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Clinical Trials in India / NCT04654377
Starting soon Not applicable

Personalized Education and Pain Response in Chronic Pancreatitis

NCT04654377 · tracked via the Priya Life Science India tracker
Sponsor
Asian Institute of Gastroenterology, India
Phase
Not applicable
Started
2025-08-01
Last updated
2025-07-30

Condition(s) studied

Chronic PancreatitisPain SyndromeDepression, Anxiety

Investigational drug(s) / intervention(s)

Personalised education

Personalised education: Patients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.

Study summary

Pain mechanisms in chronic pancreatitis (CP) are heterogeneous and includes nociception, pancreatic neuropathy and central neuropathy/neuroplasty. These mechanisms could occur simultaneously in variable proportions and could explain why several patients develop recurrence of pain even after being treated by all the currently available modalities, such as antioxidants, endoscopic therapies and surgery.

In the studies by the investigators over the past 2 years, they observed that persistent pain in these patients was associated with varying grades of depression and poor quality of life. This was accompanied by alteration in the metabolites in the brain (anterior cingulate cortex, prefrontal cortex, hippocampus, and basal ganglia) as evidenced in magnetic resonance spectroscopy (MRS) of the brain. These areas in the brain are responsible for pain modulation, long-term pain memory and emotional responses to pain.

When the investigators counselled these patients and explained their disease and possible outcomes based on their own clinical course, imaging and treatment response (personalized education/counselling), they reported significant improvement in depression, quality of life parameters and, interestingly, also in pain. Further, there were changes in the metabolite parameters in the brain on MRS after personalized counselling/education that was more similar to that of healthy controls.

This led to our hypothesis that better understanding of the disease and its outcomes by the patients could improve their coping capabilities and increase their pain thresholds. This could augment the pain responses of these patients to the other therapeutic modalities.

We will conduct this single blinded, placebo controlled, randomized controlled trial on patients with documented CP of over 3 years duration, who had at least 3 episodes of abdominal pain of over the past 3 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Chronic pancreatitis of at least 3 years * At least 3 episodes of pain in the past 3 months * Age 18-60yrs * Both genders Exclusion Criteria: * Acute pancreatitis episode at the time of enrolment. * Pancreatic cancer. * Other chronic diseases (including end organ damage related to diabetes). * Adverse life event in the family in the past 6 months. * Active substance use (alcohol, smoking, smokeless tobacco, Illicit drugs). * Pregnancy and lactation. * Psychiatric illness at enrolment or during follow-up, and/or concomitant intake of antidepressants and neuromodulators..

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asian Institute of Gastroenterology Hyderabad Telangana

More Asian Institute of Gastroenterology, India trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04654377 on ClinicalTrials.gov ↗ ← All trials in India