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Cardamom Extract Clinical trial on Covid patients

A Prospective, Open Label, Randomized, Controlled, Pilot Clinical Study To Evaluate The Safety And Efficacy Of Cardamom Extract In Mild To Modrate Covid-19 Adult Patients

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030601
Enrollment
30
Registered
2021-01-20
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: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Cardamom extract: Dose:200 mg Dosage form: Capsule Duration: Day 0 to Day 7 Frequency : 3 times daily orally after meal Control Intervention1: NIL standard of care recommended by GOVt

Sponsors

Zum Heilen Diagnostic Therapeutics ZH DT
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. 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 65 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

MeasureTime frame
â?¢ Change in Chest CT severity score (CO-RADS) from baseline to day 7 â?¢ Change in Viral load from baseline to day 7 â?¢ Change in immune markers (IL-6, LDH, TNF, TLC, ALC, FERRITIN, CRP and D-DIMER) from baseline to day 7 Timepoint: Day 0 and Day 7

Secondary

MeasureTime frame
â?¢ Change in National Early Warning Score (NEWS) from baseline to day 7 â?¢ Change in clinical symptoms on 5 point ordinal scale from baseline to day 7 â?¢ Number of patients tested COVID 19 RT-PCR negative at day 7 â?¢ Number of patients requiring intensive care treatment (ICU) at day 7 â?¢ Number of patients requiring Ventilator support at day 7 Timepoint: Day 0 and Day 7

Countries

India

Contacts

Public ContactDr Prashanth

Zum Heilen Diagnostic and Therapeutics

drpvarkey@gmail.com9249584682

Outcome results

None listed

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