Clinical trial on Covid 19 patients

A Multicenter Prospective, Open Label, Randomized, Clinical Study To Evaluate The Safety And Efficacy Of Cardamom-based capsules and sachets In Mild to Moderate Covid-19 Adult Patients

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/033143

Enrollment

Registered

2021-04-27

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: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Cardamom-based capsules containing Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: Dose : 500 mg Dosage form : Capsules Route of adm

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT-PCR). 4. Mild to Moderate disease (NEWS score Less than/equal to 8) 5. Can take oral medicines 6. Subject willing to abide by and comply with the study protocol

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years and more than 75 years 2. Pregnancy and lactation 3. Severe or complicated course of COVID-19 disease 4. Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. 5. Any uncontrolled systemic disease, infection 6. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. 7. 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

Primary

Measure	Time frame
1. To assess the basal level inflammatory marker expression (IL-6, TNF-Î±, IL-10) by RT-PCR in SARS-CoV -19 patients prior to treatment administration. 2.To asses the IL6,crp,D-DIMER and LDH 3. To evaluate the effectiveness of cardamom-based capsules and sachets in treating SARS CoV-2 patients Timepoint: Day 0,Day 5 and Day 10	—

Secondary

Measure	Time frame
1.Adverse events (AEs), frequency and severity at day 7 2.Number of subjects who discontinue study due to adverse events at day 7 3.Changes in vital parameters and safety laboratory parameters (liver function test, renal function test, serum electrolyte) from baseline to day 7 Timepoint: Day 0 to day 14	—

Countries

India

Contacts

Public ContactDr Prashanth Varkey

Zum Heilen Diagnostic and Therapeutics

drpvarkey@gmail.com9249584682

Outcome results

None listed

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