Efficacy and safety of kosthasuddhikriya( an Yogic technique) versus Prucalopride for treatment of patients with functional constipation.

Efficacy and safety of kosthasuddhikriya versus Prucalopride in patients with functional constipation: a pilot non-inferiority randomized controlled trial. - YOGIC Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084034

Enrollment

Registered

2025-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: KOSTHASUDDHIKRIYA(KSK): KSK is a sequential of yoga asanas comprising of Tadasana(Palm tree pose), tiryaka tadaasana(swinging palm tree pose), katichakarasna(satnding spinal twist pose)

Eligibility

Inclusion criteria

Inclusion criteria: Male and non-pregnant female subjects (18-65 years of age) with clinical diagnosis of functional constipation (As per ROME IV criteria) with BMI of 18-35 Kg/m2 will be included in the trial, Willing to comply with protocol requirements and sign a statement of informed consent, Willing to stop any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories),Agree to abstain from making any fresh, significant lifestyle adjustments that might impact symptoms (such as altering their workout regimen or nutrition) between the time the ICF was signed and the final trial visit.

Exclusion criteria

Exclusion criteria: age less than 18 and more than 65 with significant comorbidity like uncontrolled diabetes, uncontrolled hypertension secondary Constipation due other disease or drug, IBD, past GI surgery, Pregnant and lactating mothers, People with HCV/HBV/HIV seropositive, not willing to give consent, not able to perform KSK asana due to muskuloskeletal disoredes will be excluded

Design outcomes

Primary

Measure	Time frame
To determine and compare the efficacy of Kosthasuddhikriya (KSK) with Prucalopride for treatment of Functional Constipation in terms of Complete spontaneous bowel movement per week (CSBM) and Bristol stool form scale (BSFS). Timepoint: At baseline, 4 WEEKS, 8 WEEKS	—

Secondary

Measure	Time frame
To determine the efficacy of KSK for treatment of patients with Functional constipation in terms of various GI symptom scores Change in average weekly Abdominal pain/bloating/straining/sense of incomplete evacuation scores.Timepoint: At 2,4,6,8 week of intervention;To evaluate the safety and acceptability of KSK as a treatment of patients with Functional constipation.Timepoint: At 8 week;To determine the proportion of patients requiring rescue treatment in both study arms.Timepoint: At 8 week of intervention	—

Measure

Time frame

To determine the efficacy of KSK for treatment of patients with Functional constipation in terms of various GI symptom scores Change in average weekly Abdominal pain/bloating/straining/sense of incomplete evacuation scores.Timepoint: At 2,4,6,8 week of intervention;To evaluate the safety and acceptability of KSK as a treatment of patients with Functional constipation.Timepoint: At 8 week;To determine the proportion of patients requiring rescue treatment in both study arms.Timepoint: At 8 week of intervention

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Countries

India

Contacts

Public ContactManas Kumar Panigrahi

AIIMS, Bhubaneswar

subhabratabiswal001@gmail.com9556565181

Outcome results

None listed

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