Health Condition 1: N889- Noninflammatory disorder of cervixuteri, unspecified Health Condition 2: N80-N98- Noninflammatory disorders of female genital tract
Conditions
Interventions
Intervention1: Shatavari Guda and Triphala Kashaya Douch: Shatavari Guda, 10 gm twice daily for three cycle and triphala kwath vaginal douch for two cycle.
Control Intervention1: nil: nil
Sponsors
Central Council for Research in Ayurvedic Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1 Married woman of age between 18 to 40 years. 2 Vaginal white discharge with or without associated symptoms since one month 3 Women agree to refrain from use of other douches, oral or intra-vaginal antibiotics or antifungal agents or lubricants during the entire study period. 4 Willing and ability to give written consent to participate in the study.
Exclusion criteria
Exclusion criteria: • Post-menopausal women and women undergone hysterectomy. • Pregnant or Lactating women. • Patients on Oral Contraceptive Pills or IUCD. • Patients with physiological leucorrhoea (e.g. during ovulation, pre-menstrual period) • Patients with abnormal (excessive) vaginal discharge due to neoplasmic changes, cervical intra-epithelial neoplasia or cervical carcinoma. • Severe Anaemic (Hb% • Immunocompromised states and patients with systemic infections or known cases of AIDS, HIV, STD etc. • Patients with history of cardiac, hepatic, cerebrovascular disease, pulmonary dysfunction, malignancy, chronic uncontrolled systemic diseases or renal disorder ( S. Creatinine >1.2 mg/dl) etc or poorly controlled Hypertension (Blood pressure more than 160/100mm of Hg), uncontrolled Diabetes Mellitus (HbA1c >= 8), or any other serious medical illness. • Patients on medication with corticosteroids or any other drugs that may have an influence on the outcome of the study. • Women who have received antifungal or antimicrobial therapy (systemic or intra-vaginal) in the last one month prior to screening. • History of hypersensitivity to the trial drug or any of its ingredients. • Patients who have completed participation in any other clinical trial during the past 03 months. • Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the symptom vaginal white discharge by using Visual Analogue Scale Timepoint: Baseline, 14th day ,28th , 56th& 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in other associated symptoms like pruritus vulva, lower abdominal pain, low back ache, burning micturition, dyspareunia by using Visual Analogue Scale [Time frame: Baseline, 28th , 56th& 84th day] Clinical safety of the drugs in patients suffering from Leucorrhea [Time frame: Baseline and 84th day] Changes in the Quality of life and wellbeing as per SF-36 score.[Time frame: Baseline and 84th day] Changes in Score of Investigatorâ??s Global Satisfaction Scale[Time frame:Timepoint: Baseline 14th , 28th, 42nd , 56th ,70th and 84th day] | — |
Countries
India
Contacts
Public ContactDr Savita Poshatti Gopod
Regional ayurveda research institute Vijayawada
Outcome results
None listed