A Clinical Evaluation of Efficacy and Safety of JIVANI Tablets in patients suffering from PID (Leucorrhoea) - An open label, multicentric, interventional, prospective, clinical study
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 3
Study Overview
Brief Summary
It is an open label, multicentric, interventional, prospective, clinical study to evaluate efficacy and safety of JIVANI Tablets in patients suffering from PID (Leucorrhoea). The study will be conducted at 10 to 12 centres in India. Subjects will be asked to take 2 Tablets of JIVANI two times daily after meals with water for 120 days. The primary objective of the study will be to assess changes in symptoms associated with Leucorrhoea. The secondary objectives of the study will be to assess change in tubal blocks as assessed using Hysterosalpingography (HSG), change in vaginal discharge analysis, requirement of rescue medications (use of antibiotics, anti-fungal drugs and other medications), change in dyspareunia, ovulation tracking assessed using ovulation kit, global assessment for overall change by subject and investigator, tolerability of study medications as assessed by participants and investigator, and safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests on Baseline visit, Day 30, Day 60, Day 90 and Day 120
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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
- •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
- •Suffering from severe cases of bacterial vaginosis (Purulent discharge with fishy smell) as per Investigator’s opinion
- •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.
- •Including, but not limited to, ongoing or active infection, active liver, kidney and autoimmune diseases
- •Subjects with uncontrolled diabetes, hypertension and thyroid disease
- •Subjects with hepatitis B, C and HIV Positive, sexually transmitted diseases and active urinary tract infection
- •Subjects with endometriosis and uterine polyps, uterine adenomyosis, symptomatic fibroids, cervical erosion
- •Patients on Oral Contraceptive Pills for last one month
- •Patients with IUCD for last one month
- •History of significant per vaginal bleeding
- •Prolapsed uterus
- •Known case of malignancy in the internal genital parts and known case of any malignancy
- •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.
Investigators
Dr Avinash Deore
Shree Sai Ayurvedic Panchakarma Rugnalaya