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
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.
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.
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 →Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Drug: Placebo oral capsule · Drug: Paracetamol
Drug: Ginger · Drug: Paracetamol
Drug: Paracetamol
Ginger extract is contains 100 mg/capsules. Use 2 capsules 3 times/day
Lactose monohydrate 400 mg/capsules
500 mg paracetamol. use in need
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.
Ran from Aug 2018 to primary completion in May 2019, 8 months.
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Studies of the drug tested here: Ginger extract
Thammasat University