Post marketing surveillance (PMS)study of Ascorbic acid (Vitamin C) and Zinc effervescent tablets

A Multicentric, Prospective, Observational, post Marketing surveillance study to evaluate safety of fixed dose combination of Vitamin C 1000mg + Zinc(in form of 32mg Zinc citrate trihydrate) 10mg effervescent tablet in clinical practice for treatment of Indian patients with vitamin C and zinc deficiency.

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/02/049970

Enrollment

358

Registered

2023-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Ascorbic acid and zinc effervescent tablet: Generic name: Ascorbic acid and zinc effervescent tablets Duration: 3 months Dose: 01 tablet daily Control Intervention1: not applicable: not

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male and female with Age more than 18 year. 2)Vitamin C and zinc deficiency (based on independent clinical judgment of treating physician)3) Patients that requires treatment with Ascorbic acid and zinc tablets (as determined by treating physician) 4) Patients who provide informed consent

Exclusion criteria

Exclusion criteria: 1) participation in another study 2) Presenting a risk of not being able to be followed. 3) Hypersensitivity to Ascorbic acid and zinc tablets

Design outcomes

Primary

Measure	Time frame
1. Demographics data of patients require Ascorbic acid and zinc therapy.2. Well being through out duration of study 3. Risk benefit analysis based on active survillenceTimepoint: at baseline, 4th week, 8th week and 12 week (completion of treatment)	—

Secondary

Measure	Time frame
To better understand the effectiveness and tolerability of therapyTimepoint: 12 weeks treatment	—

Countries

India

Contacts

Public ContactMs Ruchika swami

Sr Manager- Clinical operations at KHPL Delhi

Ruchika.swami@kusm.com7428196764

Outcome results

None listed

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