Clinical trails in subjects with bacterial infection.

A prospective, randomized, open label, comparative study to evaluate the safety and efficacy of Gotu Kola with Apple formulation for its efficacy in improving immunity, anti-oxidant levels and overall improvement in general wellbeing in subjects with bacterial infection.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049817

Enrollment

Registered

2023-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: J069- Acute upper respiratory infection,unspecified

Interventions

Intervention1: Standard of Care and Mulmina Apple: Along with standard of care Mulmina Apple juice Dosage form: Liquid dose: 3 packs/day frequency route of administration : Orally total duration : 2

Eligibility

Inclusion criteria

Inclusion criteria: 1. Volunteer aged between 18 to 60 years (both inclusive) 2. Subjects with Upper Respiratory Tract Infection (URTI)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
1. Less number (% change) of clinical deteriorations (defined as a significant change in clinical status /hospitalization). 2. Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. 4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. 3.Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. 4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. 3. Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. 4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. Timepoint: Day 0 to Day 14	—

Measure

Time frame

1. Less number (% change) of clinical deteriorations (defined as a significant change in clinical status /hospitalization). 2. Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. 4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. 3.Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. 4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. 3. Significant change in the clinical symptoms in Groups receiving SOC along with Mulmina Apple. 4.Significant change in cortisol in Groups receiving SOC along with Mulmina Apple. Timepoint: Day 0 to Day 14

—

Secondary

Measure	Time frame
1. Safety aspects in the Groups receiving Mulmina Apple along with SOCTimepoint: Day 0 to Day 14	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt. Ltd

ashok@radiantresearch.in9880999297

Outcome results

None listed

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