Postpartum DisorderPhase 1/2NCT03617900
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 study testing Ginger and Paracetamol in people with Postpartum Disorder, run by Thammasat University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Disorder
- What is being tested?
- Ginger and Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteThailand
- Study dates
- 29 Aug 2018to 25 May 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Unable to travel conveniently.
- Allergic to modern medicine or herbal remedies.
- Have a gallstone problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Postpartum Disorder
- Being tested
- Ginger, Placebo oral capsule, Paracetamol
- Keywords
- ginger extract, pain relief, postpartum women
- Medical subject headings
- Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
Ginger extract is contains 100 mg/capsules. Use 2 capsules 3 times/day
Placebo oral capsuleDrug
Lactose monohydrate 400 mg/capsules
ParacetamolDrug
500 mg paracetamol. use in need
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule; Drug: Paracetamol |
| Ginger | Experimental | Not described Receives: Drug: Ginger; Drug: Paracetamol |
| Paracetamol | Active comparator | Not described Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours after delivery time and be continued every 6 hours for 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start29 Aug 2018
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naphatsaran Roekruangrit, Thammasat University
- Investigators
- Preecha Wanichsetakul, M.D., Study chair, Thammasat UniversityArunporn Itharat, PH.D., Study chair, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617900
- Sponsor's protocol ID
- Thammasat University
- Status last verified
- May 2019
- First submitted
- 11 Jun 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF GINGER EXTRACT ON PAIN RELIEF FOR FIRST NORMAL POSTPARTUM WOMEN
- ClinicalTrials.gov ID
- NCT03617900
- Acronym / sponsor ID
- Thammasat University
- Conditions
- Postpartum Disorder
- Keywords
- ginger extract, pain relief, postpartum women
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsule, Drug: Paracetamol |
| Ginger | Experimental | Drug: Ginger, Drug: Paracetamol |
| Paracetamol | Active comparator | Drug: Paracetamol |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- Unable to travel conveniently.
- Allergic to modern medicine or herbal remedies.
- Have a gallstone problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerGinger extract is contains 100 mg/capsules. Use 2 capsules 3 times/day | Drug | Ginger |
| Placebo oral capsuleLactose monohydrate 400 mg/capsules | Drug | Placebo |
| Paracetamol500 mg paracetamol. use in need | Drug | Ginger, Paracetamol, Placebo |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Derived from this study: PubMed 33078388Deussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preecha Wanichsetakul, M.D. study chair
Thammasat University
Arunporn Itharat, PH.D. study chair
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ginger and Paracetamol in people with Postpartum Disorder, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.