Health Condition 1: N899- Noninflammatory disorder of vagina, unspecified Health Condition 2: null- suffering with Sweta Pradara, Leucorroea (Bacterial Vaginosis)
Conditions
Interventions
Intervention1: Pushyanug Churna: 3 gms BD Oral with Tandulodaka(Rice washed water)after meals for two months
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Percentage of participants with clinical cure after end of the treatment schedule of 2 months. •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% Timepoint: Base line 60th day 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| •Bacteriological cure of Bacterial Vaginosis (gram stain Nugent score less than 4). •Change in quality of life by using SF-36. Timepoint: Base line 60th day 90th day | — |
Countries
India
Contacts
Public ContactDr Savita Sharma
Regional Ayurveda Research Institute for Mother and Child Health
Outcome results
None listed