A scientific Study to check the Safety and Effectiveness of Tablets ANAFORTAN-MFÂ® in patients associated with pain in the lower abdomen occurring just before or during menstruation.

A Prospective, Single-Arm, Open-Label Study to Determine the Safety and Effectiveness of ANAFORTAN-MFÂ® Tablets (Fixed Dose Combination of Camylofin Dihydrochloride 50 mg plus Mefenamic Acid I.P. 250 mg) in Primary Dysmenorrhea in India.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017335

Enrollment

274

Registered

2019-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N944- Primary dysmenorrhea

Interventions

Intervention1: ANAFORTAN-MFÂ®: Fixed Dose Combination of Camylofin Dihydrochloride 50 mg + Mefenamic Acid I.P. 250 mg Dosage and frequency: One tablet thrice daily Route of administration: Orally Tota

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women >=18 years of age with a history of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles 2. Women presenting with dysmenorrhea on the 1st or 2nd day of their current menstrual cycle 3. Women willing and able to provide written informed consent by signing the informed consent form (ICF)

Exclusion criteria

Exclusion criteria: 1. Women with a history of taking Anafortan-MFÂ® or any other prescription-only and/or nonprescription analgesics, antispasmodics, antidepressants, or antipsychotic medication (within the previous 4 weeks before study enrolment) 2. Pregnant or Lactating women 3. Women with organic dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis) 4. Women using an intrauterine contraceptive device (IUCD) 5. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments 6. History of hypersensitivity to study drug (Anafortan-MFÂ®) 7. Women who are allergic to (Anafortan-MFÂ®) or any of the study drug ingredients, have undergone coronary artery bypass graft surgery, epilepsy, hypersensitivity, and/or inflammatory bowel disease 8. Any other illness or conditions that does not justify the womanâ??s participation in the study as judged by the Investigator 9. Woman not willing to comply with the study procedures

Design outcomes

Primary

Measure	Time frame
To assess the safety of Anafortan-MFÂ® in women with primary dysmenorrheaTimepoint: 4 days or 6 Days (Depends on physician discretion)	—

Secondary

Measure	Time frame
To determine the effect of Anafortan-MFÂ® on pain intensity through VAS scale for the treatment of women with primary dysmenorrhea To determine the effect of Anafortan-MFÂ® on the frequency of daily pain episodes over a 3-day or 5-day course of treatment (as per physicianâ??s discretionTimepoint: 4 days or 6 days (Depends on physician discretion)	—

Countries

India

Contacts

Public ContactMr Satish Marukurthi

Accent Pharma

qapondy@accentpharma.in9750983636

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026