Determining the effects of curcumin in patients with chronic venous insufficiency on wound healing in a double-blind clinical trial
Design
This study is a double-blind randomized clinical trial. Using the provincial hospital registry system at random, patients with chronic venous insufficiency are invited to participate in the present study if they wish. The researchers explained to the patients the purpose of the research and if they wish to enter the study, the informed consent form will be completed by the patients
Settings and conduct
Using the provincial hospital registry system at random, patients with chronic venous insufficiency are invited to participate in the present study if they wish.
The patients admitted to the study will take 1 curcumin tablet per day at a dose of 500 mg and the control group will receive a placebo. After 6 weeks, the disease improvement criteria will be compared between the two groups. The raw material of placebo and curcumin is provided by Sami Labs LTD (Bangalore, India). Each 500 mg tablet of curcumin (which is a C3 complex), as well as each placebo tablet, contains 5 mg of piperine.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients with chronic venous ulcers (clinical class 6 chronic venous insufficiency) and exclusion criteria include patient dissatisfaction and patient referral for follow-up and liver failure and the presence of biliary obstructive problems.
Intervention groups
Curcumin tablets 500 mg once daily for 6 weeks
Main outcome variables
Wound surface, reduction of edema, heaviness, and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220404054408N1
Registration date:2022-08-18, 1401/05/27
Registration timing:registered_while_recruiting
Last update:2022-08-18, 1401/05/27
Update count:0
Registration date
2022-08-18, 1401/05/27
Registrant information
Name
shirin saberianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
saberianpoursh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of curcumin in people with chronic venous insufficiency on wound healing
Public title
Evaluation of the effects of curcumin in people with chronic venous insufficiency
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with inclusion in the study
Having an age range between 30 and 60 years
Having chronic venous insufficiency class 3 and above
Exclusion criteria:
Having other vascular diseases
Having diabetes
Having autoimmune diseases
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block
The block randomization method is used so that blocks with size 4 are a combination of letters A and B.
(ABBA, ABAB, AABB, BAAB, BBAA, BABA) The required number is selected using a table of random numbers and individuals are assigned to groups according to the created sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main tablets and placebo are exactly the same color and shape as the main tablets, so the participants can not understand the difference between the two.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical science
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.002
Health conditions studied
1
Description of health condition studied
Chronic venous insufficiency
ICD-10 code
A52.0
ICD-10 code description
Cardiovascular and cerebrovascular syphilis
Primary outcomes
1
Description
Wound healing
Timepoint
6 weeks
Method of measurement
Wound length and width
2
Description
Reduce edema
Timepoint
6 weeks later
Method of measurement
Clinical examinations by a subspecialty physician and comparison with pre-interference
3
Description
Feeling of heaviness and pain
Timepoint
6 weeks later
Method of measurement
Clinical examinations by a subspecialty physician and comparison with pre-interference
Intervention group:These patients are given tablets containing 500 mg of curcumin (C3 complex) from Sami Labs LTD (Bangalore, India) and 5 mg of piperine orally for 6 weeks.
Category
Treatment - Drugs
2
Description
Placebo tablets containing 5 mg of piperine, which are the same shape and color as the tablets of the intervention group, are given daily for 6 weeks and are provided by Sami Labs LTD (Bangalore, India).