Effectiveness of Mrudul intimate gel in the management of Vulvovaginitis

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: N760- Acute vaginitis

• Registration Number: CTRI/2024/07/070990
• Lead Sponsor: Dr Jyoti Birajdar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Female Patients of the age more than 18 yrs and less than 60yrs having complaints of genital pruritus, discharge, inflammation, odour, abrasion.

2.Patients having more than two symptoms.

3.Patients willing to give written informed consent.

4.Patients willing for follow up.

Exclusion Criteria

1.Patients not willing to participate in study

2.Patient’s age less than 18yrs and more than 60yrs

3.Patient suffering from chronic illness like carcinoma

4.Positive history of venereal diseases

5.Patients with history of psychological issues, drug allergy

6.Patient participating in any other research study

7.Women having +ve pregnancy report

8.Patients with uncontrolled HT and DM

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in clinical symptoms - parameters such as itching , discharge, inflammation and pain <br/ ><br>and Improvement in vaginal swab test. <br/ ><br>Timepoint: 1 month (4 weeks)

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the change in the symptoms score before & after intervention. <br/ ><br>2.To assess the change in the biochemical marker ‘Swab Test’(gram stain,10%KOH Mount,Wet Mount,PH) <br/ ><br>3.To observe recurrence of vulvovaginitis after using herbal formulation. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1 month