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A clinical trial of a new product to understand the effectiveness and safety to manage the symptoms of covid positive adult patients.

A Double Blind, Single Centric, Randomized, Placebo controlled study to demonstrate the efficacy and safety of Omshree Savier/ Omshreeraj (test products) compared to placebo to manage mild to moderate to severe symptoms of covid infections in subjects who are diagnosed as covid positive.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029902
Enrollment
80
Registered
2020-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: OMSHREE SAVIER / OMSHREERAJ : 2 capsules 2 times a day and 1 teaspoon granules 4 times a day. Control Intervention1: Placebo: 2 capsules 2 times a day and 1 teaspoon granules 4 times

Sponsors

Omshree Sidha Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients between 18 years and 65 years old, both men or women. 2. Subject with confirmed mild to moderate to severe COVID-19 in less than 5 days, preferably who has a history of Asthma, Pneumonia, Heart disease or Diabetic and who meets any of the following criteria: a. Respiratory distress, RR � 30 times/min b. In resting state, finger oxygen saturation (SpO2) �93% c. X-ray of chest showing evidence of pulmonary infiltrates. 3. The informed consent signed. 4. Subjects willing to comply with the study Protocol.

Exclusion criteria

Exclusion criteria: 1. Creatinine level is less than 1.10. 2. History of severe liver or kidney diseases. 3. History of any malignancies. 4. Subjects who are hypersensitive to herbal medications. 5. Subjects who are participating in any other trial within 30 days prior to consent. 6. Pregnant or lactating women. 7. Any other circumstances that the investigator considers inappropriate for the participation in this study. 8. Subjects who are unwilling to follow the study plan. 9. Any condition which subject may have which can cause increase risk of bleeding.

Design outcomes

Primary

MeasureTime frame
1.Time taken to reach Covid-19 negative 2. Improvement of body temperature from baseline. 3. Time taken to reach the change in RR from baseline to Day 4 and Day 8. 4. Change in SpO2 from baseline to Day 4 and Day 8. 5. Change in chest X-ray from baseline to Day 4 and Day 8. 6. Time taken for nasal/chest symptoms to become normal from baseline. 7. Duration of oxygen therapy 8. Duration of hospitalization Timepoint: Screening, Day 0, 4 8 and 21 (in severe cases)—

Secondary

MeasureTime frame
1.Physical Examination 2.Any reports of adverse or serious adverse events during the treatment period. 3.Significant change in laboratory parameters Any abnormal vital signs.Timepoint: Screening, Day 0, 4 8 and 21 (in severe cases)—

Countries

India

Contacts

Public ContactDr Deepa Subramanian

Omshree Sidha Hospital

info@omshreeayur.com

Outcome results

None listed

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