Table 1.
Results of Delphi Consensus-Round 1
|
Item |
Compiled Responses |
Participant Comments |
||
| Yes |
No |
Un certain |
||
| 1. The genus of the test NP was stated. | 9 | - | 2 | • Items 1 & 2 assume an organism is used, but there are many chemical NPs, so we need to include an unambiguous name if it is a natural chemical e.g. arginine is ambiguous, L-arginine is correct. |
| 2. The species of the test NP was stated. | 9 | - | 1 | • Need to be more specific by listing cultivars/varieties |
| 3. The plant part used to prepare the test NP was stated. | 10 | - | 1 | • Also when and where harvested |
| 4. How the test NP was processed/extracted was described. |
9 |
1 |
- |
• Chemistry and manufacturing information is required by the NP Regulations • Proprietary data but for government registration should be included but should not be reported in the publication |
| 5. If test NP was a commercial product, brand name was stated. |
8 |
1 |
1 |
• Interesting, but not essential. • Brand is important because of differences in manufacturing. |
| 6. If test NP was a commercial product, the name of the manufacturer was stated. | 9 | 1 | - | |
| 7. If test NP was a commercial product, the lot number was stated. | 8 | 2 | - | • Make sure they have enough supply for the complete trial and didn't use different lots throughout study |
| 8. The name of important chemical(s)of the test NP was stated. |
11 |
- |
- |
• The term "important chemicals" is vague • Full characterization or fingerprinting of the testing material • This could be a problem with some products as active agent(s) may not be known • Should have a percentage of the chemicals present listed • If standardized for the chemical content and the manufacturer wants to be public |
| 9. The amount of important chemical(s) of the test NP was stated. |
11 |
- |
- |
• The term "important chemicals" is vague • If the makers are not active compounds, there is no need to quantify each compound but it is always good to have some quantitative information |
| 10. The test NP was analyzed for chemical content. | 11 | - | - | • For registration with to government yes but should be agreed upon by investigator and company before publication. |
| 11. The dosage form of the test NP was stated. | 10 | - | - | |
| 12. The dose of the test NP was stated. | 10 | - | - | |
| 13. The frequency of administration of the test NP was stated. | 10 | - | - | |
| 14. The route of administration of the test NP was stated. | 10 | - | - | |
| 15. The placebo or comparison treatment and the test NP were matched in terms of taste, smell, appearance and dosing regimens. | 10 | - | - | |
| 16. The success of blinding was evaluated. | 10 | - | - | |