provide a memory enhancement supplement using traditional medicine
Design
To be included in the study, first the diagnosis of Alzheimer's disease is made based on a questionnaire and initial paraclinical examinations include brain imaging and metabolic evaluation and determination of serum TSH and vitamin B12 levels.
Settings and conduct
The intervention group consumes 4 capsules of herbal medicines containing piper and black cumin (2 in the morning and 2 at night) beside a conventional anti alzheimer disease drug for 6 months.
Participants/Inclusion and exclusion criteria
no pregnancy or breast feeding
no cardiovascular disease
no presents of depression
no sensitivity to herbal medicines presents in formulation
Intervention groups
The intervention group consumes 4 capsules of herbal medicines containing piper and black cumin (2 in the morning and 2 at night) beside a conventional anti alzheimer disease drug for 6 months.
Main outcome variables
serum B12؛ serum TSH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191212045709N3
Registration date:2020-11-14, 1399/08/24
Registration timing:registered_while_recruiting
Last update:2020-11-14, 1399/08/24
Update count:0
Registration date
2020-11-14, 1399/08/24
Registrant information
Name
Ramin Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4255
Email address
ansariramin94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the impact of a memory enhancer traditional oral formulation in management of dementia, a randomized controlled clinical trial.
Public title
Assessment of the impact of a memory enhancer traditional oral formulation in management of dementia, a randomized controlled clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of dementia based on DSM criteria
Exclusion criteria:
patients with cardiovascular disease
pregnancy
breast feeding
sensitivity to herbal medicines present in formulation
patients with depression
patients with peptic ulcer disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 66 patients were randomly divided in to two groups of
33 each in a randomized double-blind placebo-controlled design using permuted block randomization method. Samples are randomized by random blocking method with 4 blocks and by using the table of random numbers of the Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. Minimum sample size for each group was 13 patients. All patients received 2 capsules of the same-looking drug or placebo twice daily for 6 months.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be a double blind trial and only the evaluator knows the results and the code of the drug or placebo group.The capsules of the drug group and the placebo are quite similar in appearance.The drug and placebo groups will be separated by receiving a code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
shiraz- zand street
City
shiraz
Province
Fars
Postal code
7139745197
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.SUMS.REC.1398.963
Health conditions studied
1
Description of health condition studied
alzheimer disease
ICD-10 code
G32
ICD-10 code description
Other degenerative disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
TSH serum level
Timepoint
every 6 months
Method of measurement
serum sample
2
Description
B12 serum level
Timepoint
every 6 months
Method of measurement
serum sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: take 4 capsules daily, including pepper (one part), black cumin (one part) and sugar (3 parts) along with underlying drugs to control Alzheimer's for 6 months. The total consumption of the product per day is equal to 4.2 grams.
Category
Treatment - Drugs
2
Description
Control group: take 4 capsules containing starch daily as a placebo along with underlying drugs to control Alzheimer's for 6 months. Brain imaging and measurement of B12 and TSH levels are performed at the beginning and end of the study.