This clinical trial was conducted for eight weeks, and three groups each including 40 people participated in it. The first follow-up was done in person, but the next one was done by phone due to the escalation of the corona pandemic. During this follow-up, a number of participants were unwilling to cooperate due to having coronary heart diseases; therefore, they stepped out of the project. In total, there remained 31 people in the N. sativa group. In the placebo group and the gabapentin group, 11 and 27 people took part in the analysis (Fig. 1). There were no side effects observed in any of the three groups.
These three groups were not significantly different in terms of age (P-value: 0695), MNSI score (P-value: 0167) and HbA1c (P-value: 0.865). (Table1)
Table 1
Age and score variables and HbA1c values reported as mean (± SD) a content (percentage)
variable | N. sativa | Placebo | Gabapentin | P-value |
Age | 64.94 (± 9.487) | 62.09 (± 8.596) | 63.30 (± 11.874) | 0.695 |
MNSI score | 6.03226 (± 1.657988) | 5.59091 (± 1.594023) | 5.18519 (± 1.732873) | 0.167 |
Hba1c | 7.5412 (± 1.46717) | 7.7714 (± 1.85447) | 7.4059 (± 1.42059) | 0.865 |
The results of the study were obtained based on the participants’ answers in the Michigan questionnaire before and after taking each of the drugs, i.e., gabapentin, placebo and N. sativa ointment, as well as the corresponding statistical comparisons. The main results are provided below.
There were reports of numbness and tingling sensation in the legs and feet in the groups taking the N. sativa (P-value: 0.00), placebo (P-value: .0341) and gabapentin (P-value: 0.003), prinking feeling in feet or legs in N. sativa ointment (P-value: 0.00), placebo (P-value: 0.15) and in Gabapentin group (P-value: 0.001). Also, the aggravation of symptoms at night was reduced in N. sativa (P-value: 0.00), placebo (P-value: 0.74) and gabapentin (P-value: .001) groups, but the reduction was significant in the N. sativa group with the gabapentin group next to it.
The patients in all the groups felt uncomfortable with bed sheets stretched on their feet, with P-values of 0.00, 0.153 and .001 for the N. sativa, placebo and gabapentin groups, respectively. Moreover, feeling uneasy when walking was reported by the groups that took the N. sativa (P-value: 0.0327), placebo (P-value:1) and gabapentin (P-value: 0.613). In both cases, only the group consuming N. sativa experienced a significant decrease of the adverse feelings.
Muscle cramps in the groups taking the N. sativa (P-value: 0.00), placebo (P-value: 0.00) and gabapentin (P-value: .0.00) reduced significantly, so did burning sensation in the legs with P-values of 0.00, 0.00 and 0.00 for the N. sativa, placebo and gabapentin groups respectively. However, the reduction in muscle cramps after using N. sativa was significantly more than that in the other two groups
However, in the study of the participants' answers to the question about the recognition of cold and hot water when showering, there was no statistically significant difference among the N. sativa, placebo and gabapentin groups, with the P-values of 0.326, 1 and 0.83, respectively (Table 2).
Table 2
Analytical results for the answers to a number of Michigan questionnaire items before and after using N. sativa, placebo and gabapentin: The values are reported as means (± SD) and P-values.
Question | N. sativa | P-value of N. sativa | placebo | P-value of Placebo | gabapentin | P-value of gabapentin |
Legs and feet numb | After | 77.42 (± 42.502) | 0.00 | 45.45 (± 52.223) | 0.341 | 70.37 (± 46.532) | .003 |
Before | 42.58 (± 33.113) | 43.64 (± 50.452) | 57.78 (± 42.161) |
Burning pain in feet or legs | After | 96.77 (± 17.961) | 0.00 | 100.00 (± .00) | .001 | 92.59 (± 26.688) | .00 |
Before | 49.84 (± 28.240 | 75.00 (± 18.574) | 65.37 (± 36.740) |
Get muscle cramps in feet or legs | After | 60.00 (± 50.00) | 0.00 | 100.00 (± .00) | .000 | 66.67 (± 48.154) | .000 |
Before | 9.00 (± 20.666) | 36.00 (± 36.803) | 13.54 (± 24.069) |
Prickling feeling in feet or legs | After | 87.10 (± 34.078) | .00 | 81.82 (± 40.452) | .153 | 81.48 (± 39.585) | 0.001 |
Before | 40.65 (± 32.320) | 67.73 (± 44.574) | 56.30 (± 41.501) |
It hurts when the bed covers touch the skin. | After | 40.00 (± 49.827) | .005 | 44.44 (± 52.705) | .300 | 38.46 (± 49.614) | 0. 0.078 |
Before | 19.67 (± 35.693) | 38.33 (± 47.828) | 30.38 (± 43.930) |
Able to tell the hot water from the cold water | After | 3.45 (± 18.570) | 0.326 | 0.00 (± .000) | 1 | 11.11 (± 32.026) | 0.83 |
Before | 0.69 (± 3.714) | 0.00 (± 0.00) | 1.11 (± 3.20300) |
Symptoms worse at night | After | 80.00 (± 40.684) | .000 | 63.64 (± 50.452) | 0.74 | 70.37 (± 46.532) | 0.001 |
Before | 27.17 (29.789) | 45.91(± 44.655) | 44.26 (± 42.124) |
Walking hurts the legs. | After | 36.67 (± 49.013) | .004 | 00.00 (± 0.00) | 1 | 53.85 (± 50.839) | 0.45 |
Before | 23.33 (± 34.699) | 0.00 (± .00) | 50.00 (± 47.979) |
Feeling the feet when walking | After | 3.85 (± 19.612) | .0327 | .00 (± .00) | 1 | 8.00 (± 27.689) | 1 |
before | 1.54 (± 7.845) | .00 (± .00) | 8.00 (± 27.689) |