2.3. Procedures and treatments
This study was a pilot study conducted as 8-week, doubleblind,
placebo-controlled, randomized trial. A random list of
numbers was generated by computer. After being randomly
assigned to various treatment groups. Each participant received
one capsule of placebo or Centella asiatica extract at various
doses ranging 250, 500 and 750 mg once daily. Placebo and
Centella asiatica capsules had the same colour, texture, size and
smell.
All participants were assessed baseline data about cognitive
function, mood and quality of life and then they were assessed
cognitive performance and mood after the single administration,
1 and 2 months of treatment whereas the quality of life was
assessed after 2 months of treatment.
The code for study allocation was only broken when the last
participant completed the entire follow up. Staff involved in the
collection of the study’s endpoints was instructed to follow a
rigorous protocol and not to discuss any issues related to the use
of medication. The review of compliance with medication and
side effects was performed independently by the investigators,
who were also blinded to group allocation. Subjects were asked
to call the study center if they experienced any medical problems
during the 60-day study period. At the end of the study, they were
also asked about adverse events. Laboratory tests were drawn at
baseline and follow-up visits and compared to see whether any
changes suggested adverse events.
2.3. Procedures and treatmentsThis study was a pilot study conducted as 8-week, doubleblind,placebo-controlled, randomized trial. A random list ofnumbers was generated by computer. After being randomlyassigned to various treatment groups. Each participant receivedone capsule of placebo or Centella asiatica extract at variousdoses ranging 250, 500 and 750 mg once daily. Placebo andCentella asiatica capsules had the same colour, texture, size andsmell.All participants were assessed baseline data about cognitivefunction, mood and quality of life and then they were assessedcognitive performance and mood after the single administration,1 and 2 months of treatment whereas the quality of life wasassessed after 2 months of treatment.The code for study allocation was only broken when the lastparticipant completed the entire follow up. Staff involved in thecollection of the study’s endpoints was instructed to follow arigorous protocol and not to discuss any issues related to the useof medication. The review of compliance with medication andside effects was performed independently by the investigators,who were also blinded to group allocation. Subjects were askedto call the study center if they experienced any medical problemsduring the 60-day study period. At the end of the study, they werealso asked about adverse events. Laboratory tests were drawn atbaseline and follow-up visits and compared to see whether anychanges suggested adverse events.
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