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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Menstrual Pain Intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Menstrual Pain Intensity
时间窗: 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.
次要结局
- 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))
- 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))
- 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))
研究者
Legiran
Principal Investigator
Universitas Sriwijaya