- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617900
Efficacy of Ginger Extract (Compare Between the Ginger Preparation of Ancient Concept of Thai Traditional Practitioner, Standard Drug and Placebo) by Using Pain Score to Evaluate After Pain of Three Groups of First Normal Postpartum Women.
EFFICACY OF GINGER EXTRACT ON PAIN RELIEF FOR FIRST NORMAL POSTPARTUM WOMEN
Introduction A common problem in women after childbirth is bleeding (5-8 percent). This is one of the leading causes of maternal death in Thailand. The incidence of postpartum hemorrhage is approximately 1-2 percent of the births. A second problem is infection after birth which is a leading cause of illness and death of the mother. Incidence of infection after childbirth is 1-2 percent of women in developed countries and 5-10 percent of postpartum women overall. Staphylococcus aureus bacterium is found in the reproductive system of 5-9 percent of women. Perineal wound infections cause perineal pain. Thirdly is the problem of insufficient milk in foreign countries, mothers breastfeeding for less than 12 months total 94.7 percent. The fourth problem is difficult urination after vaginal delivery or 6 hours after removing the catheter in surgical cases. It is a common and important problem from 1.7 to 17.9 percent. The above problem causes infection and inflammation pain.
The first 24 hours after birth to 6 weeks physical and physiological changes of maternal organs and systems occurs such as the decline in hormone levels. This includes human placental lactogen (HPL), human chorionic somatomammotropin (HCS), human chorionic gonadotropin (HCG), estrogen, progesterone, prolactin, follicular stimulating hormones, luteinizing hormones. There is also blood loss. The clinical difficulties found in the postpartum period include after pain, perineal pain, breast engorgement, puerperal diuresis, weight loss, fever, pain and discomfort after birth. And the pain decreases or is lost in 3 days after birth.
The original gate-control theory proposed that there is a physiological within the substantia gelatinosa of the spinal cord's dorsal horn grey matter. It is suggested that sensory signals can only pass through the cells in the substantia gelatinosa when the gate is open. When the gate is closed, sensory information is blocked, and this forms the basis of a kind of physiological pain relief.
In relation to the 4 basic life elements of earth, water, wind and fire, the maternal body is lacking wind. This causes the fire to also decrease and the element of pain results. It becomes important to restore balance by stimulating blood circulation and herbal treatment is desirable to help the fire of the blood to speed the element of wind through the body.
Thai Traditional Medicine is used to treat the pain of mothers after childbirth. Because of in balance of mind fire in the body. By this reason, the balance of fire and wind increase to spread the circulatory system. Medicinal plants can increase the element of fire and the wind. Also, in Thai Traditional Medicine concept, pain reduction for postpartum mothers includes regular massage, herbal steam, herbal breast compress, Tub Mhor Kluer, eating heat-producing food. In the Thai Traditional Medicine manuscript, Kam-pee Mahachotharat there are 85 remedies for blood treatment therapy and especially, 44 contain ginger. Representing 51.76 percent of then.
Ginger has been included in the National Essential Medicines Catalogue 2554. Medication to relieve heartburn, bloating and distension, is documented and prevention and relief of nausea and vomiting due to motion sickness, seasickness. Or after surgery, are all included.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
1.2 Objectives
1.2.1 Primary Objective To compare the efficacy of ginger extract on pain relief at the following anatomical locations. Uterus, episiotomy and breast.
1.2.2 Secondary Objectives 1.2.2.1 To study the biological activity and stability of ginger extract. 1.2.2.2 To compare pain scores by using ginger extract for first normal postpartum women.
1.3 Benefit of Output 1.3.1 Knowledge on standard and the stability of ginger extract. 1.3.2 Knowledge on the effectiveness of ginger extract on pain relief for first normal postpartum women.
1.3.3 Knowledge on clinical research of pain relief for first normal postpartum women in the next big group volunteers.
1.3.4 Agencies involved in the field of conventional medicine and Thai Traditional Medicine may use results for study, further research and development of new drugs.
1.4 Operational Definition 1.4.1 Efficacy of ginger extract referred to changes result from receive ginger extract.
1.4.2 Pain referred to IASP (International Association for the Study of Pain) pain that persists beyond normal healing time p>24 hours.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Pathumthani, Thailand, 12121
- Naphatsaran Roekruangrit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female.
- Being 20-34 years of age.
- First normal, healthy showing no symptoms of disorder. No history of toxemia of pregnancy, liver disease, kidney disease and gastrointestinal bleeding during pregnancy or after participating in a research project.
- Healthy pregnant women.
- No postpartum hemorrhage.
- Agrees to consent form.
- No need to take medication regularly.
- No smoking, no drinking alcohol during pregnancy.
Exclusion Criteria:
- Unable to travel conveniently.
- Allergic to modern medicine or herbal remedies.
- Have a gallstone problem.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Lactose monohydrate 400 mg/capsules
500 mg paracetamol.
use in need
|
Active Comparator: Paracetamol
|
500 mg paracetamol.
use in need
|
Experimental: Ginger
|
500 mg paracetamol.
use in need
Ginger extract is contains 100 mg/capsules.
Use 2 capsules 3 times/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Scores on the numeric rating scale at 3 days
Time Frame: 2 hours after delivery time and be continued every 6 hours for 3 days.
|
measurement tool is numeric rating scale: NRS.
Score from 0 to 10. Inclusion criteria start at Pain was classified as Mild (1-3), Moderate (4-6), and Severe (7-10).
|
2 hours after delivery time and be continued every 6 hours for 3 days.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Preecha Wanichsetakul, M.D., Thammasat University
- Study Chair: Arunporn Itharat, PH.D., Thammasat University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Thammasat University (Other Identifier: Faculty of Medicine, Thammasat University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Disorder
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
-
Marinus PharmaceuticalsCompletedBehavioral Symptoms | Depressive Disorder | Depression | Mood Disorders | Pregnancy Complications | Depression, Postpartum | Mental Disorder | Postpartum Disorder | PPD | Postpartum BluesUnited States
-
The Jones InstituteUnknownPostpartum Depressive Mood | Postpartum Sexual FunctionUnited States
-
Universidad Complutense de MadridUniversidad Pontificia de SalamancaRecruitingPostpartum Depression | Postpartum DisorderSpain
-
Johns Hopkins UniversityUniversity of VirginiaRecruitingPostpartum Depression | Bipolar Disorder | Major Depressive Disorder | Postpartum PsychosisUnited States
-
University Hospital, Clermont-FerrandUnknownPostpartum Depression | Postpartum Hemorrhage | Postpartum Women | Postpartum Stress | Postpartum AnxietyFrance
-
University of PittsburghAmerican Psychological Foundation; The Pittsburgh FoundationRecruitingPostpartum Depression | Pregnancy Related | Psychological Distress | Postpartum Sadness | Postpartum Anxiety | Postpartum BluesUnited States
-
Rhode Island HospitalNational Institute of Mental Health (NIMH); The Depressive and Bipolar Disorder...CompletedDepression | Postpartum Depression | Major Depressive DisorderUnited States
Clinical Trials on Placebo oral capsule
-
Sao Thai Duong Joint Stock CompanyBig Leap Clinical Research Joint Stock CompanyCompleted
-
Brigham and Women's HospitalCompleted
-
Georgetown UniversityNational Institutes of Health (NIH)RecruitingDementia With Lewy BodiesUnited States
-
Aelis FarmaNational Institute on Drug Abuse (NIDA)CompletedHealthy VolunteersUnited States
-
Brigham and Women's HospitalEnrolling by invitation
-
EicOsis Human Health Inc.National Institute of Neurological Disorders and Stroke (NINDS)CompletedHealthy AdultsUnited States
-
Brigham and Women's HospitalCompleted
-
Yale UniversityNeurocrine BiosciencesRecruitingTrichotillomania (Hair-Pulling Disorder)United States
-
Alkermes, Inc.Terminated
-
InFlectis BioScienceAssistance Publique Hopitaux De Marseille; Qualissima; Eurofins Optimed; Stragen...Completed