Primary Dysmenorrhea (PD)
Conditions
Keywords
Primary dysmenorrhea, C-Reactive Protein, tumor necrosis factor-alpha, interleukin-6, Albumin, Ophiocephalus Striatus
Brief summary
Primary dysmenorrhea is menstrual pain without any underlying pelvic disease. It affects many adolescent girls and can disrupt daily activities, school attendance, and quality of life. The pain is related to inflammation and the production of substances such as prostaglandins and inflammatory proteins like tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and C-reactive protein (CRP). Ophiocephalus striatus (also known as snakehead fish) is a freshwater fish traditionally used in Southeast Asia to help wound healing and reduce inflammation. It contains high levels of albumin, which has anti-inflammatory and antioxidant properties. This study was a double-blind, randomized, placebo-controlled trial conducted in Palembang, Indonesia. A total of 40 adolescent girls aged 13-19 years with moderate to severe primary dysmenorrhea were enrolled. They were randomly assigned to receive either Ophiocephalus striatus extract (500 mg capsules) or a matching placebo twice daily for 14 days before their expected next menstruation. Pain intensity was measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain). Blood samples were taken at the beginning and end of the study to measure serum levels of TNF-α, IL-6, and CRP using ELISA. The study found that after 14 days, girls who received the extract had a significant reduction in pain (average VAS decreased from 7.3 to 4.2). Their levels of TNF-α, IL-6, and CRP also decreased significantly. In the placebo group, pain also decreased but the inflammatory markers did not change significantly. No serious side effects were reported. This suggests that Ophiocephalus striatus extract may help reduce menstrual pain by lowering inflammation. Further research with larger groups and longer treatment periods is needed to confirm these findings.
Interventions
DIETARY_SUPPLEMENTOphiocephalus striatus extract
Randomised control trial, Ophiocephalus striatus group (n=20) receive 2x500mg (capsule), placebo group (n=20) receive 2x1 (capsule) for 14 days. VipAlbumin contains 30% albumin, which is believed to improve wound healing and reduce inflammation. The placebo used was a capsule containing flour packaged to resemble an OS extract capsule that would be produced by a third party (Kimia Farma Pharmacy). The intervention will begin on the 14th day of the participants' menstrual cycle, and participants' compliance and any adverse effects will be monitored through daily communication via WhatsApp.
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Adolescent girls aged 10-19 years who are diagnosed with primary dysmenorrhea with regular menstrual cycles. * Menstrual pain occurs at least 1 year after menarche. * Willing to participate in the study and approved by parents by signing an informed consent form.
Exclusion criteria
* Has a history of or is currently suffering from gynecological diseases obtained from the results of anamnesis that has been confirmed by an obstetrician-gynecologist. * Suffering from acute or chronic diseases, for example: fever, ARI, sore throat, toothache, ear inflammation, autoimmune, and systemic lupus erythematosus (SLE), rheumatoid arthritis. * Consuming corticosteroid drugs in the long term (for example: bethamethasone, dexamethasone, methylprednisolone, prednisolone, prednisone, triamcinolones, hydrocortisone, and cortisone) * History of hypersensitivity to Ophiocephalus striatus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menstrual Pain Intensity | Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation) | Menstrual pain intensity was measured using a 10-cm Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain imaginable. Participants were asked to rate their pain level at the time of assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Level | Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation) | Serum TNF-α concentration was measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Cloud-Clone Corp., cat. no. SEA133Hu). Results are expressed in picograms per milliliter (pg/mL). |
| Change in Serum Interleukin-6 (IL-6) Level | Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation) | Serum IL-6 concentration was measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Cloud-Clone Corp., cat. no. SEA079Hu). Results are expressed in picograms per milliliter (pg/mL). |
| Change in Serum C-Reactive Protein (CRP) Level | Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation) | Serum CRP concentration was measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Cloud-Clone Corp., cat. no. SEA821Hu). Results are expressed in milligrams per liter (mg/L). |
Countries
Indonesia
Outcome results
None listed