This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.
There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1442 at a dose of 3 x 100 mg daily, or 2) DLBS1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x 500 mg daily. DLBS1442 will be taken every day along the study period (8 weeks), while mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. Study treatment will be given at a standardized starting point for all subjects, i.e. on the first day of their respective menstrual periods. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and every 4-week interval throughout the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
Control will be mefenamic acid 500 mg tablets, administered 3 times daily for 5 days during the menstrual period, i.e. day 1st to day 5th of the menstrual period. The drug will be given within the 8 weeks of study period (2 menstrual cycles).
Study treatment will be DLBS1442 capsules at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Department of Obstetrics and Gynecology, RSUP Persahabatan
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Department of Obstetrics and Gynecology RSUP Fatmawati
Jakarta, Indonesia
Reduction of intensity (VAS) of composite-pain
Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Time frame: Week 8
Reduction of the intensity of each pain (VAS)
Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Time frame: Week 4, week 8
Response rate
Response rate is defined as percentage of subjects at the end of study experiencing a reduction of VAS score of \>= 3 or \>= 30% as compared to baseline, in each of the composite pain found at baseline (i.e. dysmenorrhea, dyspareunia, non-menstrual pelvic pain, dysuria, or dyschezia).
Time frame: Week 8
Improvement of quality of life
Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.
Time frame: Week 4, week 8
Serum CA-125
Reduction in serum CA-125 level.
Time frame: Week 8
IL-6
Change of IL-6
Time frame: Week 8
Number of rescue medication
Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.
Time frame: During the course of the study
Pain-free period
Time to the first day on which subjects take rescue medication.
Time frame: During the course of the study
Percentage or proportion of subjects who complete the study
Percentage or proportion of subjects who complete the study (2 cycles).
Time frame: Week 8
ECG
Electrocardiography.
Time frame: Week 8
Vital signs
Vital signs measured include: blood pressure, heart rate, respiratory rate.
Time frame: Week 4, week 8
Liver function
Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).
Time frame: Week 8
Renal function
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).
Time frame: Week 8
Routine hematology
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Time frame: Week 8
Adverse event
Adverse event will be observed and managed along the study course.
Time frame: During the course of the study
Reduction of intensity (VAS) of composite-pain
Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Time frame: 4 weeks
hs-CRP
Change in serum hs-CRP.
Time frame: Week 8
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