| CTRI Number |
CTRI/2023/08/056064 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of beneficial effect of Bio Sun Kids sachets in children with loose stools |
|
Scientific Title of Study
|
Randomized Double Blinded Controlled Trial to Evaluate the Efficacy and Safety of BioSun Kids - In Children with Acute Diarrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Siva Sankar |
| Designation |
Resident doctor and Post Graduate |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Room no. 3, 3rd floor, Department of Pharmacology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai.
Chennai
TAMIL NADU
603103
India |
| Phone |
8754707267 |
| Fax |
|
| Email |
drsiva93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar |
| Designation |
Head of the Department, Pharmacology |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Vice principal, Head of the Department of Pharmacology, Room no. 3, 3rd floor, Department of Pharmacology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai .
Chennai
TAMIL NADU
603103
India |
| Phone |
9094752000 |
| Fax |
|
| Email |
arunrmbbs1978@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Siva Sankar |
| Designation |
Resident doctor and Post Graduate |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Room no. 3, 3rd floor, Department of Pharmacology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai.
Chennai
TAMIL NADU
603103
India |
| Phone |
8754707267 |
| Fax |
|
| Email |
drsiva93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai 603103 and
Tablets India limited, Jhaver centre 72, Marshall’s road, Chennai 600008 |
|
|
Primary Sponsor
|
| Name |
Tablets India |
| Address |
Jhaver centre 72, Marshall’s road
Chennai 603103 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Siva Sankar |
Chettinad hospital and research institute |
Room no. 19, 1st floor, Department of paediatrics, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai 603013.
Chennai
TAMIL NADU |
8754707267
drsiva93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research (CARE IHEC - 1) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio Sun Kids |
One sachet two times daily for 7 days. |
| Comparator Agent |
Placebo |
One sachet two times daily for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children of either sex aged 3months to 5 years suffering from acute diarrhea of rotaviral origin (duration < 3 days)
1. Children with the above symptoms and those excreting stool positive for rotavirus.
|
|
| ExclusionCriteria |
| Details |
1. Patients with infectious diarrhea other than rotaviral diarrhea.
2. Patients with serum sodium concentration above 155 or below 130 mmol/L.
3. Those with history of malabsorption syndromes.
4. Having respiratory infections / systemic infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Study group arm anticipated to show clinical as well as statistically significant reduction in the following –
1. Number of episodes (frequency) of diarrhea in a day
2. Mean duration of diarrhoea (in days)
3. Degree of dehydration
4. Duration & volume of oral rehydration salt [ORS] therapy
5. Duration & volume of intravenous fluid [IVF] therapy. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Duration & volume of intravenous fluid [IVF] therapy. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: To investigate the efficacy of BioSun Kids in the management of diarrhea in infants and children. PRIMARY OBJECTIVE: To evaluate the efficacy and safety of BioSun Kids on reducing the episodes(frequency) and duration and diarrhea induced by rotavirus. STUDY DESIGN: Double-blind, randomised, placebo controlled, prospective treatment study. PLACE OF STUDY: Chettinad Hospital and research institute SAMPLE SIZE CALCULATION: A sample size of the convenience of 100 infants/children, age 3 month to 5 years. STUDY GROUPS: 1. Study group: Group A: ORS + Zinc + Probiotic sachet (Bio Sun Kids) constituting Bacillus mesentericus T-OA -1 Million Lactobacillus sporogenes - 50 Million, Streptococcus Thermophilus St-21- 100 Million, Bacillus Clausii - 2 Billion will be given - twice a day after mixing in 10 ml of water for 1 week. 2. Control group: Group B: ORS + Zinc + placebo mixed in 10 ml of water for 1 week. STUDY INTERVENTION: BioSun Kids sachet which contains probiotic sachet constituting Bacillus mesentericus T-OA -1 Million Lactobacillus sporogenes - 50 Million, Streptococcus Thermophilus St-21- 100 Million, Bacillus Clausii - 2 Billion. INCLUSION CRITERIA: 1. Children of either sex aged 3months to 5 years suffering from acute diarrhea of rotaviral origin (duration < 3 days) 2. Children with the above symptoms and those excreting stool positive for rotavirus.
EXCLUSION CRITERIA: 1. Patients with infectious diarrhea other than rotaviral diarrhea. 2. Patients with serum sodium concentration above 155 or below 130 mmol/L. 3. Those with history of malabsorption syndromes. 4. Having respiratory infections / systemic infection.
METHODOLOGY: 1. All patients will be treated with WHO criteria ORS for no and some dehydration or intravenous fluid if needed, till the resolution of diarrhea and zinc 20 mg/day for 7 days. 2. Apart from this standard treatment, study group will be given probiotic (BioSun Kids) sachet twice a day after mixing in 10 ml of water for 7 days 3. The control group will be given only standard treatment of diarrhea and placebo mixed in 10 ml of water for 7 days DOSE RECOMMENDATIONS: BioSun Kids or placebo will be given in the form of ‘sachets’ in addition to rehydration therapy at a dose of 1 sachet two times daily up to 7 days. AGE GROUP: 3 months to 5 years FOLLOW UP: post 7 days of treatment completion. STUDY DURATION: 7 days OUTCOME: Study group arm anticipated to show clinical as well as statistically significant reduction in the following 1. Number of episodes (frequency) of diarrhea in a day 2. Mean duration of diarrhoea (in days) 3. Degree of dehydration 4. Duration and volume of oral rehydration salt [ORS] therapy 5. Duration and volume of intravenous fluid [IVF] therapy. |