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Completed

NCT Number: NCT07677462

The Relationship Between Ophiocephalus Striatus Extract and Serum TNF-α, IL-6, and CRP Levels in Primary Dysmenorrhea

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.

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Key information

Age range

10 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Sriwijaya

Palembang, South Sumatra, 30114, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ophiocephalus striatus extract

Dietary Supplement

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.

Primary outcomes

  1. Change in Menstrual Pain Intensity

    Time frame: 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 outcomes

  1. Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Level

    Time frame: 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).

  2. Change in Serum Interleukin-6 (IL-6) Level

    Time frame: 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).

  3. Change in Serum C-Reactive Protein (CRP) Level

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Registry information

Official study title

The Relationship Between the Administration of Ophiocephalus Striatus Extract and Serum Levels of Tumor Necrosis Factor-Alpha (TNF-α), Interleukin-6 (IL-6), and C-Reactive Protein (CRP) in Primary Dysmenorrhea

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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