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Efficacy of Ajamoda Arka with Yava Kshara in the Management of Vataja Udarashoola, Infantile Colic in infants with the age group 1 to 5 months for the duration of 15 days

Efficacy of Ajamoda Arka with Yava Kshara in the Management of Vataja Udarashoola, Infantile Colic - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070107
Enrollment
50
Registered
2024-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: R108- Other abdominal pain

Interventions

None listed

Sponsors

Dr Tale Vaibhav Vitthalrao
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Infants of either gender diagnosed with infantile colic as per ROME IV criteria 2.Infants aged 1 month to 5 months 3.Infants with recurrent and prolonged periods of crying, fussiness or irritability as reported by care givers that occur without any apparent cause and cannot be prevented or consoled by care givers 4.Full term healthy neonates 5.Mothers and care givers who are willing to participate and ready to give written consent

Exclusion criteria

Exclusion criteria: 1.Infants with disorder of bowel or urinary tract disorders that might present as abdominal distension, inguinal swelling or scrotal swelling. 2.Infants with chronic or acute systemic illnesses of gastrointestinal, Respiratory etc. 3.Infants with known cases of chromosomal, metabolic and hereditary Disorders. 4.Infants or their who are on medication or diet that may interfere with study objectives. 5.Breast feeding mothers or their kids on antibiotic therapy in the last 15 days. 6.Mothers who consume alcohol, smoke and tobacco. 7.Infants who are on formula feed or animal(feed) milk.

Design outcomes

Primary

MeasureTime frame
1)Reduction in the clinical features of Vataja udara shoola. 2)Reduction in the Intensity of cry & fussing by FUSSINESS rating scale. Timepoint: Baseline, 15 Days

Secondary

MeasureTime frame
1) Decrease in Pain, improvement in activity and sleep behaviour based on FLACC scale. 2) Improvement in the Gastro intestinal features- IGSQ score. Timepoint: Baseline, 15 Days

Countries

India

Contacts

Public ContactDr Tale Vaibhav Vitthalrao

Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore

drreenakulkarni@gmail.com9480478639

Outcome results

None listed

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