Clinical trails in subjects with bacterial infection.
Phase 2
Completed
- Conditions
- Health Condition 1: J069- Acute upper respiratory infection,unspecified
- Registration Number
- CTRI/2023/02/049817
- Lead Sponsor
- JAGDALE INDUSTRIES PVT. LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Volunteer aged between 18 to 60 years (both inclusive)
2. Subjects with Upper Respiratory Tract Infection (URTI)
Exclusion Criteria
1. Patients with pre-existing severe systemic disease necessitating long-term medication
2. Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation.
3. Any oncology, neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
4. Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Less number (% change) of clinical deteriorations (defined as a significant change in clinical status /hospitalization). <br/ ><br>2. Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. <br/ ><br>4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. <br/ ><br>3.Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. <br/ ><br>4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. <br/ ><br>3. Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. <br/ ><br>4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. <br/ ><br>Timepoint: Day 0 to Day 14 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Safety aspects in the Groups receiving Mulmina Apple along with SOCTimepoint: Day 0 to Day 14