Vaginitis is an inflammation of the vagina. One third of women will have symptoms of Vaginitis. It affects women’s of all ages but is most common during the reproductive years. A change in balance of the yeast and bacteria that normally live in the vagina can result in vaginitis. This causes lining of vagina to become inflamed. Factors that can change the normal balance of vagina include: Use of antibiotics, Change in hormone level due to pregnancy, breastfeeding or menopause, douching, spermicides, sexual intercourse and infection. Treatment will depend on the cause of vaginitis. Treatment may be either with pill or a cream or a gel that is applied to vagina. Bacterial vaginitis is caused by overgrowth of bacteria that occur naturally in vagina main symptom is increased discharge with strong fishy odour the discharge usually is thin and dark or dull gray but may have a greenish color. Itching is not common but may be present if there is lot of discharge. Several different antibiotics can be used to treat Bacterial Vaginosis. One of them is Clindamycin.

A yeast infection is caused by fungus called Candida. It is found in small numbers in the normal vagina. However when the balance of the bacteria and yeast in the vagina is adhered, the yeast may overgrow and causes symptoms. Use of some type of antibiotics increases your risk of yeast infection. The antibiotics kill natural vaginal bacteria, which keeps yeast in check. The yeast can then overgrow. Most common symptoms of yeast infection are itching and burning of the area outside the vagina called vulva. The vulva may be red and swollen. The vaginal discharge is usually white, lumpy and has no odour. Some women with yeast infection notice an increase or change in discharge. Trichomoniasis is condition caused by microscopic parasite Trichomonas vaginalis. it is spread through sex. Signs may include a yellow gray or green vaginal discharge. The discharge may have fishy odour. There may be burning, Irritation, redness and swelling of vulva. Sometimes there is pain during urination.

Clindamycin is an antibacterial agent, kills bacteria by inhibiting bacterial protein synthesis by affecting the process of peptide chain initiation. Clindamycin has excellent activity against many anaerobes as well as aerobic gram-positive Cocci. It exhibits anti bacterial activity against most of the organisms that that have been associated with bacterial⁵.

Clotrimazole is an imidazole with broad spectrum antifungal action it inhibits fungal cell wall synthesis by inhibiting synthesis of ergosterol, an important component of cell wall which alters the permeability of cell membrane of sensitive fungi and leads to structural and functional impairment of the cyctoplasmic membrane. Clotrimazole has fungicidal action against Candida albicans and trichomonocidal action⁵.

Clingen suppositories are available in India by Aristo Pharmaceuticals for last 10 years. Periodic safety and efficacy of the fixed dose combination is to be assessed. Clingen is indicated in mixed vaginal infections including Bacterial Vaginosis, Vaginal Candidiasis, Trichomoniasis; infective leucorrhea and non-specific vaginitis. The aim of the present study is to generate safety and efficacy data of Clingen suppositories in clinical condition of mixed Vaginitis in Indian population over a single drug treatment of clotrimazole suppositories. This Clinical Study is “A phase IV, double blind, prospective, comparative, randomized, multicentric study to assess safety and efficacy of fixed dose combination of Clindamycin (100 mg) and Clotrimazole (100 mg) vaginal suppositories (Clingen) compared to clotrimazole (100 mg) vaginal suppositories in patients with mixed vaginitis.” proposed to be conducted in the Indian population as per the requirement of schedule Y of Drugs & Cosmetic rules 2005, under the NOC of Drugs Controller General of India (DCGI), for retaining permission of Manufacturing & Marketing of Clingen suppositories  in India.