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

27 giugno 2026 aggiornato da: Legiran, Universitas Sriwijaya

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.

Panoramica dello studio

Stato

Completato

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Comparatore placebo: 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).
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Menstrual Pain Intensity
Lasso di tempo: 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.
Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Level
Lasso di tempo: 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).
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
Lasso di tempo: 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).
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
Lasso di tempo: 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).
Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2023

Completamento primario (Effettivo)

30 giugno 2023

Completamento dello studio (Effettivo)

30 giugno 2023

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 070/196/Ban.KBP/2023

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dismenorrea primaria (PD)

Prove cliniche su Ophiocephalus striatus extract

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