To assess the Safety and efficacy of clingen vaginal suppositories in patients with mixed vaginal infection

Phase 4

Recruiting

• Conditions: Acute vaginitis,

• Registration Number: CTRI/2018/11/016365
• Lead Sponsor: Aristo Pharmaceuticals Pvt Ltd

Brief Summary

Vaginitisis 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 canresult in vaginitis. This causes lining of vagina to become inflamed. Factorsthat can change the normal balance of vagina include: Use of antibiotics, Changein hormone level due to pregnancy, breastfeeding or menopause, douching, spermicides,sexual intercourse and infection. Treatment will depend on the cause ofvaginitis. Treatment may be either with pill or a cream or a gel that isapplied to vagina. Bacterial vaginitis is caused by overgrowth of bacteria thatoccur naturally in vagina main symptom is increased discharge with strong fishyodour the discharge usually is thin and dark or dull gray but may have agreenish color. Itching is not common but may be present if there is lot ofdischarge. Several different antibiotics can be used to treat Bacterial Vaginosis.One of them is Clindamycin.

Ayeast infection is caused by fungus called Candida. It is found in smallnumbers in the normal vagina. However when the balance of the bacteria andyeast in the vagina is adhered, the yeast may overgrow and causes symptoms. Useof some type of antibiotics increases your risk of yeast infection. Theantibiotics kill natural vaginal bacteria, which keeps yeast in check. Theyeast can then overgrow. Most common symptoms of yeast infection are itchingand burning of the area outside the vagina called vulva. The vulva may be redand swollen. The vaginal discharge is usually white, lumpy and has no odour.Some women with yeast infection notice an increase or change in discharge. Trichomoniasisis condition caused by microscopic parasite Trichomonas vaginalis. it is spreadthrough sex. Signs may include a yellow gray or green vaginal discharge. Thedischarge may have fishy odour. There may be burning,Irritation, redness and swelling of vulva. Sometimes there is pain duringurination.

Clindamycinis an antibacterial agent, kills bacteria by inhibiting bacterial proteinsynthesis by affecting the process of peptide chain initiation. Clindamycin hasexcellent activity against many anaerobes as well as aerobic gram-positive Cocci.It exhibits anti bacterial activity against most of the organisms that thathave been associated with bacterial5.

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

 Clingen suppositories are availablein India by Aristo Pharmaceuticals forlast 10 years. Periodic safety and efficacy of the fixed dose combination is tobe assessed. Clingen is indicated in mixed vaginal infections includingBacterial Vaginosis, Vaginal Candidiasis, Trichomoniasis; infective leucorrheaand non-specific vaginitis. The aim of the present study is to generate safetyand efficacy data of Clingen suppositories in clinical condition of mixed Vaginitisin 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 dosecombination of Clindamycin (100 mg) and Clotrimazole (100 mg) vaginalsuppositories (Clingen) compared to clotrimazole (100 mg) vaginal suppositoriesin patients with mixed vaginitis.†proposed to be conducted in the Indianpopulation as per the requirement of schedule Y of Drugs & Cosmetic rules 2005, under the NOC of DrugsController General of India (DCGI), for retaining permission of Manufacturing& Marketing of Clingen suppositories in India**.**

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• 1.Females 18 years of age or older.
• 2.Women with regular menstruation and visiting the trial centre from 5th day to 20th day of the cycle or post menopausal women (defined as women with absence of menstruation for at least 1 year from the date of screening.), or women with surgical menopause (oophorectomy, hysterectomy).
• Female subjects screened positive for mixed vaginal infection based on two or more of the following microscopic findings 1)Yeasts or pseudohyphae on wet preparation (40 – 60% sensitivity) of vaginal discharge.
• – and/or Yeasts or pseudohyphae on Gram stain (up to 65% sensitivity) of vaginal discharge 2)Direct observation of the organism (T.
• vaginalis) by a wet smear (normal saline) or acridine orange stained slide from the posterior vaginal fornix (sensitivity 40-70% cases).
• 3)A Gram stain slide with Nugent score more than equal to 4.
• And/or (Amsel’s Diagnostic Criteria for Bacterial Vaginosis) a) Off-white, thin, homogeneous discharge with little if any inflammation.
• b) pH of vaginal fluid greater than 4.5, using pH paper that measures from 4.0 to 6.0 c) Positive whiff test for amine odour after addition of 10% KOH.
• d) More than or equal to 20% Clue cells of the total epithelial cells on microscopic examination of the saline/wet mount.
• Subjects who agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, Spermicides, tampons, and diaphragms).
• Capable of giving written informed consent.
• Agree to no intercourse for 8 days from the day of start of treatment.

Exclusion Criteria

• 1.Pregnant or lactating women.
• 2.Patients receiving neuromuscular blocking agents.
• 3.Patients having history of hypersensitivity to Clindamycin or Clotrimazole.
• 4.Patients with history of regional enteritis, ulcerative colitis, pseudo-membranous colitis or history of antibiotic associated colitis.
• 5.Women receiving any antibiotic treatment 14 days prior to enrolment.
• 6.Female patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy.
• 7.Patients who have participated in any clinical trial in the past 3 month.
• 8.History of significant cardiovascular disorders or primary or secondary immunodeficiency.
• 9.Any other condition that in the opinion of the Investigator does not justify the patient’s participation in the study.
• 10.Presence of vaginal / vulval ulcer or any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response.
• 13.Patients who do not agree to stop use of any other antibacterial, antifungal or anti protozoal drug during trial period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•The primary efficacy endpoint is the therapeutic cure which requires both clinical cure and pathogen eradication confirmed by microbiological vaginal swab testing and Nugent score of 0-3 at last visit.	visit 1 visit 2 visit 3 visit 4
•Safety endpoints (adverse events, vital signs).	visit 1 visit 2 visit 3 visit 4

Secondary Outcome Measures

Name	Time	Method
•The secondary efficacy endpoints are	a) Time to resolution of symptoms.

Trial Locations

Locations (3)

All india Institute of medical Sciences; 🇮🇳 Delhi, DELHI, India

KMRFS NIKOP HOSPITAL; 🇮🇳 Satara, MAHARASHTRA, India

Terna Speciality Hospital; 🇮🇳 Thane, MAHARASHTRA, India

All india Institute of medical Sciences

🇮🇳Delhi, DELHI, India

DrSunesh Kumar

Principal investigator

Kumar.sunesh@yahoo.com