Whether an ayurvedic drug preparation named Ap-Bio/Kalmcold is safe and effective when used to treat participants diagnosed with common cold and have no other complications

Efficacy and safety of Ap-Bio/Kalmcold in participants with uncomplicated upper respiratory tract viral infection (common cold) - A Phase III, double-blind, parallel group, randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021754

Enrollment

300

Registered

2019-10-22

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: Ap-Bio/Kalmcold (low dose): 100 mg twice daily orally after food for 7 days Intervention2: Ap-Bio/Kalmcold (moderate dose): 200mg twice daily orally after food for 7 days Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consenting adults of any gender 18 - 60 years of age 2. Diagnosis of uncomplicated upper respiratory tract viral infection, onset of symptoms within 48 hours of randomization. 3. Not participated in any other interventional trials in the last 1 month before randomization 4. Participants with moderate to severe symptoms

Exclusion criteria

Exclusion criteria: 1. Women of reproductive age who are pregnant / lactating / not willing for adequate contraception 2. History of allergy to any medications including alternate system of medications 3. Inability to follow-the protocol or expressed inability to complete all follow-ups 4. History of allergic rhinitis, asthma, serious ailments of the heart. Liver or kidney, malignancies and any immunological disorders 5. History of any concomitant or chronic conditions involving the respiratory tract like bacterial pharyngitis, lower respiratory tract infections, Chronic obstructive pulmonary disease, interstitial lung disease, sinusitis etc. 6. Past history of Tuberculosis 7. User of any form of Tobacco everyday 8. Participants on medications / require any of the following medications â?? Antibiotics, Anti-viral agents, Anti-histaminics, Steroids, Decongestants, Herbal remedies, Vitamin C or Zinc

Design outcomes

Primary

Measure	Time frame
Severity symptom score assessed by WURSS-21Timepoint: at baseline, 6 hours, days 2,3,5 & 7	—

Secondary

Measure	Time frame
Adverse EventTimepoint: through out the study;C reactive protein, WBC, nasal mucociliary function test, IL-8 & IgA in nasal washTimepoint: Baseline and day 3;Nasal mucosal weight and tissue paper countTimepoint: Days 1, 2 and 3;Visual Analogue Score of symptoms (Cough , Expectoration , Nasal discharge , Headache , Fever Sore throat, Earache, Malaise/ Fatigue, Sleep disturbance ) From 0 to 100 : 0 being least and 100 being worstTimepoint: at baseline, 6 hours, and twice daily afterwards till day 7	—

Measure

Time frame

Adverse EventTimepoint: through out the study;C reactive protein, WBC, nasal mucociliary function test, IL-8 & IgA in nasal washTimepoint: Baseline and day 3;Nasal mucosal weight and tissue paper countTimepoint: Days 1, 2 and 3;Visual Analogue Score of symptoms (Cough , Expectoration , Nasal discharge , Headache , Fever Sore throat, Earache, Malaise/ Fatigue, Sleep disturbance ) From 0 to 100 : 0 being least and 100 being worstTimepoint: at baseline, 6 hours, and twice daily afterwards till day 7

—

Countries

India

Contacts

Public ContactJeffrey Pradeep Raj

Seth GSMC & KEM Hospital

jpraj.m07@gmail.com07904286189

Outcome results

None listed

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