The study aims at determining the effect of Curcuma Longa on cesarean wound healing. In this study mothers with the age range of 37-42 and with two deliveries were selected for the study and those with acute or chronic diseases and allergic records were excluded from the samples. The study will be conducted on 60 women referring to Imam Ali hospital for caesarian surgery in Amol who were randomly assigned to three groups of experimental, placebo and control. In the experimental group, a coded package of Curcuma Longa is given to the mothers and they will be trained on how to use them that is after thoroughly washing their hands and the wounds, they are expected to rub the cream on the area and repeat the steps twice a day for 16 days (12 hours ± 2) and complete the daily check list for the hygienic factors and the healing process on days 8 and 16 will be checked by a Cesarean experts (gynecologist). In placebo group, instead of using Curcuma Longa the Placebo type will be used and the control group will not receive anything.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206069958N1
Registration date:2013-05-10, 1392/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Ghahraman Mahmoudi
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 15 1317 5500
Email address
mahmudi.alemi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University-Sari Branch
Expected recruitment start date
2011-11-10, 1390/08/19
Expected recruitment end date
2012-09-09, 1391/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of curcuma longa cream and placebo on cesarean wound healing
Public title
Evaluation of the effects of curcuma longa cream and placebo on cesarean wound healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mothers in 37-42 ages of pregnancy; cesarean with beneath cut; approximate two previous cesareans
Exclusion criteria: serious' chronic sickness; cesarean with miomecotomy and Histrecotomy; using the effective drug on wound healing; allergic background.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Sari Branch
Street address
7th km of Sea Road, Sari, Iran
City
Sari
Postal code
4816119318
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
90-4
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
O90.0
ICD-10 code description
Disruption of caesarean section wound
Primary outcomes
1
Description
Wound Healing
Timepoint
Days of 8,16 after cesarean
Method of measurement
Reeda questionnaire
Secondary outcomes
1
Description
Cesarean Pain
Timepoint
Days of 8,16 after cesarean
Method of measurement
Pain visiable scale questionnare
Intervention groups
1
Description
In intervention group a package coded curcuma longa is delivered to the mother and trained how to use the cream. Means after complete washing of the hands and the wounds, cream the size of a finger placed on the suture zone and continue to do this twice a day (12 hours ±2) for up to 16 days and daily complete the check list to the consideration given training, then at the afternoon of 8th and 16th day of post cesarean in order to evaluate healing cesarean refer to gynecologist clinic. Cesarean Healing in supine position with a metal ruler was assessed using a scale REEDA 5 (Redness, swelling and bruising between the two edges of the wound secretion) and Pain is measured using the Visual Pain Scale. Mark of zero represents no pain and 10 indicating the worst pain.
Category
Treatment - Drugs
2
Description
In placebo group, placebo turmeric cream will use instead of turmeric cream.
Category
Placebo
3
Description
Intervention for the control group is not considered.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Nikpour Maryam
Street address
Imam Ali Hospital, Amol
City
Amol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Dr Mahmudi Ghahraman
Street address
7th km of Sea Road, Sari, Iran
City
Sari
Grant name
بودجه پژوهشي دانشگاه ازاد اسلامی، واحد ساری
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Sari Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahmudi Ghahraman
Position
PhD
Other areas of specialty/work
Street address
7th km of Sea Road, Sari, Iran
City
Sari
Postal code
4816119318
Phone
+98 15 1317 5500
Fax
+98 15 1213 2895
Email
ghahraman48@yahoo.commahmudi.alemi@iausari.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Nikpour Maryam
Position
MSc in Midwifery
Other areas of specialty/work
Street address
7th km of Sea Road, Sari, Iran
City
Sari
Postal code
4816119318
Phone
+98 15 1317 5500
Fax
+98 15 1213 2895
Email
marinikpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Sari Branch
Full name of responsible person
Mahmudi Ghahraman
Position
PhD
Other areas of specialty/work
Street address
7th km of Sea Road, Sari, Iran
City
Sari
Postal code
4816119318
Phone
+98 15 1317 5500
Fax
+98 15 1213 2895
Email
ghahraman48@yahoo.com mahmudi.alemi@iausari.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)