Randomized Controlled Trial to evaluate the efficacy of Draksha syrup in Vibandha in children ( 2-6 years) with reference to Functional Constipation.

Randomized Controlled Trial to evaluate the efficacy of Draksha syrup in Vibandha in children ( 2-6 years) with reference to Functional Constipation. - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/096758

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient age group 2-6 years irrespective of sex, religion and economical status 2.Children fulfilling the ROM III criteria30 or patient presenting sign and symptoms of vibandha. 3.Parents/ Guardians of the child willing to participate in clinical trial/study with written consent.

Exclusion criteria

Exclusion criteria: 1. Patients having Constipation due to severe illness related to Anorectal Conditions and organic disorders like Hirschsprung disease. 2. Patients with Rectal Prolapse, IBD, Malignancy, endocrinal disease etc or any other systemic illness. 3. Patient on any other long-term medications. 4. Patient known case of Neuromuscular disease like cerebral palsy

Design outcomes

Primary

Measure	Time frame
DRAKSHA SYRUP is effective in Vibhandha in children within 7 days That is, the main efficacy outcome used for sample size estimation is the mean change in spontaneous bowel movements per week from baseline to day 7.Timepoint: Follow up will be done on 0 , 3 and 7 day and outcome will be recorded.	—

Secondary

Measure	Time frame
LACTULOSE SYRUP is effective in Vibhandha in childrenTimepoint: Patient will be assessed on 0, 3 & 7 th day	—

Countries

India

Contacts

Public ContactDr Ravindra Dhanwade

PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON

dhanwaderavi7@gmail.com7620055444

Outcome results