Proof-of-Concept Randomized Controlled Study of Cognition Effects of the Proprietary Extract Sceletium tortuosum (Zembrin) Targeting Phosphodiesterase-4 in Cognitively Healthy Subjects: Implications for Alzheimer’s Dementia
Table 4
Treatment emergent adverse events: Zembrin versus placebo.
Category
Signs/symptoms
Minimal = 1
Mild = 2
Moderate = 3
Severe = 4
Z
P
Z
P
Z
P
Z
P
Head
Headache
0
0
0
0
0
5
0
Eyes
Eye irritation
0
0
0
0
0
0
0
5
Eyes
Vision blurred
0
0
5
0
0
0
0
5
Ears
Poor hearing
5
5
0
0
0
0
0
0
Mouth
Hypersalivation
0
5
0
0
0
0
0
0
Mouth
Dental problems
0
0
0
0
5
5
0
0
Chest
Chest pain
0
0
5
0
0
0
0
0
Chest
Coughing
0
5
0
0
0
0
0
0
Gastrointestinal
GI discomfort
0
0
0
5
0
0
9.5
0
GI
Nausea
0
0
0
0
5
0
0
0
GI
Vomiting
0
0
0
0
5
0
0
0
GI
Constipation
0
0
0
0
0
0
5
0
GI
Flatulence
0
0
0
5
0
0
5
0
GI
Appetite increase
5
0
0
0
5
0
0
0
GI
Appetite decrease
0
5
0
10
0
5
0
0
GI
Weight gain
14
0
0
0
0
0
0
0
GI
Weight loss
5
10
0
15
0
0
0
0
GI
Thirst increase
0
0
5
0
5
0
0
0
GU
Increased frequency
0
0
0
5
0
5
0
0
GU
Genital discomfort
0
0
0
0
5
0
0
0
GU
Increased libido
0
0
0
0
0
5
0
0
Musculoskeletal
Muscle/bone/joint pain
5
0
0
5
0
10
0
5
MS
Rigidity (muscle)
0
0
0
0
5
0
0
0
Skin
Skin irritation
0
0
0
10
0
10
0
0
Skin
Hair problems
0
5
0
5
0
5
0
0
Psychiatric: PS
Tiredness/fatigue
0
0
5
0
0
0
5
0
PS
Overarousal
0
5
0
0
0
5
0
0
PS
Difficulty falling asleep
0
0
0
10
0
0
0
0
PS
Early morning awakenings
5
5
0
5
0
0
0
0
PS
Interrupted sleep
0
0
0
10
0
0
0
0
PS
Drowsiness
0
0
0
0
0
0
5
0
PS
Confusion
0
0
0
0
5
0
0
0
PS
Concentration difficulty
0
0
0
0
0
0
5
0
PS
Memory problems
0
5
0
0
5
0
0
0
PS
Depression
0
0
0
0
5
0
0
0
PS
Anxiety
0
5
0
0
5
0
0
0
PS
Irritability
0
0
0
5
0
0
0
0
NB: no life-threatening adverse events were found. Frequency of adverse events ≥5%. Z: Zembrin treated group. P: placebo treated group.
