Health Condition 1: N739- Female pelvic inflammatory disease, unspecified
Conditions
Interventions
None listed
Sponsors
Gynoveda Femtech Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-pregnant, non-breastfeeding females (married and non-married) presenting complaints of scanty (mild) to moderate grade vaginal white discharge on non-period days (Scanty or mild: small quantity of discharge, 1to 2 days a week, does not require change of undergarments; Moderate: moderate discharge 3 to 4 days a week, requires change of undergarments once daily) for a duration of not more than 180 days 2. Ready to provide written informed consent before initiation of any study procedures and be available for all study visits (Note: Subjects having asymptomatic ovarian cysts, asymptomatic fibroids, irregular periods and PCOD will be included)
Exclusion criteria
Exclusion criteria: 1. Suffering from severe cases of bacterial vaginosis (Purulent discharge with fishy smell) as per Investigator s opinion 2. Women who had used prescribed medications (oral or topical antibiotics including metronidazole, clindamycin, tinidazole etc. Anti-fungal drugs including clotrimazole and ketoconazole etc.) for vaginal complaints in the past 2 weeks. 3. Including, but not limited to, ongoing or active infection, active liver, kidney and autoimmune diseases 4. Subjects with uncontrolled diabetes, hypertension and thyroid disease 5. Subjects with hepatitis B, C and HIV Positive, sexually transmitted diseases and active urinary tract infection 6. Subjects with endometriosis and uterine polyps, uterine adenomyosis, symptomatic fibroids, cervical erosion 7. Patients on Oral Contraceptive Pills for last one month 8. Patients with IUCD for last one month 9. History of significant per vaginal bleeding 10. Prolapsed uterus 11. Known case of malignancy in the internal genital parts and known case of any malignancy 12. Allergy to any constituent of JIVANI Tablet 13. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in symptoms associated with LeucorrhoeaTimepoint: Baseline visit, Day 30, Day 60, Day 90 and Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in tubal blocks as assessed using Hysterosalpingography (HSG) 2. Change in vaginal discharge analysis 3. Requirement of rescue medications (use of antibiotics, anti-fungal drugs and other medications) 4. Change in dyspareunia 5. Ovulation tracking assessed using ovulation kit 6. Global assessment for overall change by subject and investigator 7. Tolerability of study medications as assessed by participants and investigator 8. Safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests Timepoint: Baseline visit, Day 30, Day 60, Day 90 and Day 120 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed