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Efficacy of Matri in women with Primary Dysmenorrhoea

Efficacy of Indian make Transcutaneous Electric Nerve Stimulation Device Matri in women with Primary Dysmenorrhoea- A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077775
Enrollment
120
Registered
2024-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: N946- Dysmenorrhea, unspecified

Interventions

Intervention1: TENS Device Matri: Will be given for 2 months Control Intervention1: Placebo Device: Will be given for 2 months

Sponsors

Biotechnology ignition grant BIG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women suffering from primary dysmenorrhoea with regular cycles 2. Working ability, Location, Intensity, Days of dysmenorrhea score (WaLIDD score) more than or equal 5 3. Age 14 - 30 Years

Exclusion criteria

Exclusion criteria: 1. Women taking Oral Contraceptive Pills OCPs 2. Patients with dysmenorrhea secondary to the pathologies like endometriosis, uterine myoma, uterine malformations, other similar uterine diseases, pelvic inflammatory disease, congenital Mullerian anomalies, ovarian cysts, or inflammatory bowel disease.

Design outcomes

Primary

MeasureTime frame
1. To evaluate the effectiveness of the new Indian make TENS device (Matri) for managing Primary Dysmenorrhoea using subjective Visual Analog Scale pain score (VAS score)Timepoint: 1. To evaluate the effectiveness of the new Indian make TENS device (Matri) for managing Primary Dysmenorrhoea using subjective Visual Analog Scale pain score (VAS score) at base line , 1 month and 2nd month from base line

Secondary

MeasureTime frame
1. To assess the perceived adverse reactions of the new Indian make Transcutaneous Electric Nerve Stimulation TENS Device (Matri) 2. To compare the quality of life before & after intervention 3. To assess patient acceptance for new Indian make Transcutaneous Electric Nerve Stimulation TENS Device (Matri) for Primary DysmenorrhoeaTimepoint: 1. Quality of life will be assessed using WHO short survey questionnaire SF- 12 at baseline, at the end of second cycle & again at the end of fourth cycle. 2. Patient�s acceptance for new Indian make Transcutaneous Electric Nerve Stimulation TENS Device (MATRI) for Primary Dysmenorrhoea

Countries

India

Contacts

Public ContactMr Mukesh Kumar

Government Institute of Medical Sciences (GIMS)

drritu661@gmail.com9717001590

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026