terine Fibroids-Effect of Ayurvedic regime
- Conditions
- Health Condition 1: null- Uterine Fibroids
- Registration Number
- CTRI/2014/09/005018
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
Symptomatic Females, 25-50 yrs
Uterine fibroids, uterine size < 12 weeks, and at least one fibroid >2 cm but none >5 cm on U/S
Pre menopausal ladies with Uterine Fibroids getting at least 1 menstrual period in last three months.
Normal PAP smear.
Pregnancy, Lactation.
Unexplained vaginal bleeding, cervical dysplasia, abnormal ovarian or adnexal mass.
History of malignancy within the past 5 years.
Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.
Use of herbal medication having estrogenic or antiestrogenic effect within the past 3 months.
Known recent rapid growth of fibroids, defined as a doubling in size in six months.
Haemoglobin level below 8gm%
Patients suffering from any other major systemic illness necessitating long term drug Therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the clinical symptomsTimepoint: At base line 30th day, 60th day, 90th day, 120th day, 150th day and 180th day i.e at the time of trial completion
- Secondary Outcome Measures
Name Time Method Changes in the size of fibroidsTimepoint: At the screening day, 90th day and end of the study (180th day)