This study compares the safety and effectiveness of three treatments for moderate to severe pain, such as cramps, stomach or kidney pain, back pain, or post-surgery pain. The treatments combine medicines to relieve both pain and muscle spasms.

A 3arm Multicenter, Open label, Randomized Controlled Study Comparing FDC (Diclofenac 50mg plus Paracetamol 325 mg and Dicyclomine HCL 20 mg) and Spasmodart FDC (Fixed-dose Combination of Paracetamol IP 325 mg, Dicyclomine Hydrochloride IP 20 mg and Diclofenac Sodium IP 50 mg ), Phase-IV Clinical study to Evaluate Safety, Tolerability and Efficacy of in moderate to severe pain associated with Primary dysmenorrhoea, Gastro-intestinal colic, Renal colic, Biliary colic, Uterine colic, Spasmodic dysmenorrhoea, Backache, Surgical pain and spasm. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091774

Enrollment

210

Registered

2025-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: R252- Cramp and spasm

Interventions

Intervention1: Spasmodart: Arm I: Spasmodart Each uncoated tablet contains: Paracetamol IP 325 mg Dicyclomine Hydrochloride IP 20 mg Diclofenac Sodium IP 50 mg Dosage- 1 tablet to be taken thre

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of either sex aged between 18 to 60 years 2. Subjects clinically diagnosed with moderate to severe pain (on VAS) due to Primary dysmenorrhoea, Gastro-intestinal colic, Renal colic, Biliary colic, Uterine colic, Spasmodic dysmenorrhoea, Backache, Surgical pain & spasm. 3. Subjects who are willing to comply with protocol procedures. 4. Subject who voluntary participate in the study with signed inform consent.

Exclusion criteria

Exclusion criteria: 1. Not willing to sign ICF 2. Subjects known, or thought to be hypersensitivity, to Paracetamol, Dicyclomine Hydrochloride, Diclofenac Sodium 3. Pregnant and lactating women 4. Subjects with a history of hypersensitivity to Paracetamol, Dicyclomine Hydrochloride, Diclofenac Sodium 5. Subjects having secondary dysmenorrhoea 6. Subjects having mild menstrual pain 7. Subjects with prostatic hypertrophy 8. Subjects with history of glaucoma and Myasthenia 9. Subjects with mechanical stenosis 10. Subjects with history of severe gastritis, peptic ulceration or any gastrointestinal bleeding 11. Subjects with serious underlying organic disorders 12. Subjects with paralytic ileus 13. Subjects with renal or hepatic disorders 14. Subjects with previous history of heart problems or stroke 15. Subjects with history of acute pancreatitis and biliary disorder other than colicky pain 16. Subjects with severe renal disorder 17. History or evidence of significant cardiovascular disease, any malignancy, thyroid dysfunction, epilepsy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment. 18. Participation in other clinical trials the last three months and doing study

Design outcomes

Primary

Measure	Time frame
To assess the Pain relief using Visual Analogue Scale (VAS)Timepoint: 2,6,12, 24, 72, 96 hours after post dose	—

Secondary

Measure	Time frame
Physician s Global evaluation through CGI-I scale Safety and tolerability of the study drug(s) will be assessed by the Clinical & Laboratory AEs occurring during entire duration of study.Timepoint: Baseline to Day 5	—

Countries

India

Contacts

Public ContactDr Ashwini Kumar

CliniExperts Research Services Pvt. Ltd.

veena.rm@cliniexpertsresearch.com09880902005

Outcome results

None listed

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