Evaluation of the comparative efficacy of Polyherbal syrup versus Ondansetron syrup in the management of Chhardi(vomiting) in children: A Randomized Controlled Trial
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of Polyherbal Syrup in the management of chhardi in children of age 1 year to 18 years with objective and subjective criteria
Overview
Brief Summary
The volunteers will be informed about the study protocol. Willing participants will be randomly selected from per computer-generated table. The clinical research format will be prepared and validated. Before the study approval is taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomized, double-blind, equivalence Clinical Trial. Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and 14th day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Written informed Consent and ascent will be obtain 2)Age 1 year to 18 years 3)3 or more than 3 episodes of vomiting in 24 hours 4)Mild to moderate dehydration 5)Associated diarrhea patients will also be included.
Exclusion Criteria
- •Moderate to Severe infection and dehydration or shock 2)Any Chronic systemic illness 3)Antiemetic use in the past 24 hours 4)Allergy to any formulation ingredient 5)Fever more than 100 degree fahrenheit 6)Abuse, poison or suspicious case 7)Congenital anomalies and Metabolic syndrome 8)Participants did not receive the Antihelminthic drug.
Outcomes
Primary Outcomes
To assess the efficacy of Polyherbal Syrup in the management of chhardi in children of age 1 year to 18 years with objective and subjective criteria
Time Frame: Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and | 14th day
Secondary Outcomes
- To assess the efficacy of Ondansetron Syrup in the management of chhardi in children with objective and subjective criteria.(Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and)
Investigators
DR DHANANJAY BHAGWAN MORE
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha