A Comparative Clinical Study on Lodhradi Churna and Balchaturbhadra Churna in the management of Balatisara in Children
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Improvement in abdominal pain.
Study Overview
Brief Summary
In this research evaluate the efficacy of Lodhradi Churna and Balchaturbhadra Churna in children diarrhoea. Trial drug will be given in 2 group. This research is double blind randomised parallel group comparative study. Maximum 40 subjects will be taken aged between 2 to 10 years. In first group Lodhradi syrup will be given and in second group Balchaturbhadra syrup will be given orally. The total duration of trial is 15 days and follow up will be done at 3rd, 5th, 7th, and 15th day.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Double
Eligibility Criteria
- Ages
- 2.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patients having age between 2 year to 10 years.
- •2 Patients lying under diagnostic criteria.
- •3 Patients having mild degree of dehydration.
- •4 Patients/parents who are willing to participate in trial.
- •5 Patients having loose and watery stool within 7 days.
Exclusion Criteria
- •1 Patient suffering from moderate to severe dehydration.
- •2 Severe dysentery and high grade fever.
- •3 Persistent vomiting.
- •4 Any serious life-threatening disease.
- •5 Associated with severe systemic disease.
- •6 Severe case of diarrhea.
- •7 Patients having persistent loose and watery stool more than 7 days.
Outcomes
Primary Outcomes
Improvement in abdominal pain.
Time Frame: After 15 days of complete clinical trial.
Improvement in frequency/consistency of stool.
Time Frame: After 15 days of complete clinical trial.
Improvement in condition of children.
Time Frame: After 15 days of complete clinical trial.
Secondary Outcomes
- To evaluate the efficacy of Bal chaturbhadra churna and Lodhradi churna(After completing the 15the day of trial.)
Investigators
Dr Dolly Shukla
State Ayurvedic College and Hospital, Lucknow