Content

A report of the results of clinical study of the biologically active peptide bioregulator of Thyroid origin Clinical Characteristics Of Patients Research Methods Research Results Conclusion Recommendations For Use

A report of the results of clinical study of the biologically active peptide bioregulator of Thyroid origin


The biologically active food supplement Thyroid Bioregulator is a complex of low molecular weight peptides with a molecular weight of up to 5000 Da, obtained from the thyroid gland of young animals – calves not older than 12 months of age or pigs. The isolated peptides have a tissue-specific effect on thyroid cells, restoring metabolism and normalizing their functional activity.

Nature’s Marvels Thyroid Bioregulator is produced in tablets or capsules containing 10 mg of active peptides.

The Thyroid Bioregulator was administered to patients orally 10-15 minutes before meals, 1-2 capsules 2 times a day for 20 days, depending on the severity of the pathological process. Clinical trials of Thyroid Bioregulator were carried out at the Medical Center of the St. Petersburg Institute of Bioregulation and Gerontology, SZO RAMS, in patients with primary hypothyroidism in the period from November 2005 to January 2006. Primary hypothyroidism is one of the age-related disorders of the thyroid gland.

In the pathogenesis of primary hypothyroidism, a change in the gland tissue or inhibition of the synthesis of thyroid hormones due to infectious diseases, trauma, or spontaneous destruction of the thyroid gland comes to the fore (3, 4).

Drug treatment of primary hypothyroidism includes the use of the following drugs (1, 2): – Thyroid hormones – thyroidin, thyroxine, triiodothyronine; – Vitamins B6, B12; – etc


Clinical Characteristics Of Patients

The study involved 25 patients with primary hypothyroidism, including 11 men and 14 women aged 56 to 67 years. The control group consisted of 19 patients, including 7 men and 12 women. Patients in both groups complained of rapid fatigue, drowsiness, memory impairment, frequent headaches, and dizziness. In most cases, signs of thyroid atrophy were detected by palpation. All patients previously received symptomatic therapy for the clinical manifestations of this disease. Patients in the control group were prescribed conventional means. In addition to conventional drugs, patients of the primary group received Thyroid Bioregulator 1-2 capsules 2 times a day before meals for 20 days.


Research Methods

The patients’ complaints were assessed in dynamics, a general clinical examination of blood and urine, and a biochemical study of blood on the REFLOTRON apparatus (Boehringer Mannheim, Germany) were carried out. Ultrasound examination of the thyroid gland was performed using an ultrasound machine (ALOKA, Japan), electrocardiography – using a CARDIOTEST EK-51 apparatus (Hellinge, Germany).
The content of hormones T3 and T4 in blood serum was determined by radioimmunoassay. The radioactivity of the samples was counted on a Tracor Analytic 1285 counter (USA-Holland).


Research Results

As a result of the studies, it was found that the use of Thyroid Bioregulator contributed to the improvement of the clinical manifestations of the disease in 78% of cases, and the most significant effect was observed in persons of the older age group with pronounced signs of thyroid atrophy. While taking Thyroid Bioregulator, the patients noted increased working capacity, decreased frequency and intensity of headaches, and decreased pain in the heart region.

Influence of the Thyroid Bioregulator on the level of thyroid hormones in bloodserum in patients with primary hypothyroidism:

In the study of objective indicators, normalization of ECG parameters was observed. Attention is drawn to the fact that the indicators of the secretory function of the thyroid gland remained at the achieved level for 3-5 months after the course of treatment with the use of Nature’s Marvels Thyroid Bioregulator. The restoration of the level of thyroid hormones within the physiological norm was noted (Table 1), which indicates a stabilizing effect of the drug on the cellular metabolism of the gland and a regulatory effect on metabolic processes. Thus, the obtained results of a clinical study of the drug indicate the effectiveness and appropriateness of the use of Nature’s Marvels Thyroid Bioregulator in the complex treatment and prevention of thyroid dysfunctions of various origins.

Clinical study of Nature’s Marvels Thyroid Bioregulator revealed no side effects or contraindications. The drug does not cause complications or drug dependence. The studied ready-made form of Nature’s Marvels Thyroid Bioregulator is convenient for inpatient, outpatient, and at-home use.

Nature’s Marvels Thyroid Bioregulator can be used for therapeutic and prophylactic purposes in the form of a biologically active food supplement as an adjuvant in combination with any means of symptomatic and pathogenetic therapy used to treat diseases caused by dysfunction of the thyroid gland of various origins.


Conclusion

The biologically active food supplement Nature’s Marvels Thyroid Bioregulator has a normalizing effect on the metabolism of thyroid cells. Nature’s Marvels Thyroid Bioregulator is well tolerated by patients when taken orally, has no side effects, has no contraindications, and can be used as a therapeutic and prophylactic biologically active food supplement.


References

1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. – M.: the Universe, 1993. — 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”, 1993.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.
4. Tepperman J., Tepperman H. Physiology of metabolism and the endocrine system: Translation from
English – M.: Mir, 1989. — 656 p


Recommendations For Use

Nature’s Marvels Thyroid Bioregulator is recommended to restore thyroid function in acute and chronic thyroid lesions. As a Prophylactic agent, it is advisable to use in areas endemic to thyroid diseases. It is also recommended for the elderly to maintain thyroid function.

The drug is taken 10-15 minutes before meals, 1-2 tablets or capsules 2 times a day for 20 days.
It is recommended to repeat the course of treatment in 3-6 months.
It is advisable to recommend Nature’s Marvels Thyroid Bioregulator for therapeutic and prophylactic use and industrial production.
Store in a dry place protected from light at a temperature of +2 to +25 oc.
Release form: 20 or 60 capsules of 0.2 g.
Expiration date: 5 years from the date of manufacture.