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clinical trial on Children With Respiratory Tract Infections

A Prospective, Randomized, Open Label Study To Evaluate The Safety And Efficacy Of Mulmina Mango Ready To Drink as A Supplement In Children With Respiratory Tract Infections

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032990
Enrollment
125
Registered
2021-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00- Acute nasopharyngitis [common cold]

Interventions

Intervention1: Mulmina Mango Ready To Drink: Dose: 200ml Dosage form: Oral Drink Frequency : 1 pack per day for 4 weeks Route of administrate : Orally Total duration: 28 days Intervention2: Azithromyc

Sponsors

Jagdale industries pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Volunteer aged between 7-14 years (both inclusive) ii. Proven to be healthy and parents willing to give written consent to participate

Exclusion criteria

Exclusion criteria: i. Children having cerebral palsy physical disability and children requiring IEP with epilepsy will be excluded from the study ii. Patients with preexisting severe systemic disease necessitating long term medication. iii. Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation. iv. Any onco neurological congenital or acquired vascular or systemic disorder which could affect any of the efficacy assessments. v. Participation in the current or previous treatment with any approved or investigational health supplements during the past 1 month.

Design outcomes

Primary

MeasureTime frame
1. Less number (% change) of clinical deteriorations (defined as a significant change in clinical status /hospitalization). 2. Safety aspects in the Groups receiving Mulmina Mango along with antibiotic(s) 3. Significant change in the clinical symptoms in Groups receiving antibiotics along with Mulmina Mango. 4. Significant change in the biomarkers in Groups receiving antibiotics along with Mulmina Mango. Timepoint: Day 0, 7 and 28

Secondary

MeasureTime frame
General health and Adverse eventsTimepoint: Day 0 to Day 28

Countries

India

Contacts

Public ContactMr Raghavendra K V

Radiant Research Services Pvt. Ltd

ashok@radiantresearch.in9880999297

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026