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.
Condition: Postpartum Disorder
MeSH terms: Puerperal Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Ginger; Placebo oral capsule; Paracetamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ginger extract is contains 100 mg/capsules. Use 2 capsules 3 times/day; Lactose monohydrate 400 mg/capsules; 500 mg paracetamol. use in need
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ginger extract; pain relief; postpartum women