1. Home
  2. Approved trials
  3. » فارسی

The effects of curcumin supplementation along with manual therapy on Metabolic Parameters, Inflammatory Markers, Oxidative Stress, and Electromyography in Frozen Shoulder Patients: A Randomized Clinical Trial

Protocol summary

Study aim
Evaluation the effect of curcumin-piperine supplementation and manual therapy on metabolic indicators, inflammatory markers, oxidative stress, and electromyography in patients with frozen shoulder
Design
A randomized controlled clinical trial with parallel groups, phase 3, on 60 patients suffering from frozen shoulder
Settings and conduct
Eligible people will be selected with the approval of a orthopedic specialist and will enter the study with full consent. The duration of supplemental is 12 weeks. Blood samples will be taken from all patients to determine and compare the effect of curcumin-piperine and manual therapy or manual therapy on biochemical indicators. All patients are asked to return unused supplements at each visit.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients diagnosed with frozen shoulder by an orthopedic specialist, aged between 20 and 65 years, who are willing to participate in the study. Exclusion Criteria: Individuals suffering from other skeletal diseases, those who have shown reactions or sensitivities to the prescribed supplement, individuals who fail to attend various stages of the study, and smokers
Intervention groups
The subjects of the intervention group, will recieve one curcumin piperine capsule daily (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy (4 sessions) for 14 days and the control group will recieve manual therapy (4 sessions) for 14 days.
Main outcome variables
Inflammatory indices, antioxidant status, metabolic factors, clinical signs, electromyography

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N64
Registration date: 2024-06-15, 1403/03/26
Registration timing: registered_while_recruiting

Last update: 2024-06-15, 1403/03/26
Update count: 0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of curcumin supplementation along with manual therapy on Metabolic Parameters, Inflammatory Markers, Oxidative Stress, and Electromyography in Frozen Shoulder Patients: A Randomized Clinical Trial
Public title
The effects of curcumin-piperine supplementation along with manual therapy on Frozen Shoulder Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Agreement for participation in the study Age of 20 to 65 years old Diagnosis of frozen shoulder syndrome patients by an orthopedic specialist (all grades)
Exclusion criteria:
Not attending follow-up appointments during various phases of the study Reaction and sensitivity to the prescribed supplement Non-compliance with recommendations and nutritional supplements Intensification of pain and more limitation in joint function Inflammatory diseases such as rheumatoid arthritis, osteoarthritis and lupus Patients with other skeletal, nervous, muscular diseases in the neck and upper limbs
Age
From 20 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through the official website https://www.sealedenvelope.com/simple-randomiser/v1/list. The participants will be randomly (classified by randomized block method) in one of the two curcumin-piperine supplement groups along with hand therapy and only hand therapy, as the control group. In order to distribute patients into intervention and control groups, first, people will be classified by age and divided using blocks of four. Randomization is done inside each block based on the random chain that will be extracted from the site.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.089

Health conditions studied

1

Description of health condition studied
Frozen Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
Evaluation of pain and disability in patients with frozen shoulder
Timepoint
At baseline and after 14 days
Method of measurement
Questionnaire

2

Description
serum level of C-reactive protein (CRP)
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

3

Description
Total antioxidant capacity
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.

4

Description
Total oxidant status
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.

5

Description
Muscle nerve band
Timepoint
At baseline and after 14 days
Method of measurement
Electromyography

6

Description
Malondialdehyde
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.

7

Description
Serum concentration of glutathione
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.

8

Description
Superoxide dismutase activity
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.

9

Description
Serum level of vascular cell adhesion molecule-1
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

10

Description
erythrocyte sedimentation rate (ESR)
Timepoint
At baseline and after 14 days
Method of measurement
biochemical kit of KiaZist Co.

11

Description
serum level of IL-6
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

12

Description
serum level of TNF-a
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

13

Description
serum level of TGF
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

14

Description
serum level of IL-1β
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

15

Description
serum level of IL-8
Timepoint
At baseline and after 14 days
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

Secondary outcomes

1

Description
The average level of total cholesterol (HDL, LDL, TG) in the intervention and control groups
Timepoint
before and after intervention
Method of measurement
Kiazist biochemical kit

2

Description
The mean level of fasting blood sugar (FBS) among the intervention and control groups
Timepoint
Before and after intervention.
Method of measurement
Kiazist biochemical kit

Intervention groups

1

Description
Intervention group: Intervention group: For 14 days, receiving capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine) along with manual therapy.
Category
Treatment - Drugs

2

Description
Control group: For 14 days, they will only receive manual therapy.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthopedic clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Shamsabadi
City
isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3222 2127
Email
askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Askari
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Esfahan University of Medical Sciences, Research and Technology Vice-Chancellor
Grant code / Reference number
1402405
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences, Research and Technology Vice-Chancellor
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3792 3060
Email
askari@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3792 3060
Email
askari@mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3792 3060
Email
askari@mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...