Clinical Trial of Miconazole nitrate 100mg + Neomycin sulphate 20 mg + Tinidazole 500 mg vaginal tablets

Multicentric, open-labeled, randomized, parallel-group, active-controlled phase III clinical trial comparing fixed dose combination of Miconazole Nitrate 100 mg + Neomycin Sulphate 20 mg + Tinidazole 500 mg vaginal tablets with Miconazole Nitrate 100 mg vaginal pessary in patients with vaginitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002446

Enrollment

200

Registered

2012-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Clinically diagnosed vaginitis Health Condition 2: N761- Subacute and chronic vaginitis

Interventions

Intervention1: Vaginal tablet of FDC of Miconazole Nitrate 100 mg + Neomycin Sulphate 20 mg + Tinidazole 500 mg: Dose - One vaginal tablet Duration - 4 consecutive nights mode of admin - Vaginal freq

Eligibility

Inclusion criteria

Inclusion criteria: 1. All the patients with duly filled Informed Consent Forms [ICF]. 2. Female patient above the age of 18 years. 3. Clinically diagnosed vaginitis, presence of any four following seven symptoms: • Vaginal discharge • Itching • Frequent urination • Burning micturition • Irritation • Foul smell of discharge • Dyspareunia 4. Vaginal smear positive for bacteria/ fungal infection/ infestation 5. Patient with negative urine pregnancy test. 6. Patient between 5th to 25th days of menstrual cycle. 7. Female of childbearing age on accepted mode of contraception such as oral contraceptive tablets or Copper-t [CuT]

Exclusion criteria

Exclusion criteria: 1. Known sensitivity to azoles derivatives and amino glycosides. 2. Women who will be the under treatment during the study period for cervical intra epithelial neoplasia or cervical carcinoma. 3. Pregnancy and lactation. 4. Women with gynaecological condition that contraindicated the use of vaginal tablet. 5. Women who have used any other local or systemic antibacterial, antiprotozoal, antifungal agent in the last two weeks. 6. Patients who have been tested positive for HIV-I and HIV-II, HBV and VDRL. 7. Patients using spermicides, diaphragm and oral contraceptives. 8. Patients whose routing urine analysis has unveiled presence of gonococci. [gonococcal infection] 9. Women with metabolic or immunological disorder. 10. Dysfunctional uterine bleeding. 11. Patient consuming alcohol or chronic alcoholic patient. 12. Patients with concomitant disease like Pulmonary Kochâ??s, Bronchial asthma, Diabetes Mellitus, Epilepsy, CCF etc. 13. Patient with concomitant medication which according to the investigator can alter the metabolism and efficacy of the test medication.

Design outcomes

Primary

Measure	Time frame
Cure rate or reduction occurred in symptoms and signs of vaginitisTimepoint: day 4 and day 8	—

Secondary

Measure	Time frame
1. Microbiological evaluation of vaginal smear. 2. Investigator global impression. (Likert scale) Timepoint: day 4 and day 8	—

Countries

India

Contacts

Public ContactDr Mukund Zarapkar

LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.

drzarapkar@lifesan.in912266499154

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026