Health Condition 1: N898- Other specified noninflammatory disorders of vagina
Conditions
Interventions
Intervention1: White Free Capsule: It contains Saraca indica , Asparagus racemosus, Cucurbita pepo, Tinospora cordifolia, Mucuna pruriens, Daemia extnsa, Commiphora mukul, Myristica fragrans, Woodf
Sponsors
Jagat Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women must agree to practice reliable contraception [Intrauterine device (IUD), Tubal sterilization, Vasectomy in male partner. Participants who use a hormonal contraceptive as one of their birth control methods should have the same method for a minimum of 3 months before the first dose of study drug. Acceptable hormonal methods (every hormonal method must be used with a barrier method like a condom, preferably a male condom). Oral contraceptives, Injectable progesterone, Contraceptive vaginal ring. Acceptable barrier methods (should be used with a hormonal method) Male or female condom with or without spermicide] for 30 days following treatment 2. Presenting complaints of moderate grade Vaginal white discharge (moderate discharge, 3-4 days in a week, requires change of undergarments once daily), from last 15 days 3. Not currently menstruating or expected to in the next 4 days 4. Provide written informed consent before initiation of any study procedures and be available for all study visits
Exclusion criteria
Exclusion criteria: 1. Suffering from bacterial vaginosis (Purulent discharge with fishy smell) as per Investigatorââ?¬•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 or autoimmune diseases, uncontrolled diabetes, hypertension, cardiac diseases. 4. Subjects with known history of hepatitis B and/ or C 5. Patients on Oral Contraceptive Pills for last one month 6. Patients with IUCD for last one month 7. Known case of venereal disease 8. History of significant per vaginal bleeding over the last 1 month 9. Prolapsed of uterus 10. Known case of malignancy in the internal genital parts and known case of any malignancy 11. Allergy to any constituent of white free capsule 12. 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 Leucorrhoea, Vaginal discharge and nature of dischargeTimepoint: Day 0, Day 10, Day 20, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of cases with complete cessation of symptoms of leucorrhoea over a period of 30 days 2. Requirement of rescue medications (use of antibiotics and other medications) 3. Global assessment for overall change by subject and investigator 4. Change in vitals and adverse events 5. Assessment of tolerability of study drug by assessing ADRs Timepoint: Day 0, Day 10, Day 20, Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed