A clinical trial to study the effect of an Ayurvedic formulation - Pushyanug Churna in the management of Sweta Pradara / White discharge from vagina (Leucorrhoea)
- Conditions
- Health Condition 1: N899- Noninflammatory disorder of vagina, unspecifiedHealth Condition 2: null- suffering with Sweta Pradara, Leucorroea (Bacterial Vaginosis)
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 67
1.Married women with regular menstrual cycle.
2.Presence of 3 out of 4 Amsel’s diagnostic criteria for Bacterial Vaginosis:
a) Off white (milky or gray), thin, homogeneous, adherent vaginal discharge, with minimal or absent pruritis.
b) Vaginal pH > 4.5
c) Positive whiff test ? (fishy odor of the vaginal discharge with the addition of a drop of 10% KOH).
d) 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 anti-fungal agents or lubricants during the entire study period.
4.Patient willing and agrees to participate for three months and signs informed consent.
1.Patient with Pelvic inflammatory disease, Cervicitis or other vaginal infections like Trichomoniasis or candida etc or noninfectious vulvo-vaginitis/ cervicitis.
2.Patients with evidence of malignancy or cervical intra-epithelial neoplasia or cervical carcinoma.
3.Patient with history of untreated sexually transmitted disease or known to be HIV positive.
4.Patient with positive pregnancy test/ Lactating woman.
5.Patient has received antifungal or antimicrobial therapy (systemic or intra-vaginal) within last 14 days prior to enrollment.
6.Patient with PAP smear more than or equal to LSIL.
7.Patient using intrauterine implantable devices [IUD], intrauterine system [IUS] and vaginal rings as a method of birth control.
8.Raised liver enzymes twice the upper limit of normal & creatinine more than 1.4 mgm%.
9.Patient with poorly controlled Hypertension (more than or equal to 160/100 mm of Hg).
10.Patient with poorly controlled Diabetes Mellitus{B.S. (F) more than 130 mg% and or B.S. (2 hr. PP) more than 250 mg% & HbA1c more than 6.5%}.
11.Patient on prolonged (more than 6 weeks) medication with oral contraceptives, HRT, corticosteroids, antidepressants, anti-cholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
12.Patient who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
13.H/o hypersensitivity to the trial drug or any of its ingredients.
14.Patients who are currently participating in any other clinical trial or participated in past 6 months.
15.Any other condition which the Principal Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Percentage of participants with clinical cure after end of the treatment schedule of 2 months. <br/ ><br> <br/ ><br>•Resolution of 3 out of 4 Amsel’s criteria, i.e. vaginal discharge, negative whiff test ?, Vaginal pH less than 4.5, clue cells less than 20% <br/ ><br>Timepoint: Base line <br/ ><br>60th day <br/ ><br>90th day <br/ ><br>
- Secondary Outcome Measures
Name Time Method •Bacteriological cure of Bacterial Vaginosis (gram stain Nugent score less than 4). <br/ ><br> <br/ ><br>•Change in quality of life by using SF-36. <br/ ><br>Timepoint: Base line <br/ ><br>60th day <br/ ><br>90th day <br/ ><br>