Clinical trials had been conducted at the independent medical institutions during ten years with the aim to confirm effectiveness of Frolov’s training device.

Federal State Institution Scientific Centre of Restorative Medicine and Balneology Roszdrav, Scientific Centre of Restorative Medicine, Moscow, Khan M.A.

Clinical trial “Application of an individual inhaler-training device in cases of breathing disorders and vegetal vascular dystonia in children”

Clinical trials and special tests were performed among 29 children with bronchial asthma from slight to middle severity and 31 children with acute (common) obstructive and recurrent bronchitis aged from 6 to 16 years old. From this group 40 children had a course of diaphragm breathing on the individual inhaler-training device, 20 children were included into the control group , comparative with the clinical symptoms and functional data ( within training on device).

Procedures were prescribed to the patients with bronchial asthma in the period of unstable remission and in periods between asthma attacks, and in patients with acute obstructive and intermittent bronchitis in remission periods. There were no side effects during the trainings.

Clinical observations and special methods of investigation were performed among 60 children with vegetative vessel dystonia of hypotonic and hypertensive types at the age of 6 to 16, 40 children had training on the individual inhaler-training device, 20 children were included into the control group (without physiotherapy).

Summary

As the result of the performed investigations was found that the breathe training on the individual inhaler-training device had positive influence on the clinical course of the illnesses mentioned above. The clinical effectiveness and usefulness of individual inhaler-training device produced by the “Dinamika” company was conformed during performed clinical trials in patients with bronchial asthma, acute (common) obstructive and recurrent bronchitis, vegetative vessel dystonia of hypotonic and hypertensive types in children and teenagers.

Breath training with the individual inhaler-training device has a complex influence on the restoration of cardiac and breathing systems functions. It was found that it has an improving influence on the vessels and bronchus tonus due to the positive changes in functional relationships between different parts of vegetative nervous system , significant improvement of local lymph and blood circulation ( also cerebral circulation), and as the result diminishing of headache symptoms, reducing of vegetative complaints ( cardiac, gastro-intestinal, psycho-vegetative, etc.), stabilization of the heart rate and blood pressure parameters, improvement of bronchus permeability, decreasing of plasma immunoglobulin misbalance and peripheral blood parameters, improvement of the local immune state.

The most important results of an individual inhaler-training application are hypoxemia and hypercapnia with the vasodilating effect on arterial and capillary spasm, improving of capillary circulation, leading to the maximal oxygen metabolism in tissues and organs. Diaphragm type of breathing helps to regulate intrathoracic and abdominal pressure, enforcing circulation and heart outcome.

High effectiveness of a diaphragm breathing with the individual inhaler-training device produced by the “Dinamika” company, good tolerance of the procedures could be a recommendation of application of this method at all stages of the restorative treatment of children with bronchial asthma, acute (common) obstructive and recurrent bronchitis, vegetative vessel dystonia of hypotonic and hypertensive types ( in clinic, polyclinic, rehabilitation centre, sanatorium).

M.D, professor, Head of Russian Department of Restorative Medicine and Balneology, Roszdrav, Leading Pediatric Specialist in Restorative Medicine and Balneology of the Moscow Healthcare Department, Khan M.A.

Clinic of Scientific Centre of Clinical and Experimental Medicine Siberian Branch of the Russian Medical Academy

Clinical trial protocol of the individual inhaler-training device produced by the “Dinamika” company (Novosibirsk)

From July 10, 2004 till August 25, 2004 at the Clinic of Scientific Centre of Clinical and Experimental Medicine Siberian Branch of Russian Medical Academy clinical trial of individual inhaler-training device produced by the “Dinamika” company were performed.

There are three procedures that functionally united in this device : breathing training device with possible regulation of breath resistance in the phase of inhalation and exhalation, inhaler of water solutions and medical plants , and the device for aromatherapy.

Presented device has a difference with the other training devices having a special containers for three essential oils, that were separated from a water phase of inhaler, during the inhalation components of inhaled solution and essential oils didn’t mix, it helps to achieve maximal biological effect and prevent synthesis of uncontrolled chemicals in liquid phase under high temperature.

Application of the stepped regulator of pressure support in device enlarges effectiveness of provided therapy.

78 patients with different illnesses included chronic nonspecific lung disease, acute and chronic bronchitis, arterial hypertension, and angina pectoris at the stage of remission and exacerbation, took part in the clinical trial in polyclinic and clinic.

Good therapeutic effect and possible combination with other physiotherapy and medicamental methods of treatment was mentioned, amplification of medicine effects and reduction of the treatment terms.

Summary

Individual inhaler-training device produced by the “Dinamika” company could be recommended for serial production.

Head of Pulmonology Department, MD, PhD Dr.Bahtina N.P.

Municipal Clinic #85 Federal Institution “Medbioextrem” Ministry of Health of Russian Federation, Novosibirsk

Clinical trial protocol of individual inhaler-training device produced by the “Dinamika” company (Novosibirsk)

Clinical trials of the individual inhaler-training device produced by the “Dinamika” company (Novosibirsk) thereafter named “Inhaler” were performed on the base of Functional Diagnostics Department and Physiotherapy of Municipal Clinic #85 Federal Institution “Medbioextrem” Ministry of Health of Russian Federation. Reason for clinical trial performance —resolution of Commission of devices and apparatus, applied in Pulmonology and for breathing metabolism and blood gases research of the Committee of a new medical technique MH and SD RF from June 18, 2004, Protocol #3.

Clinical trials summary

  1. Inhaler is easy in use, could be applied by patient independently at home, after reading manual or medical training.
  2. The advantages of Inhaler: a) small weight and size b)it is possible to use essential oils in combination and separately c)it is possible to use the device as inhaler with essential oils, and as training breathing device with breath resistance at the phase of inhalation and exhalation, d) it has stepped bottom of aerosol camera helping gradually regulate resistance at the phase of inhalation and exhalation depending on the liquid level in the camera, e) it is possible to apply device both as breath training device and as inhaler.

Head of Physiotherapy Department Municipal Clinic #85 Medvedeva T.I.

Head of Functional Diagnostics Department Municipal Clinic #85, Associate professor, Struchkov P.V.

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Municipal Prenatal Centre, Novosibirsk

Clinical trial protocol of individual inhaler-training device produced by the “Dinamika” company (Novosibirsk)

From July 15, 2004 till August 26, 2004 at the Municipal Prenatal Centre clinical trial of individual inhaler-training device produced by the “Dinamika” company were performed.

Summary

Inhaler has a triple action and could be used as a breath training device with the regulation of breath resistance at the phase of inhalation and exhalation, as inhaler of water solutions and medical plants solutions, and as a device for the aromatherapy.

Presented device has a difference comparing with the other training devices having a special containers for three essential oils, that were separated from water phase of inhaler, during the inhalation components of inhaled solution and essential oils didn’t mix, it helps to achieve maximal biological effect and prevent synthesis of uncontrolled chemicals in liquid phase under high temperature.

In addition, application of the stepped regulator of pressure support (resistance) enlarges effectiveness of provided therapy.

291 inhalations were performed among 73 patients with different diseases in polyclinic. List of diseases included: chronic nonspecific lung disease, acute and chronic bronchitis, arterial hypertension, and angina pectoris at the stage of remission and exacerbation, vegetative vessel dystonia, chronic inflammatory diseases of pelvis minor organs. It was found evident a positive clinical effect and possible combination with other physiotherapy and medicamental methods of treatment. Amplification of medicine effects and reduction of the treatment terms was mentioned.

Head of Physiotherapy Room, Dr. Lozovskaya V.P.

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Moscow State Medical-Dentistry University, Moscow

Rationale for application of individual inhaler-training device in system of rehabilitation

Rationale for application of individual inhaler-training device in rehabilitation of patients with breathing organs diseases (acute and chronic bronchitis, bronchial asthma, pneumonia), vegetative vessel dystonia of hypertensive and hypotensive types.

Clinical trial of the individual inhaler-training device was performed on the base of Department of Therapeutic Physical Training, Sport Medicine and Physiotherapy of Moscow State Medical-Dentistry University in Municipal Clinic #15. We had examined 37 patients ( 21 female and 16 male) with breathing organs diseases in acute, sub acute stage and stage of remission (acute and chronic bronchitis, bronchial asthma, pneumonia), vegetative vessel dystonia of hypertensive and hypotensive types).

Summary

Application of individual inhaler-training device is effective in cases of different breathing system pathology and could be recommended for the application in complex therapy in the hospital, in periods of rehabilitation in polyclinic and sanatorium-and-spa treatment, and at home. Also it could be used for training of the functional capacities of an organism and forming of proper breathing pattern in healthy people during the trainings in medical exercises dispensary, sports and fitness complex and medical centers.

Head of Department of Therapeutic Physical Training, Sport Medicine and Physiotherapy, Honored Science Worker, Doctor of Medical Science, professor, Dr. Epofanov V.A.

Head of Learning Activity Department, Ph.D., associated professor, Dr. Baukina I.A.

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Municipal Institution of Healthcare Municipal Clinical Hospital #2, Novosibirsk Department of Hospital Therapy NSMA

Clinical trial protocol of individual inhaler-training device produced by the “Dinamika” company (Novosibirsk)

From July 15, 2004 till August 26, 2004 at the Municipal Institution of Healthcare Municipal Clinical Hospital #2 clinical trial of individual inhaler-training device produced by the “Dinamika” company were performed.

320 inhalations were performed among 83 patients with different diseases in polyclinic. List of diseases included: chronic nonspecific lung disease, acute and chronic bronchitis, arterial hypertension, and angina pectoris at the stage of remission and exacerbation, vegetative vessel dystonia, chronic inflammatory diseases of abdomen and kidneys, musculoskeletal system.

Summary

While application of individual inhaler-training device good clinical effects, amplification of medicine effects and the reduction of treatment terms were found. It should be mentioned that possible combination with other physiotherapy and medicamental methods of treatment are possible with this device.

Head of Physiotherapy Department Dr.Artushin V.A.

Professor of Department of Hospital Therapy of Novosibirsk Medical Academy, Dr.Zyjbina L.Yu.