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.

NCT ID: NCT03617900

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-05-25

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.

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.

Conditions

Postpartum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Lactose monohydrate 400 mg/capsules

Paracetamol

Intervention Type: DRUG

500 mg paracetamol. use in need

Ginger

Group Type: EXPERIMENTAL

Ginger

Intervention Type: DRUG

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

Paracetamol

Intervention Type: DRUG

500 mg paracetamol. use in need

Paracetamol

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

500 mg paracetamol. use in need

Interventions

Ginger

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

Intervention Type: DRUG

Placebo oral capsule

Lactose monohydrate 400 mg/capsules

Intervention Type: DRUG

Paracetamol

500 mg paracetamol. use in need

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Naphatsaran Roekruangrit

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Preecha Wanichsetakul, M.D.

Role: STUDY_CHAIR

Thammasat University

Arunporn Itharat, PH.D.

Role: STUDY_CHAIR

Thammasat University

Locations

Naphatsaran Roekruangrit

Pathum Thani, , Thailand

Countries

Thailand

References

Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.

Reference Type: DERIVED

PMID: 33078388 (View on PubMed)

Other Identifiers

Thammasat University

Identifier Type: -

Identifier Source: org_study_id