Uterine fibroids Urological and Genital Diseases
Conditions
Interventions
Included participants will be randomly allocated to Arm I and Arm II to receive Ayurveda treatment regimen with oral and external administration for 12 weeks. The drug regimen is the same for the init
Sponsors
University of Colombo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who are in reproductive age between 18 to 50 years 2. Ability to take medication and be willing to adhere to the medication regimen 3. Willing and able to give informed consent 4. Have at least one fibroid (diameter =2 cm) confirmed by pelvic ultrasound
Exclusion criteria
Exclusion criteria: 1. Women who had used any steroid hormonal therapy for a minimum of 3 months prior 2. Lactating females 3. Menopausal women 4. Under the inclusion age limit 5. Menorrhagia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of the largest fibroid measured using TVS/TAS at baseline and the end of intervention (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire at baseline and the end of the intervention (12 weeks) 2. Effect of the drug regimens according to the body constituents (Ayurveda body type) measured using questionnaire at the end of the intervention (12 weeks) 3. Changes of the serum hormone levels; estrogen (E2), FSH measured by serum investigations at baseline and at the end of intervention (12 weeks) | — |
Countries
Sri Lanka
Contacts
Public ContactPathirage Kamal Perera
Outcome results
None listed