Primary Dysmenorrhea (PD)NCT07677462
The Relationship Between Ophiocephalus Striatus Extract and Serum TNF-α, IL-6, and CRP Levels in Primary Dysmenorrhea
A study testing Ophiocephalus striatus extract in people with Primary Dysmenorrhea (PD), run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Ophiocephalus striatus extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Sriwijaya
Palembang, South Sumatra, 30114
About this study
Official 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
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.
Read more
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.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Ophiocephalus striatus extract
- Keywords
- Primary dysmenorrhea, C-Reactive Protein, tumor necrosis factor-alpha, interleukin-6, Albumin, Ophiocephalus Striatus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophiocephalus striatus extractDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Dietary Supplement: Ophiocephalus striatus extract |
| Placebo Group | Placebo comparator | 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). Receives: Dietary Supplement: Ophiocephalus striatus extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: Baseline (first/second day of menstruation prior to intervention) and post-intervention (first/second day of menstruation after completing 14 days of supplementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Legiran, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677462
- Sponsor's protocol ID
- 070/196/Ban.KBP/2023
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07677462
- Acronym / sponsor ID
- 070/196/Ban.KBP/2023
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Primary dysmenorrhea, C-Reactive Protein, tumor necrosis factor-alpha, interleukin-6, Albumin, Ophiocephalus Striatus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Ophiocephalus striatus extractThe 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. |
| Placebo Group | Placebo comparator | Dietary Supplement: Ophiocephalus striatus extractThe 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). |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophiocephalus striatus extractRandomised 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. | Dietary supplement | Intervention, Placebo Group |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophiocephalus striatus extract in people with Primary Dysmenorrhea (PD), run by Universitas Sriwijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.