A single arm clinical study to evaluate the efficacy of Shatavari Ghrita in the management of Vibandha (Functional Constipation) in Children (5-10 years)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
.This is a single arm prospective clinical trial designed to evaluate the efficacy of Shatavari Ghrita in the management of Vibandha (functional constipation) in Children aged 5-10 years.Vibandha though not described as a seperate disease in Ayurveda,is explained through altered bowel functions due to Apana Vayu vitiation,Agnimandya,and Purishavaha Srotas Dushti and correlates with functional constipation described in modern medicine.Children diagnosed with functional constipation based on Rome IV criteria will receive oral Shatavari Ghrita for 14 days with assessment at baseline,Day 8,Day 15,Day 29.The primary outcomes include improvement in frequency of bowel movements,stool consistency,and nature of evacuation,while secondary outcome will be improvement in the lifestyle of children as per parent feedback after 14 days of intervention from baseline.The study aims to scientifically validate the traditional Ayurvedic use of Shatavari Ghrita as a safe and effective option for pediatric population with functional constipation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children of age group 5 to 10 years.
- •Parents who are ready to recruit their children in the trial and sign the informed consent form.
- •Participants fulfilling the Rome IV criteria.
Exclusion Criteria
- •Subjects with Hirschsprung’s disease, Hypothyroidism, Cerebral Palsy, Neurological disorders, Spinal cord abnormalities, Celiac disease, Anal stenosis, Anorectal malformation.
- •Subjects with ongoing acute illness and Gastrointestinal infections like Diarrhea, Amoebiasis, Worm infestations.
- •Subjects on Chronic laxative therapy, Steroids, Anticholinergics, or any medication known to cause Constipation.
- •Subjects with Psychiatric illness, Developmental Delay that may affect compliance.
Investigators
Dr Dinesh Kumar
Amrita School of Ayurveda