Health Condition 1: N898- Other specified noninflammatory disorders of vagina
Conditions
Interventions
Intervention1: Sange Jarahat ((Hydrated magnesium silicate) 6 g
Mazu Sabz (Galls of Quercus Infectoria Oliv)- 6 g
Nukhood Biryan (seeds of Cicer arietinum L.) 6 g
Nabaat-e-safeed (Saccharum offi
Sponsors
National Institute Of Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Married women in reproductive aged (18-45 years). Participants who fulfil at least three out of the four Amsel criteria (homogenous vaginal discharge, vaginal PH more than 4.5, positive whiff or amine test and presence of clue cells) to diagnose bacterial vaginosis. Participants with positive Gram stain for BV by Nugent score four.
Exclusion criteria
Exclusion criteria: Presence of abnormal uterine bleeding, ongoing menstruation, frequent vaginal douching, alcohol consumption. Pregnancy, breastfeeding, use of oral contraceptives or intrauterine devices, or having multiple sexual partners. Existing medical conditions such as liver, kidney, or central nervous system disorders, blood disorders, uncontrolled hypertension more than 140/90 mmHg, diagnosed sexually transmitted infections other than BV. Known allergy or hypersensitivity to metronidazole. Inability or unwillingness to avoid alcohol consumption. Use of other antimicrobial agents (oral or topical), or having completed a recent course of antibiotics or antifungals within the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be clinical cure 1) Normal vaginal discharge, 2) negative 10% potassium hydroxide whiff test, and 3) clue cells less than 20% of total epithelial cells on microscopic examination of the vaginal wet mount using saline after treatment.Timepoint: day 8, 14, 21 and day 30 (three follow-ups without treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| : It includes Microbiologic cure, defined as a Nugent score of 0 3 Therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure after treatment. Vaginal symptom scale (VSS). Patients Global Assessment of Tolerability to Therapy (PGATT) and Patients Global Assessment of Response to Therapy (PGART) Timepoint: Baseline and day 14 | — |
Countries
India
Contacts
Public ContactArshiya Sultana
National Institute of Unani Medicine
Outcome results
None listed