Trial Outcomes & Findings for Homeopathic Treatment of Post-acute COVID-19 Syndrome (NCT NCT05104749)
NCT ID: NCT05104749
Last Updated: 2023-11-22
Results Overview
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates "normal" (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Baseline, 4, 8 and 12 weeks
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
Homeopathic Treatment Group
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Homeopathic Treatment Group
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Homeopathic Treatment of Post-acute COVID-19 Syndrome
Baseline characteristics by cohort
| Measure |
Homeopathic Treatment Group
n=38 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=39 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education Status
High School
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education Status
Some college
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Education Status
Bachelor's Degree
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Education Status
Master's Degree
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education Status
PhD or higher
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI
|
27.6 kg/m^2
STANDARD_DEVIATION 7.8 • n=5 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Duration of Long Covid Symptoms
|
246.4 Days
STANDARD_DEVIATION 141.0 • n=5 Participants
|
285.5 Days
STANDARD_DEVIATION 151.1 • n=7 Participants
|
266.2 Days
STANDARD_DEVIATION 146.6 • n=5 Participants
|
|
Hospitalization Rate for Acute Covid-19 Infection
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number of Vaccinated Participants
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Number of Long Covid Booster Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Number of Medications
Zero
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Number of Medications
1-2
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Number of Medications
3 or more
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Number of Supplements
Zero
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Number of Supplements
1-4
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Number of Supplements
5 or more
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Baseline Score in Fatigue Assessment Scale
|
34.4 score on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
35.8 score on a scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
35.1 score on a scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Baseline Score in SF-36 Physical Composite Score (PCS)
|
45.8 score on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
|
42.9 score on a scale
STANDARD_DEVIATION 20.4 • n=7 Participants
|
44.3 score on a scale
STANDARD_DEVIATION 18.9 • n=5 Participants
|
|
Baseline Score in SF-36 Mental Combined score (MCS)
|
35.7 score on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
37.6 score on a scale
STANDARD_DEVIATION 16.7 • n=7 Participants
|
36.6 score on a scale
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
Baseline Score in PHQ-9
|
12.8 score on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
10.8 score on a scale
STANDARD_DEVIATION 5.1 • n=7 Participants
|
11.8 score on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Baseline Score in MYMOP Symptom #1
|
4.6 score on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.5 score on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
4.5 score on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Baseline Score in MYMOP Symptom #2
|
4.4 score on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4, 8 and 12 weeksPopulation: All patients under randomization were included (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates "normal" (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018).
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Fatigue Assessment Scale (FAS)
8 Weeks
|
29.0 score on a scale
Standard Deviation 8.0
|
27.4 score on a scale
Standard Deviation 9.4
|
|
Fatigue Assessment Scale (FAS)
4 Weeks
|
32.9 score on a scale
Standard Deviation 7.6
|
31.4 score on a scale
Standard Deviation 7.7
|
|
Fatigue Assessment Scale (FAS)
12 Weeks
|
29.4 score on a scale
Standard Deviation 9.1
|
27.3 score on a scale
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: Baseline and 4, 8, and 12 weeksQuality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores.
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
SF-36 Physical Composite Score (PCS)
4 Weeks
|
51.8 score on a scale
Standard Deviation 18.2
|
51.1 score on a scale
Standard Deviation 22.3
|
|
SF-36 Physical Composite Score (PCS)
8 Weeks
|
55.0 score on a scale
Standard Deviation 22.6
|
58.7 score on a scale
Standard Deviation 26.5
|
|
SF-36 Physical Composite Score (PCS)
12 Weeks
|
55.0 score on a scale
Standard Deviation 23.1
|
61.2 score on a scale
Standard Deviation 27.4
|
PRIMARY outcome
Timeframe: Baseline and 4, 8, and 12 weeksQuality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores. 
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
SF-36 Mental Composite Score (MCS)
Week 4
|
43.0 score on a scale
Standard Deviation 21.6
|
50.2 score on a scale
Standard Deviation 21.7
|
|
SF-36 Mental Composite Score (MCS)
Week 8
|
47.8 score on a scale
Standard Deviation 22.0
|
54.7 score on a scale
Standard Deviation 24.8
|
|
SF-36 Mental Composite Score (MCS)
Week 12
|
49.8 score on a scale
Standard Deviation 23.4
|
57.3 score on a scale
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool for assessing depression The PHQ-9 scores each of the 9 DSM-IV depression criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores range from 0 to 27, with scores of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression, respectively.
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
7.8 score on a scale
Standard Deviation 5.7
|
6.8 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health.
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Measure Yourself Medical Outcomes Profile Symptom #1
|
1.3 score on a scale
Standard Deviation 1.9
|
1.6 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health.
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Measure Yourself Medical Outcomes Profile Symptom #2
|
1.0 score on a scale
Standard Deviation 1.7
|
1.7 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 12 weeksThe Patient Doctor Depth of Relationship (PDDR) scale is an eight item, patient self-completed questionnaire designed to measure patient-doctor relational depth. A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship).
Outcome measures
| Measure |
Homeopathic Treatment Group
n=36 Participants
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=36 Participants
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Patient Doctor Depth of Relationship (PDDR)
|
24.1 score on a scale
Standard Deviation 6.4
|
24.3 score on a scale
Standard Deviation 6.1
|
Adverse Events
Homeopathic Treatment Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Group
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Homeopathic Treatment Group
n=38 participants at risk
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=39 participants at risk
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/38 • During study duration (12 weeks).
|
2.6%
1/39 • Number of events 1 • During study duration (12 weeks).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/38 • During study duration (12 weeks).
|
2.6%
1/39 • Number of events 1 • During study duration (12 weeks).
|
Other adverse events
| Measure |
Homeopathic Treatment Group
n=38 participants at risk
Long Covid patients received individualized homeopathic treatment with homeopathic medicines. Dosage and frequency of administration was determined by each provider on an individualized basis.
|
Placebo Group
n=39 participants at risk
Long Covid patients received placebo homeopathic medicines (i.e. identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines)
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/38 • During study duration (12 weeks).
|
2.6%
1/39 • Number of events 1 • During study duration (12 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/38 • During study duration (12 weeks).
|
2.6%
1/39 • Number of events 1 • During study duration (12 weeks).
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.6%
1/38 • Number of events 1 • During study duration (12 weeks).
|
2.6%
1/39 • Number of events 1 • During study duration (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.6%
1/38 • Number of events 1 • During study duration (12 weeks).
|
0.00%
0/39 • During study duration (12 weeks).
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Number of events 1 • During study duration (12 weeks).
|
0.00%
0/39 • During study duration (12 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/38 • During study duration (12 weeks).
|
2.6%
1/39 • Number of events 1 • During study duration (12 weeks).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
1/38 • Number of events 1 • During study duration (12 weeks).
|
5.1%
2/39 • Number of events 2 • During study duration (12 weeks).
|
|
Immune system disorders
Vaccine Injury
|
2.6%
1/38 • Number of events 1 • During study duration (12 weeks).
|
0.00%
0/39 • During study duration (12 weeks).
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/38 • Number of events 1 • During study duration (12 weeks).
|
0.00%
0/39 • During study duration (12 weeks).
|
Additional Information
Elizabeth Rice Principal Investigator
Sonoran University of Health Sciences
Phone: 4809700000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place