Clinical study on White Free Capsule in White discharge

Phase 2/3

Completed

Conditions: Other specified noninflammatory disorders of vagina. Ayurveda Condition: Shvetapradar,

Brief Summary: Itwas an open labeled, single center, non-comparative, interventional,prospective, clinical study to evaluate efficacy and safety of White-free Capsulein patients suffering from leucorrhoea. The study was conducted at singlesite in India. Subjects were advised to take 2 capsules of White-Free two timesdaily after meals with water for 30 days. The primary objective of the studywas to assess changes in symptoms associated with Leucorrhoea, Vaginaldischarge and nature of discharge. The secondary objectives of the study wereto assess proportion of cases with complete cessation of symptoms of leucorrhoeaover a period of 30 days, requirement of rescue medications (use of antibioticsand other medications, global assessment for overall change by subject andinvestigator at the end of study treatment, vitals and adverse events, tolerabilityof study drug by assessing ADRs on Day 0, Day 10, Day 20 and Day 30.

**Results and Conclusion:**

**Thirty days of treatment with White-free capsule was significantly

effective in relieving leucorrhoea and associated symptoms. White-free

capsule effectively reduced vaginal discharge within one week. White-

free capsule was well tolerated by all the subjects as there were no

adverse reactions reported. Thus, White-free capsule is safe and effective

for the treatment of Leucorrhoea.**

Recruitment & Eligibility

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

1.Suffering from bacterial vaginosis (Purulent discharge with fishy smell) as per Investigatorâ€™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.

Primary Outcome Measures

Name	Time	Method
Changes in symptoms associated with Leucorrhoea, Vaginal discharge and nature of discharge	Day 0, Day 10, Day 20, Day 30

Secondary Outcome Measures

Name	Time	Method
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)

Locations (1): KVTR Ayurvedic College and Hospital, Boradi
🇮🇳
Dhule, MAHARASHTRA, India
KVTR Ayurvedic College and Hospital, Boradi
🇮🇳Dhule, MAHARASHTRA, India
Dr Rahul R Kamde
Principal investigator
9422815205
kamderahul77@gmail.com