As a pure preparation of traditional Chinese medicine,it has the same curative theory to chemical medicine glucobay while no side effects existed,such as hypoglycemia etc.It has preventive and curative effect on blood vessel symptom complicated by diabetes.
Please read the instruction carefully and use it under physician?ˉs suggestion.
[Medicine Name]
Proprietary name: Jintangning Capsule
Chinese pronunciation: Jintangning Jiaonang
[Ingredients] Faeces Bombycis, Radix Glycyrrhizae
[Description] Capsule containing brownish-yellow grains or powder. It tastes a litter bitter.
[Functions & Indications]Eliminating dampness, invigoratingblood circulation and relieving pain. Used for the type 2-diabetic patients. Theclinic symptoms can be seen as abdominal fullness and distention, lacking instrength, discomforting evacuation, numbness of the limbs and limbs pain.
[Specification] 0.55 gram each capsule
[Usage & Dosage] Immediately take orally 3 timesper day with 4 pieces each time before dinner. The course is 4 weeks.
[Adverse Reactions] Found individual patient appear like swirl, headache, diarrhea, windy, nausea, vomit, painful right- kidney , lumbago, manifold fart ,tetter, tickle.
[Contraindications] Not known
[Precautions] Inspection blood sugar, heart function, renal function and liver function periodically during use this medicine.
[Clinical Test] It was approved by State Drug Administration (SDA) to carry on a randomized, double blind, double dummy, parallel control, mutlticenter clinical study during Aug. 2002 to Sep. 2004 with this drug. Phase ￠ò Trials: In 103 cases of trail group, 6 cases dropped out and 14 cases excluded. In 109 cases of control group, 8 cases dropped out and 9 cases excluded. Phase￠ó Trials: In 338 cases of trail group, 21 cases dropped out and 22 cases excluded. In 112 cases of control group, 7 cases dropped out and 8 cases excluded.
Diagnostic criteria:
The diagnostic criteria of Diabetes in modern medicine (according to 1999 WHO specialist consultant report):
Fasting plasma glucose (FPG) ?Y 7.0mmol/L (126mg/dl)
Or in oral glucose tolerance test(OGTT), 2h plasma glucose (2HPG) ?Y 11.1 mmol/L(200mg/dl)￡?
Or random blood sugar ?Y 11.1 mmol/L(200mg/dl).
TCM differentiation:
Retention of dampness in middle-JIAO and blood stasis.
The 2 weeks introduction period before the experiment is for those with poor blood sugar control after above 4 weeks Sulphanylureas or Biguanides treatment, or fasting plasma glucose/2h after glucose load still consistent with the diagnosis.
Observation item: blood glucose (fasting, 2h plasma glucose), Glycated Hemoglobin (HbAlc) and TCM syndromes.
Curative effect standard:
1.Curative effect standard of modern medicine:
Compare on the different of FPG, 2hPG and HbAlc between pretherapy and post-therapy. Compare on down-range between different groups.
2.Curative effect standard of TCM syndrome:
Excellence￡odecrease of TCM Syndrome Score ?Y 70￡￥
Utility￡odecrease of TCM Syndrome Score ?Y 30￡￥
Inefficacy￡odecrease of TCM Syndrome Score <30￡￥.
Administrations: Take the placebos for 2 weeks during the introduction period. Jintangning capsules were taken by oral instantly before diner, four pills one time and thrice one day. Glucobay pills were taken by oral instantly before diner, one pill one time and thrice one day. And both take the placebos at the same time. The total treatment course extended for 4 weeks.
Trail results:
1.Curative effect of modern medicine (intention-to-treat):
Phase ￠ò Trials: The rate of FPG returning to normal in trail group is 35.0% and 25.0% in control group. The rate of 2hPG returning to normal in trail group is 61.5% and 54.7% in control group. The rate of HbAlc returning to normal (per protocol set) in trail group is 20.9% and 23.9% in control group.
Phase ￠ó Trials: The rate of FPG returning to normal in trail group is 38.0% and 32.6% in control group. The rate of 2hPG returning to normal in trail group is 54.9% and 54.8% in control group. The rate of HbAlc returning to normal (per protocol set) in trail group is 14.9% and 18.6% in control group.
2.Curative effect of TCM syndrome (intention-to-treat):
Phase ￠ò Trials: In trail group excellent rate is 62.50%, utility rate is 25.0%, total effective rate is 87.50%. In control group excellent rate is 65.35%, utility rate is 28.71%, total effective rate is 94.06%.
Phase ￠ó Trials: In trail group excellent rate is 43.53%, utility rate is 41.64%, total effective rate is 85.17%. In control group excellent rate is 42.86%, utility rate is 40.00%, total effective rate is 82.86%.
Adverse event rates:
Phase ￠ò Trials: It is 6.96% (8/115 cases) in trail group and 9.32% (11/118 cases) in control group. In trail group it displays as dizziness, headache, distention of head, distention of abdominal, diarrhea, loose stool, disgusting, vomit, hypoglycemia reactions, increasing flatus.
Phase ￠ó Trials: It is 3.34% (12/359 cases) in trail group and 4.20% (5/119 cases) in control group. In trail group it shows as pain in praecordium, dizziness, headache, distention of head, distention of abdominal, sour regurgitation, diarrhea, disgusting, vomit, pain in the right kidney area, lumbago, rash, hypoglycemia reactions, increasing flatus.
During the trail, in Phase ￠ò there were 55 cases (56.7%) of trail group which were supplied with the experimental medicine when taking Hypoglycemic agents(Dimethylbiguanide and Sulphanylureas, such as Metformin, Mindiab, Diamicron, Glimepiride, Glipizide XL, Glibenclamide and Xiaoke Wan)￡? and 64 cases (63.36%) in control group.
In Phase ￠ó there were 181 cases (57.09%) of trail group which were supplied with the experimental medicine when taking Hypoglycemic agents(Dimethylbiguanide and Sulphanylureas, such as Metformin, Mindiab, Diamicron, Glucophage, Glimepiride, Glipizide XL, Repaglinide, NovoNorm, Glibenclamide and Xiaoke Wan)￡? and 57 cases (54.28%) in control group.
[Storage] Preserve in tightly closed containers, stored in a cool and dry place
[Package] aluminum plate. 12pieces/sheet× 3sheets.plastic drug package, 36 pieces/bottle.
[Period of validity] Two years
[Administer standard] National medicine standard YBZ00142008
[Approval number] State medical permitment number. Z20080011
[Manufactured] By Zhangzhou Pien Tze Huang Pharmaceutical co .,Ltd.
