[The Indian Practitioner (2001): (54), 9, 645-649] Evaluation of the Efficacy of V-Gel in Vaginitis and Cervicitis Ranjana, M.D. (Ay.), Lecturer, and Misra, D.N. M.D. (Ay.), Reader and Head, Department of Prasuti, Stree and Balroga, State Ayurvedic College and Hospital, Lucknow, Uttar Pradesh, India. [Communications to: Dr. Kala S. Kulkarni, MD, Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India] ABSTRACT An open clinical trial was conducted in twenty six women suffering from vaginitis and cervicitis. After confirming the clinical and microbiological diagnosis, all the females were given V-Gel, which was recommended to be applied topically on the vagina and cervix, twice daily for 15 days. The soreness of cervix, pruritus, inflammation of vulva, vaginal discharge was significantly reduced within two weeks of drug treatment. Foul odour of the vaginal discharge disappeared significantly. Majority of patients showed microbiological cure after treatment with V-Gel. Eighty three per cent of patients had partial relief within one week and 60% patients had complete relief at two weeks. Thus, V-Gel was found to be clinically effective formulation for the treatment of vaginitis and cervicitis. Key words: Vaginitis; cervicitis; V-Gel; vaginal infections INTRODUCTION Inflammatory conditions of the vagina and associated organs are the most common disorders in gynaecological practice to produce morbidity, manifesting as vaginal discharge and local discomfort. These form a major part of the routine consultation offered in the general gynaecological outpatient department. The vaginal secretion is mainly composed of cervical and endometrial secretions. During the reproductive age, its amount varies with the physiological state of the body. It is maximum before menstruation, early puerperium, after abortion and during ovulation. Apart from these physiological conditions, the discharge is usually not thick enough to soil the under clothing. Thus, excessive discharge with symptoms of local discomfort should raise the possibility for some underlying disease process. The aetiology for these symptoms may be varied with a number of infective and noninfective causes. The vagina usually remains resistant to infections because of its thick stratified squamous epithelium and acidic ph. However, during excessive secretion, this barrier weakens because of the alkaline nature of the secretions, which makes the vaginal epithelium susceptible to infections such as Trichomoniasis, Moniliasis, protozoal or fungal infections or a variety of mixed pathogens like Staphylococci, Streptococci, E. coli and
Gonococci. Oestrogen hormone is largely responsible for the maintenance of normal vaginal health and low levels of oestrogen in girls before menarche and postmenopausal period, lead to vaginitis. Vaginitis is often secondary to the inflammation and infection of the cervix in chronic cervicitis, cervical erosion and the cervical tears which occur during childbirth. The use of pessaries into the vagina containing anti-fungal, anti-bacterial, anti-protozoal drugs are the treatment of choice resulting in quick relief, but often followed by relapses in the early stages. The formulation, V-Gel containing multiple herbs, provides total care by producing antisepsis, decongestant, immunomodulatory and anti-inflammatory properties which helps to promote healing. The efficacy of this vaginal gel formulation is studied for effective relief in vaginitis and cervicitis. MATERIAL AND METHODS An open clinical trial was conducted in the department of Prasuti, Stree and Balroga, State Ayurvedic College and Hospital, Lucknow. Thirty six patients were registered for the clinical trial; six patients were withdrawn due to their irregular visits to the outpatient department. The majority of patients were of the reproductive age group who presented with symptoms of pruritus in the genital region, white discharge per vaginum and other related symptoms such as backache, loss of appetite, muscle cramps and general weakness. All the patients were subjected to complete systemic and local examination to confirm the clinical diagnosis of vaginitis. Microscopic examinations were conducted under low power in wet preparation for the presence of pus cells, epithelial cells, presence of Trichomonas vaginalis and other organisms to confirm the aetiological diagnosis. After preliminary screening, all these patients were recommended local application of V-Gel at a dose of 2 gm twice daily for 14 days and advised to come for follow-up on the 7 th and 14 th day. RESULTS In the present clinical trial 76.66% of the patients were in the reproductive age, 16.66% in the pre-menopausal age, 3.33% in the menopausal age and 3.33% in the pre-pubertal age (Table 1). Hygiene and disease manifestations were connected 80% of the patients had poor hygienic conditions and only 20% of the patients had average hygienic conditions (Table 2). Table 1: Categorisation of patients Category No. of cases Percentage Reproductive age 23 76.66 Premenopausal 5 16.66 Menopausal 1 3.33 Pre-puberty 1 3.33 Table 2: Relationship of general hygiene in patients Hygienic condition No. of cases % Poor 24 80 Average 6 20
In relation to parity, most of the patients (86.66%) were multiparous, 6.66% patients had primary sterility and 6.66% patients were nulliparous (Table 3). In relation to the clinical signs and symptoms, 60% of patients had soreness, 76.66% had itching and all 100% had vaginal discharge before the initiation of the trial. On local examination, inflamed vulva was found in 36.66%, scratch marks in 30%, abnormal vaginal discharge in 100% and foul odour in 90% cases (Table 4). The main causative factors for vaginitis and cervicitis were non-specific Gram-positive and Gram-negative bacilli (43.33% & 53.33%, respectively), E. coli was found in 6.66% and no organisms were found in 16.66% patients (Table 5). In non-specific Gram-positive and Gram-negative positive patients, pus cells were found in 30% of the cases. On day 14, only 4 cases showed a few pus cells while the remaining 5 cases had no pus cells (Table 6). This is evidence of control of vaginal infection after treatment with V-Gel. The clinical response to V-Gel is shown in (Table 7). On the day of registration, soreness was found in 60% of the patients, on day 7 it had reduced to 36.66% while on day 14, it remained only in 3.33% of patients. Itching on day zero, was 76.66%, on day 7, 53.33% and on day 14, it remained only in 10% of the cases. Inflammed vulva, on day zero, was found in 36.66% of the cases, whereas on day 7, it was found in 6.66% and on day 14, it totally disappeared. Abnormal vaginal discharge was found initially in 100% of the cases, on day 7 it was in 90.66% and on day 14 it was reduced to 66.66%. Foul odour on day zero was 90%, on day 7, 63.33% while on day 14, it was in 16.66%. Table 3: Parity and its association with Parity No. of cases % Multiparous 26 86.66 Nulliparous 2 6.66 Primary infertility 2 6.66 Table 4: Clinical symptoms and signs in Symptom Sign No. % Soreness 18 60 Itching 23 76.66 Discharge 30 100 Inflammed vulva 11 36.66 Scratch mark 9 30 Abnormal Vaginal discharge 30 100 Foul odour 27 90 Table 5: Microbiological spectrum in No. % Trichomonas vaginalis Nil 0 E. coli 2 6.66 Gram positive bacilli 13 43.33 Gram negative bacilli 16 53.33 Microscopically negative 5 16.66 Table 6: Presence of pus cells in patients of Pus cell Initial finding Day 14 Total no. 9 30 - - - - 4 13.33 Prior to the treatment, Gram-positive bacilli were present in 43.33% of patients, while on day 14 it was in 6.66% of patients (Table 8).
Out of thirty patients, 60% of patients had complete relief on day 14. Partial response was found on day 7 in 83.33% of patients. In spite of treatment, 5 patients (16.66%) had persistence of symptoms on day 7 and 1 patient (3.33%) on day 14 (Table 9). This open clinical trial suggested that V-Gel was effective in relieving the symptoms of vaginitis and cervicitis in a significant number of patients. DISCUSSION Vaginitis is a polymicrobial infection, therefore, the use of combination drug therapy is always beneficial. Vaginitis may be aggravated during pregnancy, and while using oral contraceptive and antibiotic therapy 1. The Himalaya Drug Company has formulated a polyherbal compound, V-Gel, having multiple herbal constituents. Most of these constituents have antiinflammatory, antimicrobial, analgesic, cooling and soothing effects on the mucosa and also known to decrease the abnormal vaginal secretions. Table 7: Symptomatic response to V-Gel in Symptom Sign Day Zero Day 7 Day 14 No. % No. % No. % Soreness 18 60 11 36.66 1 3.33 Itching 23 76.66 16 53.33 3 10 Discharge 30 100 30 100 9 30 Inflamed vulva Scratch marks Abnormal vaginal discharge 11 36.66 2 6.66 1 3.33 9 30 2 6.66 Nil 0 30 100 29 96.66 20 66.6 6 Foul odour 27 90 19 63.33 5 16.6 6 Trichomonas vaginalis Table 8: Microbiological Response of V-Gel Zero day Day 7 Day 14 No. % No. % No. % Nil 0 - - 2 6.66 E. coli 2 6.66 - - Nil 0 Gram ve bacilli 13 43.33 - - 5 16.66 Gram ve bacilli 16 53.33 - - 9 30 Microscopically ve 5 16.66 - - - - The alkaloid of Berberis aristata Table 9: Outcome of V-Gel treatment has significant anti-inflammatory Day 7 Day 14 effect in acute, subacute and Response chronic inflammation 2 No. % No. %. The active Complete Nil 0 18 60 principle of Neem possesses Partial 25 83.33 11 36.66 antibacterial, antiviral and antifungal properties 3-4 Persistence of symptoms 5 16.66 1 3.33. Vitex negundo leaves have antibacterial properties effective against E. coli and is commonly used in excessive vaginal discharge. It also promotes healing in inflammatory conditions 5. Lawsonia leaves are also effective as an antibacterial and is used to decrease vaginal discharge and also have a cooling effect 6. Permalia has got demulcent properties, which helps in healing. Elettaria cardamomum is a good anti-inflammatory 7. Cedrous deodara oil has anti-inflammatory property and is a good antifungal agent 8. Oil of Tajetes erectus leaves has good antifungal properties. Rosa centifolia flower has anti-inflammatory, healing and
deodorant properties. Boerhaavia diffusa also has anti-inflammatory action and decreases the vaginal discharge. The fruits of Anthrum sowa have anti-inflammatory, analgesics and styptic properties. The whole plant of Nelumbo nucifera has cooling effect and styptic properties. CONCLUSION It was found that V-Gel was effective in the management of Vaginitis, Vulvitis, Cervicitis and associated symptoms. In our opinion V-Gel formulated by The Himalaya Drug Company has a definite role in the relief of symptoms of itching, burning, discharge and foul odour in vaginitis and cervicitis. ACKNOWLEDGEMENT I consider myself extremely fortunate to conduct this drug trial in our State Ayurvedic College and Hospital. I pay thanks to Dr. Renu Gupta (Research Assistant) who has helped in preparing the microscopic films, case history, etc. It was not possible to complete this project without the help of Principal/Superintendent, State Ayurvedic College and Hospital and Dr. Shail Kumari, Lecturer in Dept. of Prasuti, Stree and Balroga, State Ayurvedic College, Lucknow. All my professional friends and staff who worked with me really deserve more than what I can express for their help and co-operation. I am also thankful to Dr. S.K. Mitra, Executive Director, Technical Services, R&D Centre, The Himalaya Drug Company, Bangalore, for his kind co-operation, financial assistance and drug supply. REFERENCES 1. Sobel, J.D. Vulvovaginal Candidiasis In: Holmes K.K. et al. Editors Sexually Transmitted Diseases ED-2, New York: Mcgraw Hill, 1990;515 2. Pandey, G.S (Ed.) Bhavaprakasa Nighantu, 9 th Edn. 1993;119. 3. Nadkarni, K.M. Indian Materia Medica, 1996;1:784. 4. Satyavathi G.V., Raina, M.K., Sharma, M. Medicinal Plants of India, 1 Edn. New Delhi: Published by Indian Council of Medical Research, 1976;1:112. 5. Pandey, G.S. (ed.) Bhavaprakasa Nighantu, 9 th Edn. 1993;344. 6. Nadkarni, K.M. Indian Materia Medica, 1996;1:730. 7. Zuhain, H., Sayehm B., Ameen, H.A., Shhora, H. Pharmacological Studies of Cardamon oil in animals. Pharmacological Res. 1996;34(1-2): 79, 82. 8. Chaddha, Y.R. The Wealth of India, Revised Edn, New Delhi, Published by Council of Scientific and Industrial Research, 1992;3:408.