Herose® Psoria Capsule  
 
Clinical Study
  1. A clinical study was done on 294 psoriasis patients in the Armed Forces Hospital of Inner Mongolia (People’s Republic of China) under the supervision of Dr. Tang.

  2. The psoriasis patients were treated from 1993 to 1999.

    The period of trial 1993-1999
    Psoriasis cases Male 136
    Female 116


    Figure 1


    Figure 2

  3. Methodology

    Design:
    The study was an open one conducted in one center. Patients were seen every month for duration of six months. 54 % of the patients were male, 46 % female.

    Patients:
    All patients were seen ambulatory, with a clinical diagnosis of chronic plaque psoriasis.
    Exclusion criteria were: severely inflamed psoriasis, treatment with other systemic anti psoriatic drugs, PUVA or UVB treatment, pregnancy, breast feeding and any debilitating disease which could affect the course of the treatment.

    Treatment:
    The patients were instructed to take five Herose® Psoria Capsules three times a day. For patients who have not previously took steroids or immunosuppressive drugs, the standard treatment duration was 3 months. For patients who have previously steroids or immunosuppressive drugs, the standard treatment duration is 9 months.

    Assessment of efficacy:
    At each visit the investigator assessed each patient’s psoriasis and response to treatment. Each response was graded as worse, unchanged, slight improvement, moderate improvement or marked improvement and clearance.

    In the final analysis, a worsening or an unchanged lesion is considered a failure, a slightly, moderately or markedly improved lesion a partial success and a full clearance of the lesion a success.

    Adverse events:
    Adverse event reports were elicited by general inquiry at all visits. Ten patients complained about adverse events namely headache, diarrhea, nausea, which were considered by the investigator not to be related to the study drug treatment received. None of the patients stopped the treatment because of these adverse events.

  4. Results

    Of the 294 patients initially enrolled in the study, 42 dropped out for various extraneous reasons, for example lack of quick result, long travel time to come to the clinic and migration to other parts of China.

    The patient age distribution is given in figure 1. The majority of patients were aged between 21 and 30 years. There were 81patients who were 18 years or below.

    As seen in figure 2, most of the patients had psoriasis for more then two years. One patient suffered from psoriasis for 38 years.

    Sixty-three patients had not previously taken steroids or immunosuppressive drugs (Group 1), while 189 patients had a history of intake of such drugs (Group 2).

    After 3 months of treatment, 60 patients in Group 1 (Figure 3) experienced a complete healing of their psoriasis lesions and no relapse was seen during the subsequent follow-up period of up to 8 years.

    In this group, about a week after the first intake of the capsules, new lesions ceased to appear and old lesions started to improve, until complete disappearance. Upon recovery, the (previously) affected skin area had a normal appearance and took on the color of healthy skin.

    After 9 months of treatment, 164 patients in Group 2 experienced a complete healing with no relapse during the subsequent follow-up period of up to 8 years. This worked out to an 87% success rate.

    In this group, after about 2 weeks of treatment, new lesions ceased to appear while after 1 month (of treatment), the old lesions reduced in size and become greyish.

    The improvements of the symptoms began in the lower limbs, gradually moving upwards during the course of the treatment. A small number of patients saw an improvement in all parts of the body at the same time.

    Ten patients complained about adverse events (headache, diarrhea, nausea) which were considered by the investigator not to be related to the study drug treatment received. None of the patients stopped the treatment because of these adverse events.

    The success rate percentage was the same in children as in adults. There was also no difference in success rate between men and women.

     
    Success
    Partial
    Success
    Fail
    Successful
    Rate
    Patients not previously treated with steroid or immunosuppressant
    60 Cases
    0 Cases
    3 Cases
    96%
    Patients previously been treated with steroid or immunosuppressant
    164 Cases
    0 Cases
    25 Cases
    87%
    Figure 3
  5. Discussion

    The results of this study show that the Herose® Psoria Capsule is an effective and safe treatment of moderate to serious psoriasis lesions. The long term success rate is high especially in the patients who previously did not take steroids or immunosuppressive drugs (96 % with no relapse).

    For patients who have previously been treated with immunosuppressive drugs, the success rate is slightly lower (87%) and the duration of treatment needed for recovery is determined by the amount and the type of the immunosuppressive drugs previously taken. Patients in this group took longer to obtain a full recovery (usually 9 months).

    The relapse percentage is also determined by the previous intake of steroids and immunosuppressive drugs.

  6. Conclusion

    Herose® Psoria Capsule is a very effective and safe treatment of moderate to serious plaque psoriasis. It can be used with the same success rate in children and in adults. There is also no difference in efficacy between the genders.

    The duration of treatment depends on the previous intake of steroids or immunosuppressive drugs, but should not usually not exceed 9 months. Further treatment is usually not necessary.

    Last but not least, the treatment has been used in one clinic in China for since 1971 and the accumulated experience demonstrates the safety of this treatment.

 

 

 
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