Health Condition 1: K590- Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Individuals diagnosed with chronic functional constipation as per Rome IV criteria 2) Between 18 to 70 years of age 3) Willing to participate in 12week yoga intervention 4) Able to perform yogic practices
Exclusion criteria
Exclusion criteria: 1) Individuals with any structural disease of the GI tract 2) Individuals with Secondary Causes of Constipation a. Uncontrolled metabolic disturbances (diabetes, hypothyroidism, hypercalcemia, panhypopituitarism and pheochromocytoma) b. Medications (Analgesics like opioids and nonsteroidal anti-inflammatory agents, anticholinergics including antidepressants and antipsychotics, anti-hypertensives like calcium channel blockers, diuretics and iron supplementation) c. Neurological disorders (Parkinson’s disease, multiple sclerosis, dementia, Hirschprung’s disease and spinal cord lesions) d. Myopathic diseases (Scleroderma, myotonic dystrophy and amyloidosis), Structural disorder (Colon cancer, strictures and a large rectocele). 3) Patients already taking any other therapy (beyond standard care) for constipation should also be excluded, if not ready to stop 4) Participating in any other trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of Laghu Shankh Prakshalana (LSP) as an adjuvant therapy on change of Cleveland Severity Score among constipated adults compared to standard care alone group.Timepoint: To assess the effectiveness of Laghu Shankh Prakshalana (LSP) as an adjuvant therapy on change of Cleveland Severity Score among constipated adults compared to standard care alone group. | — |
Secondary
| Measure | Time frame |
|---|---|
| i) To assess the effect of LSP as an adjuvant therapy in chronic functional constipation through • Constipation related quality of life by PAC-QOL • Symptom management of constipation by PAC-SYM • Psychological parameters (depression, anxiety, stress) by DASS 21 • Bowel regularity by bowel diary ii) To assess the adverse effects of LSP among adults with chronic functional constipation iii) To assess need of escalation and de-escalation of drugs used in standard care in study populationTimepoint: To assess the effectiveness of Laghu Shankh Prakshalana (LSP) as an adjuvant therapy on change of Cleveland Severity Score among constipated adults compared to standard care alone group. | — |
Countries
India
Contacts
AIIMS RISHIKESH