Clinical Trials

Summary

Theraflax is used as a food supplement for patients with different forms of psoriasis. Theraflax is a well-balanced combination of essential fatty acids (EFAs) and other fatty acids, derived from different plant species; which, according to the producers contains the optimal content of polyunsaturated fatty acids. 

Psoriasis is one of the most often occurring dermatological disorders, affecting more than 2% of the world population. Psoriasis is a chronic-relapsing skin disease based on genetic predisposition and exogenous provocation covering all areas of the body, including the nails and joints. 

Theraflax was developed on the premise that:

  • The introduction of polyunsaturated fatty acids in everyday diet is used as a psoriasis therapy, which is derived on the epidemiological characteristics of the disease.
  • The proper everyday intake of essential fatty acids could change the lipid surrounding of membrane proteins, thus modulating their conformation and activity.
  • That essential polyunsaturated fatty acids influence the skin metabolism as well as the function of other human organs and systems. 


Based on the preliminary observations and theoretical presumptions it was assumed that Theraflax might have a beneficial effect on psoriatic symptoms. The clinical observation of Theraflax was done at the Dermatological department of the Medical Faculty - Sofia.
 

  • The observation objective presumed a beneficial effect of Theraflax on patients with different forms of psoriasis, who were instructed to take only the supplement for a minimum of 6 months.
  • Participants were allowed to apply indifferent emollients as well (Linola Fett- Dr Wolff; Excipial Hydrolotio- Spirig; ex tempore prepared cold crème containing vaselin, lanolin and aqua calcis in equal quantities).
  • The criteria were patients with chronic relapsing psoriasis, psoriatic arthritis or erythrodermia psoriatica and history of psoriasis for at least 2 years.
  • All patients took 20 ml Theraflax daily, divided into two equal doses in the morning and in the evening.

The follow-up period extended for 6 months as the patients underwent three obligatory clinical examinations – on the 30th, 90th day and at the end of the 6th month.

Trial Conclusions

  • Results indicated that Theraflax has an excellent effect on the pain symptoms in patients with psoriasis arthropathica.
  • Self evaluation of participants suffering from Psoriatic Arthritis reported an average 85% reduction in pain severity and improvement of the condition during the course of the study.
  • Self evaluation of participants reported an average 40% reduction in lesions, scaling, and itchiness during the course of the study (PASI).
  • Most of the patients claimed effective beneficial response in the first 10 days of the initiation of the treatment.
  • This result confirms the prediction that Theraflax may be an effective natural method for alleviating the pain symptoms compared with the multiple adverse effects of the anti-inflammatory and immune-modulating drugs used today.

Recommendations

  • Theraflax should be administered together with Vit B3, B6, Vit C and microelements Mg and Zn, which exert a synergetic effect on its metabolism. This will improve the effectiveness of Theraflax in combating the symptoms associated with Psoriasis.
  • Alcohol, sugar and excessive saturated fatty acid intake could reduce the utilization of polyunsaturated fatty acids; therefore their concomitant intake should be avoided to help improve the effectiveness of treatment with Theraflax.
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