This study was designed to investigate the effect of Zingiber capsule (Zintoma) on reducing postpartum after pain. 124 women who will be admitted in Mahdieh hospital postpartum unit participate according to inclusion criteria including vaginal delivery at the gestational age more than 38 weeks or birth weight more than 2500 grams; at least one breast feeding session after delivery; absence of allergy to any herbal medicine; absence of addiction to narcotic drugs; absence of excessive hemorrhage, diabetes, hypertension and persistent fever. Ginger and placebo 250 mg capsules, prepared by Gol-Daru company, will be kept in a box next to each other for one week to get same smell. This job will be done by a trusted midwife without researcher’s knowledge. Then the midwife will put 4 capsules in each box and will label A or B. If they are satisfied to participate in the study, they have to complete demographic questionnaire. 2 hours after delivery, the severity of pain will be measured by Higam chart and if they acquire score 4 or more, the researcher will give them 2 A or B capsules with 2 Mefenamic acid capsules (as a routine treatment). Then pain intensity will be charted half an hour, one hour and two hours after taking medication. The second and third dose (one capsule) is administered every 8 hours. If they need extra sedative, they should record the time and the number of extra medications. Main outcomes: pain intensity and pain relief time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707283860N33
Registration date:2017-11-17, 1396/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-17, 1396/08/26
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of International Branch of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Study of the Effect of Ginger Plant Capsules on Reducing the Pain in Women with Postpartum Pain
Public title
Clinical trial Study of the Effect of Ginger Plant Capsules on Reducing the Pain in Women with Postpartum Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Iranian with reading and writing skills; Delivery by vaginal method; Pregnancy age of 38 weeks and more; The baby's weight more than 2500 grams; Having a living and normal baby; Mothers without previous cesarean or surgery history; lasting 2 hours after delivery; childbirth without the help of instrument (Vacuum and Forceps) or pressure on the uterus;absence of drug addiction; having no history of allergies to ginger and herbal medicine; mother with complains of after pain; absence of uses of medications and analgesia (epidural anesthesia, Spinal anesthesia, Entonox and pethidine)during labour; the mother is not affected by chronic disease, such as diabetes and hypertension; spontaneous existance of placenta and membrane.
Exclusion Criteria: Maternal complications such as increased postpartum hemorrhage, fever and blood pressure over 140/90; requiring surgery and anesthetics.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study was a three-blind study in which the researcher, samples and counselor are not known aboat the type of capsules. The capsules are placed in a coded container and randomly given to the participators.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Pharmacy and Midwifery Medical schools, Shahid Beheshti University of Medical Sci
Street address
Niyayesh Highway.,Valiasr st
City
Tehran
Postal code
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.782
Health conditions studied
1
Description of health condition studied
Postpartum pain
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
Pain intensity
Timepoint
Before the intervention, half,one and two hours after intervention, then every 8 hours
Method of measurement
Numerical Measurement Scale
Secondary outcomes
1
Description
The number of additional painkiller intake
Timepoint
2 hours after delivery and then every 8 hours for 24 hours
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Mefenamic acid at the dose of 500 mg (two 250mg capsules) plus Zintoma, Produced by Gol Dara Company, at the dose of 500 mg (two 250mg capsules) are prescribed two hours after delivery and then one Mefenamic acid and Zintoma are prescribed every 8 hours until 24 hours.
Category
Treatment - Drugs
2
Description
Control group: Mefenamic acid at the dose of 500 mg (two 250mg capsules) plus placebo (containing Chickpea Flour Produced by Gol Daru similar to Zintoma in Dose and shape) , at the dose of 500 mg (two 250mg capsules) are prescribed two hours after delivery and then one Mefenamic acid and one placebo are prescribed every 8 hours until 24 hours.