|
13. Interventions
|
|
13.1 Intervention name
|
129 (100.0%)
|
7 (100.0%)
|
136 (100.0%)
|
|
13.2 Ingredients or detail technique
|
13 (10.1%)
|
1 (14.3%)
|
14 (10.3%)
|
|
13.3 Form
|
55 (42.6%)
|
4 (57.1%)
|
59 (43.4%)
|
|
13.4 Dosage and frequency
|
20 (15.5%)
|
4 (57.1%)
|
24 (17.6%)
|
|
13.5 Treatment duration
|
6 (4.7%)
|
0 (0.0%)
|
6 (4.4%)
|
|
13.6 Control group
|
103 (79.8%)
|
7 (100.0%)
|
110 (80.9%)
|
|
Total average
|
54.3 (42.1%)
|
3.8 (54.8%)
|
58.1 (42.7%)
|
|
14. Key inclusion and exclusion criteria
|
|
14.1 Criteria of inclusion and exclusion
|
129 (100.0%)
|
7 (100.0%)
|
136 (100.0%)
|
|
14.2 Gender
|
129 (100.0%)
|
7 (100.0%)
|
136 (100.0%)
|
|
14.3 Age
|
109 (84.5%)
|
7 (100.0%)
|
116 (85.3%)
|
|
14.4 Diagnosis criteria—Western medicine
|
45 (34.9%)
|
2 (28.6%)
|
47 (34.6%)
|
|
14.5 With healthy human volunteer
|
1 (0.8%)
|
0 (0.0%)
|
1 (0.7%)
|
|
Total average
|
82.6 (64.0%)
|
4.6 (65.7%)
|
87.2 (64.1%)
|
|
15. Study type
|
|
15.1 Type of study
|
129 (100.0%)
|
7 (100.0%)
|
136 (100.0%)
|
|
15.2 Method of allocation (randomized/non-randomized)
|
107 (82.9%)
|
5 (71.4%)
|
112 (82.4%)
|
|
15.3 Masking (is masking used and, if so, who is masked)
|
46 (35.7%)
|
2 (28.6%)
|
48 (35.3%)
|
|
15.4 Assignment (single arm, parallel, crossover, or factorial)
|
107 (82.9%)
|
7 (100.0%)
|
114 (83.8%)
|
|
15.5 Allocation concealment mechanism
|
6 (4.7%)
|
0 (0.0%)
|
6 (4.4%)
|
|
15.6 Phase (if applicable)
|
79 (61.2%)
|
5 (71.4%)
|
84 (61.8%)
|
|
Total average
|
79.0 (61.2%)
|
4.3 (61.9%)
|
83.3 (61.3%)
|
|
19. Primary outcome(s)
|
|
19.1 Name
|
128 (99.2%)
|
7 (100.0%)
|
135 (99.3%)
|
|
19.2 Measurement of primary outcome(s)
|
2 (1.6%)
|
0 (0.0%)
|
2 (1.5%)
|
|
19.3 Time point of measurements
|
17 (13.2%)
|
1 (14.3%)
|
18 (13.2%)
|
|
Total average
|
49.0 (38.0%)
|
2.7 (38.1%)
|
51.7 (38.0%)
|
|
20. Key secondary outcome(s)
|
|
20.1 Name
|
89 (69.0%)
|
7 (85.7%)
|
96 (70.6%)
|
|
20.2 Measurements of key secondary outcomes
|
2 (1.6%)
|
0 (0.0%)
|
2 (1.5%)
|
|
20.3 Time point of measurements
|
15 (11.6%)
|
1 (14.3%)
|
16 (11.8%)
|
|
Total average
|
35.3 (27.4%)
|
2.7 (38.1%)
|
38.0 (27.9%)
|
|
21. Ethics review
|
|
21.1 Ethics review status
|
125 (96.9%)
|
6 (83.3%)
|
131 (96.3%)
|
|
21.2 Date of approval
|
98 (76.0%)
|
4 (69.0%)
|
102 (75.0%)
|
|
21.3 Name of ethics committee(s)
|
105 (81.4%)
|
4 (78.6%)
|
109 (80.1%)
|
|
21.4 Contact details of ethics committee(s)
|
104 (80.6%)
|
0 (40.5%)
|
104 (76.4%)
|
|
Total average
|
108.0 (83.7%)
|
4.0 (57.1%)
|
112.0 (82.4%)
|
|
23. Summary results
|
|
23.1 Date of posting of result summaries
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.2 Date of the first journal publication of results
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.3 URL hyperlink(s) related to results or a full reference list of publications
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.4 Baseline characteristics
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.5 Participant flow, adverse events
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.6 Adverse events
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.7 Outcome measures
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
23.8 URL link to protocol file(s) with version and date
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
Changes to protocol
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
Total average
|
0 (0%)
|
0 (0%)
|
0 (0%)
|
|
Total special items average report percentage (%)
|
45.6%
|
45.1%
|
45.6%
|
