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Warning: Investigational use only, not available for sale.
Safety and Efficacy Not Yet Proven in Randomized, Double Blinded, Placebo Controlled Statistically Significant Controlled Clinical Trials.
Data from Early Feasibility Pilot Clinical Studies in China
Bioelectric Treatment High Blood Pressure (Hypertension)
Test Article = Jiajun hypertension depressor
Study Sponsor = Dr. Gao JiaJun – JiaJun Bio-electronics Institute.
Clinical early feasibility un-controlled pilot studies at the provincial capital hospitals in Beijing, Shanghai, Liaoning, Jilin, Hebei and Guangdong show that bioelectric treatment of hypertension is:
- 98% effective for the first-stage hypertension;
- 93.5% effective for the second-stage hypertension;
- 90% effective for the third-stage hypertension;
- 97% effective for hypertensive headache.
Clinical Pilot Studies in China Treatment for High Blood Pressure (Hypertension)
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Treatment effect observation report of Jiajun Hypertension Depressor
I. Target Observe and evaluate the precise treatment effect of Jiajun hypertension depressor, Including instant blood pressure degrading and the blood pressure status after one month. The evaluation is emphasized in the treatment effect of instant blood pressure degrading of Jiajun hypertension depressor. II. Solution
1. Observation We arranged two groups for observation. We chose 120 diagnosed hypertension patients from Beijing TianTan Hospital, Beijing No. 4 Hospital, and the Hypertension Administration Committee of ChongWen district Stadium Road Hospital and arranged them to the two groups, 60 persons in each group. One is the observation group, the other is the comparison group. The standard of our choose of the patients are: Volunteers, with SBP >=160mmHg, and/or DBP >=95mmHg, no obvious syndrome of heart, brain, and kidney.
2. Patients to be observed Among the 120 diagnosed hypertensives male are 53 persons, and female 67 persons. The average age is 66.61+-8.64 years old. (M+-SD) The average ill history of hypertension is 17.08+-11.02 years (M+-SD). The general introduction of the observation group and the comparison group see Table 1. The sex and age composition of the two groups are comparable.
Table 1. General introduction of observation group and comparison group
3. Training and quality control
Before observation, we trained the 11 observers (already trained in blood pressure measure for many times) in the scheduled observation target, operation and performance of mercury blood pressure meter, and operation and performance of Jiajun hypertension depressor. Of the 11 observers, 3 came from Beijing TianTan Hospital, 5 from Beijing No.4 Hospital, 3 from ChongWen district Stadium Road Hospital. And 5 quality control personals from Beijing Neurosurgery Research Institute carried on the overall quality control during the complete performance. 4. Blood pressure observation
Blood pressure observation took 4 weeks. On every Tuesday or Wednesday we conducted one inspection between 9:00am to 11:00am as scheduled. For the members of observation group it is supposed to take a rest of 5 – 10 minutes in peaceful status before treatment. Their blood pressure is measured twice professionally and noted down afterwards, and then the patients start the treatment with Jiajun hypertension depressor as required. After the treatment the patients are supposed to relax totally and sit calmly for 5 – 10 minutes, and again their blood pressure is measured twice and noted down. The members of comparison group are not required to use Jiajun hypertension depressor for treatment. Their blood pressure is also measured twice after a rest of 5 – 10 minutes. The members of observation group take the device home and do the treatment as required for 3 – 5 times every day. All members of observation group are not supposed to intake blood pressure degrading medication within 6 – 8 hours before treatment in the inspection days. 5. Operation of Jiajun hypertension depressor
5.1) Head comb: Hold the metal ring at the back of the device with one hand, and apply the three groups of metal pins tightly on the forehead of the patient with proper pressure, and comb in the middle upwards at the even speed of 1 – 2 times per minute and down the back of head. One treatment takes 3 – 5 minutes. 5.2) Hand touch: Hold the metal ring at the back of the device with one hand, and open the other hand naturally. Apply the tops of the three groups of metal pins against the paunch of fingertips tightly and hold for 3 – 5 minutes.
Either of the above two methods can be used, but better not to use them in turn, and the treatment should be taken every day. The observer is responsible to direct the patients to use the device correctly.
Of the 60 patients of the observation group, 35 persons chose the method of head comb, which takes 58.3% of the total members, and 24 chose the method of hand touch, which takes 40.0%. One person chose both methods of head comb and hand touch, which takes 1.7%.
III. Results
1. It is observed the obvious difference of blood pressure levels (P<0.01) of both SBP and DBP measured before and after treatment with Jiajun hypertension depressor, and in the initial measured group, 1st inspection group and the total group. See Table 2.
2. Comparing observation group with comparison group, it is found that there is no obvious difference of both SBP and DBP in different groups except SBP in the first inspection. But the blood pressure degrading of both SBP and DBP of the observation group is more than comparison group, comparing the forth inspection with the initial measured. Details see Table
3. The blood pressure of observation group measured in the last inspection in comparison with those measured initially, SBP degrades 9.83mmHg and DBP degrades 8.41mmHg. For the comparison group the degrading of SBP and DBP is respectively 5.77mmHg and 7.84mmHg.
Table 2. Blood pressure levels of observation group measured before and after treatment
Note: * P<0.05; ** P<0.01
3. Comparing the BP measured before inspections and after the last treatments, the BPs have certain upgrades, except the SBP measured before 1st inspection and the DBP measured before 4th inspection, but no difference. Details see Table 4.
Table 4. Blood pressure of observation group measured before 1st inspection and after treatment
4. Intakes of blood pressure degrading medication
During the observation, majority of the patients were taking blood pressure degrading medication, except 5 persons in observation group and 3 persons in comparison group. There is no obvious difference in both observation group and comparison group among the patients who increased, or made no change, or decreased the medication dosage, or stopped or changed the medication. Details see Table 5 and Table 6 Table 5. Medication intakes of observation group
Table 6. Midication intakes of comparison group
IV. Summary Our observation demonstrates that Jiajun hypertension depressor has obvious treatment effect of instant blood pressure degrading, and the treatment effect lasts long. Jiajun hypertension depressor, as a no wound, no obvious side effect, assistant blood pressure degrading device, can be promoted in more people.
Clinic Report (2)
Observation of 611 treatment cases with Jiajun hypertension depressor
In order to observe the treatment effect of Jiajun hypertension depressor, which is produced under the supervision of China Rural Hygiene Association, we conducted continuous treatment observation to 611 cases of hypertension for a period of 4 weeks. Our summary:
1. Patients to be observed We chose 611 hypertensives according to WHO 1978 hypertension diagnostic standard, among whom 330 are male, 281 female. Stage I hypertensive 333 persons, Stage II hypertensive 228 persons, Stage III hypertensive 33 persons, critical hypertensive 11 persons, and low blood pressure patient 6 persons. The ages are between 20 to 86 years old, and 53 years old in average. See Table 1 and Table 2.
Table 1. Groups in age
Table 2. History of illness
2. Observation
Patients use Jiajun hypertension depressor twice a day, 2 – 3 minutes each time. When using the device, patients must grasp the metal ring with fingers at the back of the device, and the optimum frequency of combing is 1 (one) time in a minute, moving from forehead upwards and down at the back. The metal pins should not be pressed hard against the skin to avoid hurting. In case the patient is helped by somebody, the helper should take the patient’s hand in one hand, and do the performance as mentioned above with the other hand. On Monday, Wednesday and Friday, in the morning and in the afternoon, before treatment and at the peaceful status, the patients’ blood pressure is measured twice and the average value is taken. Again 3 – 5 minutes after the treatment the patients’ blood pressure is measured twice and the average value is taken. The treatment effect is observed in this way and the performance is done by specially assigned people. 3. Judgment of treatment effect
3.1) The treatment effect after first week see Table 3 and Table 4. Table 3. SBP treatment effect
Altogether 528 patients have got their blood pressure degraded after using the device, among whom Stage I patient are 297 persons, Stage II 197 persons, Stage III 32 persons, and critical 2 persons. The degrade of SBP takes 88.44%, the degrade range from 1 – 10mmHg takes 79.2%, the degrade range over 11mmHg takes 20.8%.
3.2) Table 4. DBP treatment effect
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