An open label Randomized placebo controlled clinical trial on Saindhavadi Yoga in the management of Vibandha W.S.R. to Functional Constipation in Children.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- State ayurvedic college and hospital Lucknow
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To improve the quality of life in Children suffering from functional constipation.
Overview
Brief Summary
Functional constipation is one of the lifestyle disorders.To improve the quality of life suffering from functional constipation therefore I selected this clinical trial. Clinical trial will be done on Saindhavadi yoga . Maximum 60 Functional constipation diagnosed children aged 3-12 yr clinical studies into two group of treatment modules. Each segment of the treatment module will be of 2 months after each treatment there is a gap of 15 days .Total duration of trial is 75 days. Follow up will be performed before intervention and after 15 days of each treatment module . A follow up will be done after 15 days of complete clinical trial
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children fulfilling ROME IV Criteria.
- •Most include 2 or more following occurring at least once a week.
- •for a minimum 1 month with insufficient criteria to diagnose irritable bowel syndrome.
- •Two or fewer defecations in the toilets per week in a child of a developmental age of at least 4 year
- •At least one of fecal incontinence per week.
- •History of retentive posturing or excessive volitional stool retention.
- •History of painful or hard bowel movement.
- •Presence of a large fecal mass in the rectum.
- •History of large diameter stool that can obstruct the toilets after appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
Exclusion Criteria
- •Children with organic disorders as Hischsprung disease should be excluded.
- •Children Suffering from liver disorders should be excluded.
- •Children suffered with other systemic illness like T.B. HIV should be excluded.
- •Drug induced constipation should be excluded (drugs such as opiates, anticholinergic agents, phenobarbitone, vincristine and lead).
- •5.Children not fulfilling the criteria of Rome IV.
Outcomes
Primary Outcomes
To improve the quality of life in Children suffering from functional constipation.
Time Frame: At 75th day of completing clinical trial.
Secondary Outcomes
- To assess the efficacy of saidhavadi yoga.(1st day, 15th day, 30th day, 45th day, 60th day, 75th day)
Investigators
Vanshika Dhama
state ayurvedic college and hospital Lucknow