A CLINICAL TRIAL ON AYURVEDIC THEREPY IN VAGINAL WHITE DISCHARGE.
- Conditions
- Health Condition 1: N898- Other specified noninflammatory disorders of vagina
- Registration Number
- CTRI/2021/04/032891
- Lead Sponsor
- ational Institute of Ayurveda Jaipur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Married women aged between 18 years to 40 years with
regular menstrual cycle.
2. Presence of 3 out of 4 Amselâ??s diagnostic criteria for
Bacterial Vaginosis:
Off white (milky or grey), thin, homogeneous, adherent
vaginal discharge, with minimal or absent pruritis.
Vaginal pH > 4.5
Positive â??whiff testâ?? (fishy odor of the vaginal discharge with
the addition of a drop of 10% KOH).
Presence of clue cells >=20% of the total epithelial cells on
microscopic examination of the saline wet mount.
3. Patient agrees to refrain from use of douches, oral or intra vaginal antibiotics or antifungal agents or lubricants during the
entire study period.
4. Patient agrees to use condom/ abstinence during the
treatment period.
5. Patient willing and agrees to participate for three months and
signs informed consent.
1. Unmarried women of age <18 yrs. and >40 yrs.
2. Patient with Pelvic inflammatory disease, Cervicitis or other
vaginal infections like Trichomoniasis or candida etc. or non infectious vulvo-vaginitis/ cervicitis.
3. Patients with evidence of malignancy or cervical intra epithelial neoplasia or cervical carcinoma.
4. Patient with history of untreated sexually transmitted disease
or known to be HIV positive.
5. Patient with positive pregnancy test/ Lactating woman.
6. Patient has received antifungal or antimicrobial therapy
(systemic or intra-vaginal) within last 14 days prior to
enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure from symptoms and signs of Sweta Pradara with special <br/ ><br>reference to Bacterial Vaginosis. <br/ ><br>Timepoint: 85-90 days
- Secondary Outcome Measures
Name Time Method Cure of associated symptoms like burning, pain, itching and <br/ ><br>low backacheTimepoint: 90 days