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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea (PD)
• Intervention / Treatment: Dietary supplement: Ophiocephalus striatus extract

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • South Sumatra
    • Palembang, South Sumatra, Indonesia, 30114
      • Faculty of Medicine, Universitas Sriwijaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The experimental group received Ophiocephalus striatus extract in capsule form at a dosage of 2x500mg per day for 14 consecutive days, starting from the 14th day before their next menstruation. Evaluation of drug side effects and medication adherence was conducted by communicating with the respondents via the WhatsApp application. The Ophiocephalus striatus extract used in this study was in the form of 500 mg capsules containing 30% albumin.	Dietary supplement: Ophiocephalus 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.
Placebo Comparator: Placebo Group; The placebo group was given placebo 2x1 per day for 14 consecutive days, starting on the 14th day before the next menstruation, an evaluation of the side effects of the drug and compliance with taking the drug was carried out by communicating with respondents via the WhatsApp application. 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).	Dietary supplement: Ophiocephalus 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Menstrual Pain Intensity	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.	Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Level	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).	Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)
Change in Serum Interleukin-6 (IL-6) Level	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).	Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)
Change in Serum C-Reactive Protein (CRP) Level	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).	Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)

Collaborators and Investigators

• Sponsor: Universitas Sriwijaya

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: C-Reactive Protein; Primary dysmenorrhea; Albumin; interleukin-6; tumor necrosis factor-alpha; Ophiocephalus Striatus
• Other Study ID Numbers: 070/196/Ban.KBP/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No