Aliasl J, Karimi Darmiyan M, Amin G. Effect of vaginal suppository on bacterial vaginitis based on Persian medicine (Iranian traditional medicine): a randomised double blind clinical study. J Obs Gyn. 2018; 38(8): 1110–1114.
    • Ahmad WA, Hasan AZ, Abdullah AN, Tarannum TA. Efficacy of a combination of Unani drugs in patients of Trichomonal vaginitis. Indian J Tradit Knowl. 2011; 10(4): 727–730.
    • Jahić M, Nurkić M, Fatusić Z. Association of the pH change of vaginal environment in bacterial vaginosis with presence of Enterococcus faecalis in vagina. Med Arh. 2006; 60(6): 364–
    • Jafarzadeh H, Ivanbagha R, Hasanzadeh D, Sorush Barhaghi M, Sayyah Melli M, Asghar M. Comparsion of the effect of Lactobacillus acidophilus suppository and metronidazol vaginal tablet on bacterial vaginosis. Hayat. 2011; 17(3): 6–14.
    • Khan M. Clinical study of "Sailanur rahem" and it’s management with Unani formulation. Mahire Tib (M.D. Unani) thesis. Department of "Ilmul Qabalat wa Amraze Niswan". National Institue of Unani Medicine, Rajiv Gandhi University, Bangalore, 2007.
    • Simoes J, Bahamondes L, Camargo R, Alves V, Zaneveld L, Waller D, Schwartz J, Callahan MM, Mauck Ck. A pilot clinical trial comparing an acid‐buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis. Br J Clin Pharmacol. 2006; 61(2): 211–217.
    • Marcone V, Calzolari E, Bertini M. Effectiveness of vaginal administration of Lactobacillus rhamnosus following conventional metronidazole therapy: how to lower the rate of bacterial vaginosis recurrences. New Microbiol. 2008; 31(3): 429–433.
    • Bradshaw C, Walker J, Fairley C, Chen M, Tabrizi S, Donovan B, Kaldor J, Mcnamee K, Urban E. Prevalent and incident bacterial vaginosis are associated with sexual and contraceptive behaviours in young Australian women. PLoS One. 2013; 8(3): 1–8.
    • Shirooye P, Yavari M, Naiemi S, Bahman M, Meyari A, Memarzadeh Zavareh H, Tansaz M, Bioos S, Nabi Meybodi R. Pathophysiology of vaginal discharge from Iranian Traditional Medicine (ITM) point of view compared with common medicine. Iran J Obstet Gynecol Infertil. 2016; 19(37): 75–84.
    • Meyari A, Tansaz M, Yavari M, Bahman M, Memarzadeh Zavareh H, Nabi Meybodi R, Biglerkhani M, Naeimi S. Nutritional recommendations for patients with uterine discharge in Iranian Traditional Medicine. Iran J Obstet Gynecol Infertil. 2017; 20: 68–77.
    • Yavari M, Shirooye P, Nabi Meybodi R, Meyari A, Bahman M, Memarzadeh Zavareh H, Tansaz M. Treatment approach to leucorrhea in traditional Iranian medicine and conventional medicine. Iran J Obstet Gynecol Infertil. 2016; 19(30): 26–36.
    • Sarwat S, Ahmad N. Screening of potential medicinal plants from district Sawat specific for controlling women diseases. Pak J Bot. 2012; 44(4): 1193–1198.
    • Basri DF, Tan LS, Shafiei Z, Zin NM. In vitro antibacterial activity of galls of Quercus infectoria Olivier against oral pathogens. Evid Based Complement Altern Med. 2012; Article ID 632796.
    • Kaur G, Hamid H, Ali A, Alam M, Athar MO. Antiinflammatory evaluation of alcoholic extract of galls of Quercus infectoria. J Ethnopharmacol. 2004; 90(2-3): 285–292.
    • Jalalpure S, Patil M, Alagawadi K. Wound healing activity of the galls of Quercus infectoria J Nat Remedies. 2002; 2(1): 54–58.
    • Kaur G, Arora D. In vitro antibacterial activity of three plants belonging to the family Umbelliferae. Int J Antimicrob. 2008; 31(4): 393–395.
    • Shrestha SA, Kaushik VS, Eshwarappa RSB, Subaramaihha SR, Ramanna LM, Lakkappa DB. Pharmacognostic studies of insect gall of Quercus infectoria Olivier (Fagaceae). Asian Pac J Trop Biomed. 2014; 4(1): 35–39.
    • Safiaghdam H, Oveissi V, Bahramsoltani R, Farzaei M, Rahimi R. Medicinal plants for gingivitis: a review of clinical trials. Iran J Basic Med Sci. 2018; 21(10): 978–991.
    • Lodhi G, Singh HK, Pant KK, Rao CV, Hussain Z. Hepatoprotective effects of Quercus infectoria gall extract against carbon tetrachloride treated liver injury in rats. Int J Applied Res Nat Product. 2012; 5(3): 17–22.
    • Kaur G, Athar M, Alam MS. Quercus infectoria galls possess antioxidant activity and abrogates oxidative stress-induced functional alterations in murine macrophages. Chem Biol Interac. 2008; 171(3): 272–282.