Composition for Treating Uterine Fibroid (PP6)
Condition: Uterine Fibroids Affecting Pregnancy
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      Pregnenolone & Pyridoxal Phosphate (PP6) for treating uterine fibroids in women pregnancy to
      lost the size fibroids and to dissolve fibroids.

      Uterine fibroids are a very common finding in women pregnancy of reproductive age, fibroids
      fast grow in the first trimester pregnancy. PP6 against the rapid growth of fibroids under
      the influence of hormones during pregnancy. Use to PP6 think about regulating stable
      Oestrogen level and to dissolve fibroids.

      This is a substantial insight into the pathogenesis of disease, with a clear path toward
      clinical application, or which would lead to a substantial advance and perfect in management
      or public health policy.
    

Detailed description: 
      Uterine fibroids are a very common finding in women's pregnancy of reproductive age fibroids
      fast grow in the first-trimester pregnancy.

      Clinically has shown that:

        -  Uterine fibroids are associated with heavy or prolonged menstrual periods, abnormal
           bleeding between menstrual periods.

        -  Fibroids are associated with increased rates of spontaneous miscarriage, premature
           birth, placenta ablation, malpresentation, labor dysfunction, cesarean section, and
           postpartum hemorrhage, pain is the most common complication of fibroids uterus during
           pregnancy.

        -  Use the composition that has a sufficient Pregnenolone and combined with Coenzyme
           Pyridoxal Phosphate, this preparation will soften uterine fibroids and disappear
           fibroids.

      Pregnenolone is produced in the adrenal glands and the central nervous system. Pregnenolone
      is synthesized from Cholesterol and it is the precursor of Progesterone, Estrogen, and
      dehydroepiandrosterone (DHEA). In some people Pregnenolone will decrease with age, which will
      lead to an imbalance between Progesterone, Estrogen, according to research, this imbalance is
      the cause of abnormal growth of the uterine muscle fibers cells that produce multiple
      fibroids in the womb. Supplementation Pregnenolone is necessary for women of childbearing and
      reproductive age, overtime tracking pregnant women but there were fibroids from before
      pregnancy these fibroids will develop very quickly to stun the fetus many problems in
      pregnancy, and childbirth, the risk of miscarriage, preterm delivery,...The new drug will
      maintain a sufficient amount of Pregnenolone natural is the essence from Dioscorea persimilis
      prain & burkill and associated with a necessary element is Coenzyme Pyridoxal Phosphate.
      Compound presence in the body will curb the development exceed of the muscle fibers uterus,
      the muscle fibers in the fibroids will soften, spread out, and disappear fibroids. The uterus
      returns to its normal state, the fetus will develop naturally.

      Research results

        -  After 40 weeks of ultrasound examination:

             -  100% of women using PP6 drug have the disappearance of fibroids, only the image of
                uterine muscle is thicker than usual.

             -  100% of women who received PP6 placebo did not experience any beneficial progress.

        -  Through study completion, an average of 40 weeks
    

Intervention name(s): PP6; PP6 Placebo
Intervention type(s): Drug; Device
Intervention description(s): Dosage:
-Take 1tablet/2 times/day/in throughout pregnancy.; Dosage:
-Take 1tablet/2 times/day/in throughout pregnancy.
Other intervention name(s): Pregnenolone 40mg & Pyridoxal Phosphate 6mg; Pregnenolone & Pyridoxal Phosphate Placebo
Intervention MeSH terms: Pyridoxal; Pyridoxine; Vitamin B 6; Pyridoxal Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Selection of women ages 18 to 40, with pregnancy uterine fibroids and pregnancy in the 8th week of pregnancy.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment