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Intradialytic HypotensionPhase 2/3NCT02583802

The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients

A Phase 2/3 study testing Ear pills and Shengmai capsule in people with Intradialytic Hypotension, run by Beijing University of Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical study is to observe the improvement of MHD (maintenance hemodialysis) patients, quality of life,after applying therapy combining Auriculotherapy and Shengmai capsule. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Intradialytic Hypotension
What is being tested?
Ear pills and Shengmai capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Sep 2013to Dec 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • in the blood purification center hemodialysis (2-4 times / week, the same below) more than 3 months;
  • in line with the deficiency of both qi and Yin syndrome score greater than or equal to 9 points and thirsty XQ scores greater than or equal to 8 points; or deficiency of both qi and Yin syndrome score greater than or equal to 9 points and dialysis hypotension occurred frequency is greater than or equal to 1 / 5 of dialysis patients;
  • between 18-80, the condition is basically stable;
  • have better treatment compliance, signed informed consent.

Who cannot join

  • patients in the blood purification center of the law for less than 3 months.
  • the treatment of Chinese and Western medicine treatment of poor compliance.
  • infection, fever, acute heart failure or diabetes and blood glucose control is not ideal.
  • the patients with the capsule preparation and adhesive tape skin allergy.
  • patients unable to cooperate or not sign the informed consent.

Trial locations and contacts

1 site in 1 country.

Beijing University of Chinese Medicine Beijing University of Chinese Medicine contact

csdoctor1988@163.com

Beijing University of Chinese Medicine Beijing University of Chinese Medicine contact

China1 site, 1 recruiting
  • Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100029

    Beijing University of Chinese Medicine, csdoctor1988@163.com

    Recruiting

Other trials in China

About this study

Official title: The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients by Ear Pills Combined With Shengmai Capsule

This clinical study is to observe the improvement of MHD (maintenance hemodialysis) patients, quality of life,after applying therapy combining Auriculotherapy and Shengmai capsule. As a compliment to each other, Traditional Chinese Medicine and Modern Medicine form a joint and help improving life quality of MHD patients. Through the therapy, MHD patients, symptoms of thirst are improved, the incidence of intradialytic hypotension is reduced, the intake of water and sodium is lessen and the weight gain during dialysis is controlled, which consequently reduce cardiovascular and cerebrovascular complications and eventually reduce the mortality of MHD patients. Aiming to improve patients, thirst symptom and reduce the incidence of intradialytic hypotension, this study prospectively followed 144 MHD patients using multicenter prospective randomized crossover controlled clinical studies, using KT/V, URR, improvement of thirst, blood pressure and cognitive assessment as observational index. Multiple questionnaire surveys are conducted to understand patients, life quality from different angle. The use of Auriculotherapy is simple and effective and Shengmai capsule conforms to patients, syndrome, which is consistent with TCMs principle of "syndrome differentiation and treatment"and the theory of preventive treatment. The study not only expends the use of TMC in hemodialysis treatment, but also suggests a set of easy therapeutic schedules to improve the quality of life in patients receiving hemodialysis treatment.

Read the detailed description

3.1 research object 3.1.1 case: 3.1.1.1 Beijing University of Chinese Medicine Dongzhimen hospital 48 cases 3.1.1.2 54 cases of Oriental Hospital of Beijing University of Chinese Medicine 3.1.1.3 Chinese Academy of traditional Chinese medicine, Wangjing Hospital, 20 cases 3.1.1.4 28 case of Beijing Pinggu Hospital of Traditional Chinese Medicine 3.1.2 diagnostic criteria: 3.1.2.1: syndrome score standard: according to the traditional Chinese medicine clinical research guiding principle (2002), chronic renal failure syndrome of deficiency of both qi and Yin compiled score table and determine the inclusion criteria.

Diagnostic criteria of hypotension in 3.1.2.2:

Referring to the Ministry of health of the people's Republic of China promulgated the "blood purification standard operating procedures (2010 Edition)" in the "blood dialysis hypotension prevention and control standards for the prevention and control of standard operating procedures", the diagnostic criteria are as follows: (1) can be diagnosed: (1) systolic blood pressure reduction of more than 20mmHg; (2) the average arterial pressure decreased more than 10mmHg.

3.1.2.3 mouth thirst intensity score The investigators will mouth thirst intensity score table (XQ) eight problems in the translation into Chinese questionnaire, each question by visual rating scale method and by the patients according to their own scoring. The higher score indicated the mouth thirst more serious or mouth thirst caused discomfort heavier, and the summation of the scores of each question and convert it to a range of 0 to 100 score, resulting score higher mouth thirst more serious degree.

3.1.4.2 on the treatment of Chinese and Western medicine treatment of poor compliance.

3.1.4.3 infection, fever, acute heart failure or diabetes and blood glucose control is not ideal.

3.1.4.4 for the preparation of the capsule and the skin allergic patients with adhesive tape.

3.1.4.5 patients can not cooperate or not sign the informed consent. 3.1.5 removing and dropping standard 3.1.5.1 all cases that are not included in the criteria for inclusion in the inclusion criteria shall be excluded; 3.1.5.2 clinical information is not the whole case to be removed. 3.2 case grouping method This research is to set up experimental group (Western medicine routine + acupoint therapy combined with birth control group) and the control group (Western medicine group). To meet the inclusion exclusion criteria of the subjects, using random number table method to produce random sequence number, according to the random sequence number to the subjects were assigned to different treatment groups.

3.3 treatment method and treatment The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks. Experimental group on regular hemodialysis based on given auricular therapy selected export sympathetic endocrine, God door, massage time for about 1 minute, 3 ~ 5 times / day, each taking one side ear, 3 ~ 7 days take on the other side of the ear; Shengmai capsules and Shengmai Capsules (ChiaTai Qingchunbao Pharmaceutical Co., Ltd., Chinese medicine quasi word Z33021036, every grain of 0.3g. Ingredients: ginseng, ophiopogon root, Schisandra 3 capsules / time, 3 times / day. Control group received regular hemodialysis treatment, completed in the treatment of the first stage. After 4 weeks after a washout period, two groups of cross accept the next phase of treatment.

3.5 observation index 3.5.1 safety index: Into the group, crossover trial and the end of the experiment were used to detect the blood routine hemodialysis patients, before and after dialysis and renal ion, and serum albumin.

3.5.2 evaluation index:

  1. and KT/V: and URR were measured in the clinical observation of the biochemical, dialysis, and body weight at the end of the biochemical, dialysis, and weight gain of hemodialysis and Improvement Center. URR = (BUN) /BUN (BUN = 100%) + (4 *) + (3.5 * R) * KT/V (R = R) (BUN = 0.03) (LN = UF/W) (BUN =).
  2. thirst improvement: combined with clinical experience, thirst was divided into eight levels (combined with patients' self perception and thirst intensity score), making a thirst scale, in the group, when the end of the experiment and the end of the experiment, respectively, to observe the improvement of thirst before and after treatment.
  3. on the basis of the analysis of the improvement of the low blood pressure (first): according to the diagnostic criteria of hypotension in hemodialysis patients, the incidence of hypotension in the experimental group and the second stage was compared with that of the experimental group and the control group.
  4. the quality of life improvement in dialysis patients: in the clinical observation, the patients were treated with in-depth interviews, the use of key data extraction methods, to reflect the quality of life of patients with dialysis information; in the clinical observation of the patients, the cross exchange and the end of the life quality of SF-36 patients.
Being tested
Ear pills, Shengmai capsule
Keywords
MHD, ear pills, Shengmai capsule, Chinese medicine treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ear pillsDrug

    The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks. After 4 weeks after a washout period, two groups of cross accept the next phase of treatment.

  • Shengmai capsuleDrug

    The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks.

Study groups in NCT02583802
Study groupRoleWhat they receive
Control groupNo interventionControl group received regular hemodialysis treatment, no given Ear pills and Shengmai capsule completed in the treatment of the first stage. After 4 weeks after a washout period, two groups of cross accept the next phase of treatment.
Ear pills and Shengmai capsuleExperimentalOn regular hemodialysis based on given auricular Ear pills and Shengmai capsule
Receives: Drug: Ear pills; Drug: Shengmai capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The measurement of blood pressure

    According to the diagnostic criteria of hypotension in hemodialysis patients, To summarize the incidence of hypotension in the experimental group and the control group.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02583802
Sponsor's protocol ID
2013-ZYLC-003
Status last verified
Oct 2015
First submitted
13 Oct 2015
Last updated
22 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.

    PubMed 11395238
  • Jabbari S, Kim HM, Feng M, Lin A, Tsien C, Elshaikh M, Terrel JE, Murdoch-Kinch C, Eisbruch A. Matched case-control study of quality of life and xerostomia after intensity-modulated radiotherapy or standard radiotherapy for head-and-neck cancer: initial report. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):725-31. doi: 10.1016/j.ijrobp.2005.02.045.

    PubMed 16199308
  • Lin A, Kim HM, Terrell JE, Dawson LA, Ship JA, Eisbruch A. Quality of life after parotid-sparing IMRT for head-and-neck cancer: a prospective longitudinal study. Int J Radiat Oncol Biol Phys. 2003 Sep 1;57(1):61-70. doi: 10.1016/s0360-3016(03)00361-4.

    PubMed 12909216
  • Pacholke HD, Amdur RJ, Morris CG, Li JG, Dempsey JF, Hinerman RW, Mendenhall WM. Late xerostomia after intensity-modulated radiation therapy versus conventional radiotherapy. Am J Clin Oncol. 2005 Aug;28(4):351-8. doi: 10.1097/01.coc.0000158826.88179.75.

    PubMed 16062076

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ear pills and Shengmai capsule in people with Intradialytic Hypotension, run by Beijing University of Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Beijing University of Chinese Medicine Beijing University of Chinese Medicine (csdoctor1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The measurement of blood pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02583802, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.

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