To evaluate the safety and effectiveness of AnafortanÂ® syrup (Camylofin Dihydrochloride 12.5 mg plus Paracetamol IP 125 mg) in Indian children presenting with acute colicky i.e. spasmodic abdominal pain.

A Prospective, Single Arm, Open Label, Multicentric Study to Determine the Safety and Effectiveness of AnafortanÂ® Syrup (Camylofin Dihydrochloride 12.5 mg plus Paracetamol IP 125 mg)/ 5 ml in Children with Acute Colicky Abdominal Pain in India - AHPLIN1702

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/015902

Enrollment

197

Registered

2018-10-05

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: K529- Noninfective gastroenteritis and colitis, unspecified

Interventions

Intervention1: Camylofin Dihydrochloride: Camylofin Dihydrochloride 12.5mg/5ml dose of 2 teaspoons (10 mL) thrice a day orally Intervention2: Paracetamol IP: Paracetamol IP 125mg/5ml dose of 2 teaspoo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of either gender aged 8 to12 years 2. Children presenting with acute colicky abdominal pain and having history of at least one episode of acute colicky abdominal pain in the 24-hour period prior to screening 3. Children willing to provide assent and parents/ legal guardian /legally acceptable representative (LAR) willing to give written informed consent for participation of their children

Exclusion criteria

Exclusion criteria: 1. Children with history of taking AnafortanÂ® syrup or any other prescription analgesics and antispasmodics medication (within the previous 1 week before study enrollment). 2. Parents/legal guardian/LAR unwilling or unable to comply with the study procedures and/or make daily diary entries for their children 3. History of hypersensitivity/ allergy to study drug and its constituents 4. Any other illness or conditions that does not justify patientâ??s participation in the study as judged by the investigator

Design outcomes

Primary

Measure	Time frame
To determine the safety of AnafortanÂ® syrup in children with acute colicky abdominal painTimepoint: 5-day course of treatment	—

Secondary

Measure	Time frame
To assess the tolerability of AnafortanÂ® syrup in children with acute colicky abdominal painTimepoint: EOT;To determine the effect of AnafortanÂ® syrup on pain intensity for the treatment of children with acute colicky abdominal painTimepoint: 5-day course of treatment;To determine the effect of AnafortanÂ® syrup on the frequency of daily pain episodes over 5-day course of treatmentTimepoint: 5-day course of treatment;To determine the percentage of patients with meaningful pain relief from baseline to end of treatment (EOT)Timepoint: EOT;To determine the physicianâ??s global assessment (PGA) of pain (based on effectiveness and tolerability) at EOTTimepoint: EOT	—

Measure

Time frame

To assess the tolerability of AnafortanÂ® syrup in children with acute colicky abdominal painTimepoint: EOT;To determine the effect of AnafortanÂ® syrup on pain intensity for the treatment of children with acute colicky abdominal painTimepoint: 5-day course of treatment;To determine the effect of AnafortanÂ® syrup on the frequency of daily pain episodes over 5-day course of treatmentTimepoint: 5-day course of treatment;To determine the percentage of patients with meaningful pain relief from baseline to end of treatment (EOT)Timepoint: EOT;To determine the physicianâ??s global assessment (PGA) of pain (based on effectiveness and tolerability) at EOTTimepoint: EOT

—

Countries

India

Contacts

Public ContactDr Shubhangi Desai

Abbott India Limited

shubhangi.desai@abbott.com2238160918

Outcome results

None listed

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