Health Condition 1: N760- Acute vaginitis
Conditions
Interventions
Intervention1: FDC of CLINDAMYCIN 100 mg and Clotrimazole 100 mg: HS for 7 days
Control Intervention1: Clotrimazole 100mg: HS for 7 days
Sponsors
Aristo Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
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). 3. 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 ââ?¬â?? 60% sensitivity) of vaginal discharge. ââ?¬â?? 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 (Amselââ?¬•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. 4. 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). 5. Capable of giving written informed consent. 6. Agree to no intercourse for 8 days from the day of start of treatment.
Exclusion criteria
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 patientââ?¬•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. 11. Inability to keep return appointments 12. Presence of intrauterine device. 13. Patients who do not agree to stop use of any other antibacterial, antifungal or anti protozoal drug during trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ 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. ââ?¬Â¢ Safety endpoints (adverse events, vital signs). Timepoint: visit 1 visit 2 visit 3 visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ The secondary efficacy endpoints are a) Time to resolution of symptoms. b) Change in lab parameters compared to baseline. (CBC, ESR, LFT(SGPT (ALT), SGOT (AST), S. Bilirubin (TOTAL), S. Bilirubin (DIRECT), RFT (Serum Creatinine, BUN) , urine routine and microscopic and BSL (Random).Timepoint: Visit 1 and Visit 4 | — |
Countries
India
Contacts
Public ContactManisha Banavalikar
Aristo Pharmaceuticals Pvt Ltd
Outcome results
None listed