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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.

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ClinicalTrials.gov Identifier: NCT03617900
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Naphatsaran Roekruangrit, Thammasat University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postpartum Disorder Drug: Ginger Drug: Placebo oral capsule Drug: Paracetamol Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFICACY OF GINGER EXTRACT ON PAIN RELIEF FOR FIRST NORMAL POSTPARTUM WOMEN
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo oral capsule
Lactose monohydrate 400 mg/capsules

Drug: Paracetamol
500 mg paracetamol. use in need

Experimental: Ginger Drug: Ginger
Ginger extract is contains 100 mg/capsules. Use 2 capsules 3 times/day

Drug: Paracetamol
500 mg paracetamol. use in need

Active Comparator: Paracetamol Drug: Paracetamol
500 mg paracetamol. use in need




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female.
  2. Being 20-34 years of age.
  3. 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.
  4. Healthy pregnant women.
  5. No postpartum hemorrhage.
  6. Agrees to consent form.
  7. No need to take medication regularly.
  8. No smoking, no drinking alcohol during pregnancy.

Exclusion Criteria:

  1. Unable to travel conveniently.
  2. Allergic to modern medicine or herbal remedies.
  3. Have a gallstone problem.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617900


Locations
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Thailand
Naphatsaran Roekruangrit
Pathumthani, Thailand, 12121
Sponsors and Collaborators
Thammasat University
Investigators
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Study Chair: Preecha Wanichsetakul, M.D. Thammasat University
Study Chair: Arunporn Itharat, PH.D. Thammasat University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Naphatsaran Roekruangrit, Principle investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT03617900    
Other Study ID Numbers: Thammasat University
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Naphatsaran Roekruangrit, Thammasat University:
ginger extract
pain relief
postpartum women
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics