Integrative Treatment with medications, therapy, diet, and yoga for functional pain disorders: comparative study by measuring serum inflammatory markers

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Integrative Treatment Approach Pharmacotherapy with Psychosomatic therapy, dietary modification, and yoga based interventions.: Conventional treatment with pharmacotherapy as follow Escitalopram‐ up to 20 mg OR Paroxetine up to 37.5 mg OR Desvenlafaxine up to 100 mg OR Duloxetine up to 80 mg OR low dose Amitriptyline up to 75 mg OR high dose Amitriptyline up to 225 mg Along with yoga‐based intervention (30 minutes of yoga module for 6 weeks) plus psychosomatic therapy (psychotherapy for 3 sessions) plus dietary modification (avoiding dietary allergens) Control Intervention1: Conventional Treatment Approach would include only pharmacotherapy and psychoeducation.: Routine medications as follow Escitalopram‐ up to 20 mg OR Paroxetine up to 37.5 mg OR Desvenlafaxine up to 100 mg OR Duloxetine up to 80 mg OR low dose Amitriptyline up to 75 mg OR high dose Amitriptyline up to 225 mg and psychoeducation component (single session) CONDITION: Health Condition 1: F450‐ Somatization disorder PRIMARY OUTCOME: 1. Efficacy of ITA over conventional treatment in patients with Bodily Distress Disorder in terms of percentage of improvement in psychological symptoms ; Timepoint: Baseline, 6 weeks, 14 weeks SECONDARY OUTCOME: 1. Tolerability of ITA over conventional treatment in patients with Bodily Distress Disorder in terms of percentage of improvement in psychological symptoms ; 2. Patientâ??s preference for ITA over conventional treatment in patients with Bodily Distress Disorder ; 3. Correlation of psycho‐immunological biomarkers with improvement in psychological symptoms in both the armsTimepoint: baseline, 6 weeks, 14 weeks INCLUSION CRITERIA: 1. Bodily distress disorder as per ICD‐11 clinical criteria. 2. Any Comorbid diagnosis of other Common Mental Disorders (CMD)
Epistemonikos ID: 14ca4145ca1d434039f1b8774217b2a6ff976cd6
First added on: Feb 20, 2024