Probiotics

Features of Changlekang (Oral　Clostridium　Butyricum　and　Bifidobacterium　Capsule, Live)

☆ First class national new drug

☆ New drug protection of 12 years and patent protection of 20 years

☆ Contains no disputed ingredients of live bacteria

☆ Two liver bacteria coordinate, quick and high effects, green and safe.

☆ Pregnant women and babies can use it safely

Indications

Acute and chronic diarrhea, enteritis, maladjustment of intestinal bacteria-group and dyspepsia arising from antibiotic, chronic hepatitis, etc.

Observation of clinical effects

pH of stool of subjects in middle and high dosage groups falls obviously, which may be related to the settlement and proliferation of clostridium and butyricum in intestinal tract and its increase with dosage rise. Bifidobacterium has a tendency to increase and increase obviously at high dosage level (p<0.05). Enteric bacilli has tendency of decline at middle and high dosage level.

Comparison of diarrhea times before and after treatment

Clinical trial shows that Changlekang is safe and effective in treatment of diarrhea

During the treatment of 90 cases of children suffering from diarrhea with Changlekang powder, the total effectiveness is 96.7% (total effectiveness of regular treatment group is 82.9%), obvious effectiveness of Changlekang group is 70.0% which is clearly better than regular treatment group (54.3%)(P<0.01)，the treatment effects are obvious and without side effects.

Changlekang has obvious effects in treating IBS

The trial shows that Changlekang capsule, powder and Miya tablet are equal in treatment of IBS. No adverse reactions are found, so the use of Changlekang for treatment of IBS is effective and safe.

The effects of Changlekang on Neonatal Jaundice

The effects of Changlekang on Neonatal Jaundice The effect is positive. No obvious adverse effect is observed. In addition, the patients eat more. The drug is worthwhile for clinical usage, esp. in grassroot hospitals.

Administration and dosage:

Capsule/powder

1. Orally taken by adults: 3 capsules/bag for each time, twice every day, taken with cold water. 3-7 days of administration for acute diarrhea; 14-21 days of administration for chronic diarrhea or according to doctor's advice.

2. orally taken by children: 1 capsule/bag each time, twice a day or according to doctor's advice, for those who can not swallow capsules, the powder in the capsule can be taken out and administered with cold boiled water, fruit juice or milk.

Pharmacology and toxicology:

The drug effect test in animal body showed that the product can stop the diarrhea of mice caused by ampicillin.

The test in vitro showed that clostridium butyricum can inhibit the growth of several kinds of intestinal pathogenic bacteria such as vibrio cholera biotype Eltor, 01, vibrio cholera 0139, enterohemorrhagic E. coli 0157 and etc. It can also inhibit the growth of shigella dysenteria and hog cholera salmonella.

In phaseⅠ-Ⅲ clinical trial，few patients have slight skin rash and stomach discomfort, the incidence rate of stomach discomfort is 0.88% and incidence rate of slight skin rash is 1.98%. It proves that Changlekang is really a safe drug.