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

Universitas Sriwijaya

Status: Completed

Conditions: Primary Dysmenorrhea (PD)

Treatments: Dietary Supplement: Ophiocephalus striatus extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07677462

070/196/Ban.KBP/2023

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 10 to 19 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ophiocephalus striatus extract

Placebo Group

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Ophiocephalus striatus extract