investigating the efficacy of Cyperus rotundus herbal oral product on the treatment of mild to moderate Alzheimer disease.
Design
A clinical trial with a control group, with a parallel group, double-blind, randomized, phase 2-1 on 30 patients, for randomization, the rad function of Excel software was used.
Settings and conduct
Patients with mild to moderate Alzheimer's who are referred to a neurologist's office or the Alzheimer's Clinic of Iran are randomly assigned to the study groups (random allocation rule). The researcher and the patient do not know about the allocation of the drug or placebo until the end of the study, and the study is a two-way blind.
Participants/Inclusion and exclusion criteria
Inclusion:
age over 55 years
MMSE score between 16 and 22,
Or level 4 or 5 on the FAST test
Exclusion:
Severe depression,
Having uncontrolled metabolic diseases
Substance abuse and alcohol dependence
Intervention groups
The intervention group received capsules containing 250 mg of dried cyperus rotundus root powder prepared by Sanabel Pharma co.Ltd twice a day for 8 weeks and the placebo group received capsules containing breadcrumbs with the same taste, shape and aroma produced by Sanabel Pharma co.Ltd twice a day for 8 weeks.
Main outcome variables
Brain Mizaj
Mental status
Cognitive function
Alzheimer's severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220625055269N1
Registration date:2023-02-26, 1401/12/07
Registration timing:prospective
Last update:2023-02-26, 1401/12/07
Update count:0
Registration date
2023-02-26, 1401/12/07
Registrant information
Name
Leila Moein Lashkajani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2288 2596
Email address
leilamoein@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cyperus rotundus herbal oral product on the treatment of mild to moderate Alzheimer disease.
Public title
the effect of Cyperus rotundus herbal oral product on the treatment of mild to moderate Alzheimer disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female over the age of fifty-five
with mild to moderate Alzheimer's disease diagnosed by a neurologist according to the NINCDS-ADRDA criteria.
Exclusion criteria:
major depression
Having a congenital cognitive disorder
Structural disorders of the brain
poor control diabetes
Age
From 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
computer generated list of random numbers (random number generator)
random is generated by the statistician by a computer software. The pharmacist numbers the drug containers based on the allocation sequence. The PI enrolls the participants and assigns them to interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebos are prepared by a person other than the researcher and colleagues involved in the research in identical containers with the same label, shape and aroma, and the researcher and the patient have no knowledge of the presence of a placebo or real medicine in the medicine package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethic committee of Shahed university
Street address
Zarafshan ave, Simaye Iran Ave
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.SHAHED.REC.1401.118
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Cognitive function
Timepoint
week 0, week 4 and week 8
Method of measurement
MMSE & FAST questionnaire
2
Description
Brain Mezaj
Timepoint
week 0 and 8
Method of measurement
Fattahi bran Mezaj questioner
Secondary outcomes
1
Description
Alzheimer severity
Timepoint
week 0 and 8
Method of measurement
clinical dementia rating scale-CDR
Intervention groups
1
Description
The intervention group received capsules containing 250 mg of dried Saad Kofi root powder prepared by Sanabel Pharma Co.Ltd twice a day for 8 weeks. MMSE, FAST, CDR cognitive tests are taken from patients before the study and at the end of the eighth week by standard questionnaires. Before the start of the study and at the end of the fourth and eighth weeks, the patients are visited by a neurologist for free, and whenever necessary, the patients can contact the doctor in charge of the study by phone and ask him from Inform the possible side effects of the drug.
Category
Treatment - Drugs
2
Description
Control group: The control group also received oral capsules containing breadcrumbs made by Sanabel Pharma Co.Ltd twice a day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of Neurologists and Iran Alzheimer's Association Clinic
Full name of responsible person
Leila Moein Lashkajani
Street address
3rd Dashtestan, Pasdaran ave
City
Tehran
Province
Tehran
Postal code
1947817881
Phone
+98 21 2288 2521
Fax
+98 21 2288 2521
Email
leilamoein@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Leila Moein Lashkajani
Street address
The beginning of the Tehran-Qom freeway, in front of the shrine of Imam Khomeini
City
Tehan
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
leilamoein@gmail.com
Web page address
https://shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Leila Moein Lashkajani
Position
physician, PHD student of Persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
3rd Dashtestan, pasdaran ave. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1947817881
Phone
+98 912 299 7633
Email
leilamoein@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Leila Moein Lashkajani
Position
Physician PHD student of Persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
3rd Dshtestan, Pasdaran ave. Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1947817881
Phone
+98 21 2288 2521
Fax
+98 21 2288 2596
Email
leilamoein@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Leila Moein Lashkajani
Position
MD.PHD student of Persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
3rd Dshtestan, Pasdaran ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1947817881
Phone
+98 21 2288 2596
Fax
+98 21 2288 2521
Email
leilamoein@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In order to comply with the principle of confidentiality and non-disclosure of patients' private and confidential information