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.

NCT03617900 | Completed Phase 1 DMC

• 1 other identifier: Thammasat University
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Disorder

Keywords

ginger extract; pain relief; postpartum women

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scores on the numeric rating scale at 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.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule; Drug: Paracetamol

Ginger

EXPERIMENTAL

Drug: Ginger; Drug: Paracetamol

Paracetamol

ACTIVE COMPARATOR

Drug: Paracetamol

Interventions

Ginger DRUG

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

Ginger

Placebo oral capsule DRUG

Lactose monohydrate 400 mg/capsules

Placebo

Paracetamol DRUG

500 mg paracetamol. use in need

Ginger; Paracetamol; Placebo

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unable to travel conveniently.
• Allergic to modern medicine or herbal remedies.
• Have a gallstone problem.

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Naphatsaran Roekruangrit

Pathum Thani, 12121, Thailand

Location

Related Publications (1)

• 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.

  PMID: 33078388 DERIVED

MeSH Terms

Conditions

Puerperal Disorders

Interventions

ginger extract; Acetaminophen

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Preecha Wanichsetakul, M.D.

  Thammasat University

  STUDY CHAIR

• Arunporn Itharat, PH.D.

  Thammasat University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: August 7, 2018
• Study Start: August 29, 2018
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

TH (1)