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Clinical trial on post covid patients

A Prospective, Open Label, Randomized, Controlled, Clinical Study To Evaluate The Safety And Efficacy Of Cardamom Extract (500mg tablet) In patients who have recovered from SARS -COV 2 infection

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043655
Enrollment
100
Registered
2022-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Cardamom Extract (500mg tablet): Cardamom Extract (500mg tablet) Dosage: tablet form Duration:90 days twice daily after meal (1-0-1) Control Intervention1: standard of care recommende

Sponsors

Zum Heilen Diagnostic and Therapeutics Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. Previously positive COVID cases along with comorbidity conditions 4. Can take oral medicines 5. Subject willing to abide by and comply with the study protocol

Exclusion criteria

Exclusion criteria: 1. Patients who are tested to be COVID-19 positive, at the time of enrollment in the study. 2. Patient with previous history of serious COPD, Asthma, Bronchiectesis and Chronic Cardiac ailments 3. Pregnant and lactating women 4. Patients who are not willing to volunteer for the study. 5. Patients developing serious complications, Immuno-compromisedpatients 6. Idiosyncratic reactions, severe medicinal aggravation and requiring ventilator support or emergency surgical intervention. 7. Age less than 18 years and more than 65 years 8. Any uncontrolled systemic disease, infection 9. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. 10. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol

Design outcomes

Secondary

MeasureTime frame
1. To assess the effect on quality of life of patients recovered from covid-19 from Base line to Day 90 2. Adverse events (AEs), frequency and severity from Base line to Day 90 Timepoint: Day to Day 90

Primary

MeasureTime frame
1. To assess persistent symptoms in patients who were recovery from SARS COV 2 infection from Base line to Day 21 2. Improvement in the clinical features from baseline to end of the study period 3. Change in immune markers (IL6, IL10 and TNF-alpha) levels from baseline to Day 21 4. Subject and Investigator Assessment Long COVID Questionnaire provided by ICMR Timepoint: IL6, IL10 and TNF-alpha: Day 0 and Day 21 clinical features : Day 0 to Day 90 Subject and Investigator Assessment Long COVID Questionnaire : Day 0,Day 30,Day 6 and Day 90

Countries

India

Contacts

Public ContactDr Prashanth Varkey

Zum Heilen Diagnostic and Therapeutics Pvt. Ltd

drpvarkey@gmail.com9249584682

Outcome results

None listed

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