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Clinical trial on Covid patients with mild to moderate symptoms

: A Prospective, Open Label, Randomized, Controlled, Clinical Study To Evaluate The Safety And Efficacy Of Cardamom Extract (500mg tablet) In Mild To Modrate Covid-19 Adult Patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039852
Enrollment
200
Registered
2022-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Recovereez Forte 500mg tablet containing Cardamom Extract 200mg,Rosemary Extract 200mg, Pepper extract 10mg and Excipients: Dose:500 mg Dosage form: tablets Duration: Day 0 to Day 10 F

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
1.Improvement in the clinical features from baseline to end of the study period 2.Change in immune markers (IL6, IL10 and TNF-alpha) from baseline to Day 5 and Day 10 Timepoint: Day 0,Day 5 and Day 10

Secondary

MeasureTime frame
1.Adverse events (AEs), frequency and severity 2.Number of subjects who discontinue study due to adverse events Timepoint: Day 0 to Day 10

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