1. Home
  2. Approved trials
  3. » فارسی

Comparison of the Effects of Group B Vitamins (B1, B6, B12) and Krocina on Pain and EMG-NCV Changes in Carpal Tunnel Syndrome Patients

Protocol summary

Study aim
Determining the therapeutic effect of group B vitamins and Krocin on carpal tunnel syndrome
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 150 patients. The rand function of Excel software was used for randomization
Settings and conduct
After obtaining written consent, 150 patients referred to social security hospital will be assigned to 6 study groups by block random method without blinding. The 1st, 2nd, 3rd, 4th and 5th groups are patients who, in addition to the standard treatment, take 300 mg of B1 daily, 120 mg of B6 daily, 1000 micrograms of B12 daily, the combination of all three vitamins, and 15 mg of krocin daily for one month. The sixth group receives only the standard treatment. Demographic and clinical information of patients, Boston pain questionnaire and neuromuscular tape are checked for patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18 years and older with carpal tunnel syndrome with residual latency greater than 3 in the muscle nerve strip, positive Falen's or Tinel's sign or positive pressure test Exclusion criteria: Dissatisfaction of patients, history of allergy to group B supplements or krocin, liver failure, diabetes, other neuropathic diseases, use of other medicinal supplements with antioxidant properties (vitamin E and C and group B) in the last three months
Intervention groups
The 1st, 2nd, 3rd, 4th and 5th groups are patients who, in addition to the standard treatment, take 300 mg of B1 daily, 120 mg of B6 daily, 1000 micrograms of B12 daily, the combination of all three vitamins, and 15 mg of krocin daily for one month. The sixth group receives only the standard treatment.
Main outcome variables
Pain intensity, functional status and severity of clinical symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200721048159N8
Registration date: 2024-12-05, 1403/09/15
Registration timing: prospective

Last update: 2024-12-05, 1403/09/15
Update count: 0
Registration date
2024-12-05, 1403/09/15
Registrant information
Name
Forouzan Ahmadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0239
Email address
ahmadpoor.f@lums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Group B Vitamins (B1, B6, B12) and Krocina on Pain and EMG-NCV Changes in Carpal Tunnel Syndrome Patients
Public title
Effects of Group B Vitamins and Krocina in Carpal Tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Occurrence of carpal tunnel syndrome diagnosed by a neurologist Patients aged 18 years and older Having a residual latency of more than 3 in the muscle nerve strip Falen's sign or positive Tinel's test or positive Pressure test
Exclusion criteria:
Dissatisfaction of patients History of allergy to group B supplements or krocina History of liver failure Using other medicinal supplements with antioxidant properties (vitamin E and C) in the last three months Using B6, B12 and B1 supplements before the study Suffering from diabetes or other neuropathic diseases as diagnosed by a neurologist
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization can be done by using the block identifier table and the samples are selected randomly
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Office of Research Ethics Committee, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road
City
Khorramabad
Province
Lorestan
Postal code
381351698
Approval date
2024-04-23, 1403/02/04
Ethics committee reference number
IR.LUMS.REC.1403.096

Health conditions studied

1

Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb

Primary outcomes

1

Description
VAS pain measurement due to carpal tunnel syndrome
Timepoint
Before starting the study and then one month later
Method of measurement
VSA test questionnaire

2

Description
Residual latency in the Electromyography-Nerve Conduction Velocity
Timepoint
Before starting the study and then one month later
Method of measurement
Electromyography-Nerve Conduction Velocity test

3

Description
Symptom severity and functional status
Timepoint
Before starting the study and then one month later
Method of measurement
Boston Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: patients who, in addition to receiving standard treatment, receive daily dose of vitamin B1 300 mg tablets (Kharazmi company) for one month.
Category
Treatment - Drugs

2

Description
The second intervention group: patients who, in addition to receiving standard treatment, receive daily dose of vitamin B6 120 mg tablets (Kharazmi company) for one month.
Category
Treatment - Drugs

3

Description
The third intervention group: patients who, in addition to receiving standard treatment, receive daily dose of vitamin B12 1000 mcg tablets (Kharazmi company) for one month.
Category
Treatment - Drugs

4

Description
The fourth intervention group: patients who, in addition to receiving standard treatment, receive daily dose of vitamin B12 1000 mcg, B 6 120 mg, and 300 mg B1 tablets (Kharazmi company) for one month
Category
Treatment - Drugs

5

Description
The fifth intervention group: patients who, in addition to receiving standard treatment, receive daily dose of krocina 15 mg tablets (Sami Saz Co) for one month
Category
Treatment - Drugs

6

Description
Control group: Receive standard treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorramabad Social Security Hospital
Full name of responsible person
Forouzan Ahmadpour
Street address
Kilometer 2 of Khuzestan Road, East Goldasht, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6819789691
Phone
+98 66 3341 3100
Email
khoramabad.hos@tamin.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpoor
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor of Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
ahmadpourforoz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor of Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
ahmadpourforoz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Assistant Professor of Clinical Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
ahmadpourforoz@yahoo.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...