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Study of efficacy of the drug amitriptyline in reducing pain symptoms in children with functional abdominal pain: comparison with placebo.

Randomized placebo-controlled trial with amitriptyline in children with functional abdominal pain disorders (FAPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015365
Enrollment
192
Registered
2018-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system Health Condition 2: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Amitriptyline: After one month of observation, children with functional abdominal pain disorders will be randomized to either amitriptyline (10mg daily in less than 35kg body weight and

Sponsors

Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All children attending Pediatric Gastroenterology out patient department diagnosed to have functional abdominal pain disorders (FAPD), fulfilling Rome IV criteria. 2.Children from 7 to 18 years of age group of either sex. 3.Consent to take part in the study

Exclusion criteria

Exclusion criteria: 1. Children with pain abdomen who were found th have organic etiology on history, examination and investigations. 2. Children with known heart disease or ECG abnormality or family history of heart disease or psychiatric disorder. 3. Refusal to give consent.

Design outcomes

Primary

MeasureTime frame
Effect of amitriptyline on intensity, duration, frequency of pain and daily activity based on the PAIN SCORE TABLE.Timepoint: 12 weeks after starting the drug

Secondary

MeasureTime frame
Effect of amitriptyline on intensity, duration, frequency of pain and daily activity at 1 month of starting drug.Timepoint: 4 weeks after starting drug

Countries

India

Contacts

Public ContactDr Jayendra S

Sanjay Gandhi Postgraduate Institute of Medical Sciences

jayendra.seetharaman@gmail.com09176625263

Outcome results

None listed

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