Trial Outcomes & Findings for Nigella Sativa in COVID-19 (NCT NCT04401202)
NCT ID: NCT04401202
Last Updated: 2021-05-26
Results Overview
The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Day 14
Results posted on
2021-05-26
Participant Flow
233 cases assessed for eligibility. 50 cases were excluded because; Asymptomatic (31), Pregnant (3), Declined to participate (n= 7), Failed communication (n= 9)
Participant milestones
| Measure |
Control
Standard of care
|
Nigella Sativa Oil
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
91
|
|
Overall Study
COMPLETED
|
86
|
87
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Control
Standard of care
|
Nigella Sativa Oil
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Hospitalized
|
4
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nigella Sativa Oil
n=87 Participants
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 Participants
Standard of care
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 10 • n=87 Participants
|
35 years
STANDARD_DEVIATION 11 • n=86 Participants
|
35 years
STANDARD_DEVIATION 11 • n=173 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=87 Participants
|
39 Participants
n=86 Participants
|
80 Participants
n=173 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=87 Participants
|
47 Participants
n=86 Participants
|
93 Participants
n=173 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 6.1 • n=87 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=86 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=173 Participants
|
|
Smoker
|
12 Participants
n=87 Participants
|
9 Participants
n=86 Participants
|
21 Participants
n=173 Participants
|
|
Pre-enrollment days
|
3.5 days
STANDARD_DEVIATION 2.1 • n=87 Participants
|
4 days
STANDARD_DEVIATION 3.1 • n=86 Participants
|
3.7 days
STANDARD_DEVIATION 2.6 • n=173 Participants
|
PRIMARY outcome
Timeframe: Day 14The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)
Outcome measures
| Measure |
Nigella Sativa Oil
n=87 Participants
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 Participants
Standard of care
|
|---|---|---|
|
Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
|
54 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 14The number of days to recovery (number of symptomatic days)
Outcome measures
| Measure |
Nigella Sativa Oil
n=87 Participants
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 Participants
Standard of care
|
|---|---|---|
|
The Number of Days to Recovery
|
11 days
Interval 8.0 to 14.0
|
14 days
Interval 11.0 to 14.0
|
SECONDARY outcome
Timeframe: Day 14Duration of each symptom in days
Outcome measures
| Measure |
Nigella Sativa Oil
n=87 Participants
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 Participants
Standard of care
|
|---|---|---|
|
Duration of Each Symptom
Anosmia
|
8.5 days
Standard Deviation 3.9
|
10.4 days
Standard Deviation 3.6
|
|
Duration of Each Symptom
Runny nose
|
2.5 days
Standard Deviation 1.6
|
3.7 days
Standard Deviation 2.5
|
|
Duration of Each Symptom
Loss of appetite
|
3.5 days
Standard Deviation 2.9
|
5.5 days
Standard Deviation 3.1
|
|
Duration of Each Symptom
Chills
|
2.1 days
Standard Deviation 1
|
4.9 days
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Day 14Side effects from the investigational treatment
Outcome measures
| Measure |
Nigella Sativa Oil
n=87 Participants
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 Participants
Standard of care
|
|---|---|---|
|
Side Effects
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14High severity of COVID-19 (mild cases does not require hospitalization)
Outcome measures
| Measure |
Nigella Sativa Oil
n=87 Participants
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 Participants
Standard of care
|
|---|---|---|
|
Hospital Admission Due to Disease Complications
|
0 Participants
|
4 Participants
|
Adverse Events
Nigella Sativa Oil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nigella Sativa Oil
n=87 participants at risk
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
|
Control
n=86 participants at risk
Standard of care
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
3.4%
3/87 • 14 days
|
0.00%
0/86 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place