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CompletedNCT03617900Updated May 29, 2019

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.

A Phase 1/2 interventional study of Ginger and Placebo oral capsule in Postpartum Disorder, sponsored by Thammasat University. Completed at 1 site in Thailand. Open to female participants aged 20 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by Thammasat University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
20 Years to 34 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postpartum Disorder

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Keywords

  • ginger extract
  • pain relief
  • postpartum women
03

In context

Puerperal Disorders

40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.

This study's enrollment of 99 is above the median of 81 across 32 interventional studies indexed under Puerperal Disorders.

Browse Puerperal Disorders studies →

Lead sponsor

Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 34 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Unable to travel conveniently.
  2. Allergic to modern medicine or herbal remedies.
  3. Have a gallstone problem.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
99 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo oral capsule · Drug: Paracetamol

  • Experimental
    Ginger

    Drug: Ginger · Drug: Paracetamol

  • Active comparator
    Paracetamol

    Drug: Paracetamol

Interventions

  • DrugGinger

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

  • DrugPlacebo oral capsule

    Lactose monohydrate 400 mg/capsules

  • 500 mg paracetamol. use in need

06

What researchers measure

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).

    Time frame: 2 hours after delivery time and be continued every 6 hours for 3 days.

07

Study locations

1 site
  • Naphatsaran Roekruangrit
    Pathumthani, 12121, Thailand
08

References and documents

Publications

  • 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. PubMed 33078388 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in May 2019, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2018
First posted
Aug 7, 2018
StartActual
Aug 29, 2018
Primary completionActual
May 25, 2019
CompletionActual
May 25, 2019
Last update
May 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03617900
Lead sponsor
Thammasat University
Responsible party
Naphatsaran Roekruangrit (Principle investigator, Thammasat University) — Principal investigator
First posted
Aug 7, 2018
Start date
Aug 29, 2018
Primary completion
May 25, 2019
Completion
May 25, 2019
Last update
May 29, 2019

Study contacts

Preecha Wanichsetakul, M.D.
study chair · Thammasat University
Arunporn Itharat, PH.D.
study chair · Thammasat University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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