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NCT02583802
The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients by Ear Pills Combined With Shengmai Capsule
Phase 2/Phase 3 trial testing Ear pills in Intradialytic Hypotension in 150 participants. Status unknown.
1 October 2015
Quick facts
| Lead sponsor | Beijing University of Chinese Medicine |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 September 2013 |
| Primary completion | 1 October 2015 |
| Estimated completion | 1 December 2015 |
| Sites | 1 location across China |
Drugs / interventions tested
- Ear pills — full drug profile →
- Shengmai capsule — full drug profile →
Conditions studied
- Intradialytic Hypotension — all drugs for Intradialytic Hypotension →
Sponsor
Beijing University of Chinese Medicine
Who can join
Adults 18 to 80, any sex, with Intradialytic Hypotension. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The measurement of blood pressure
Time frame: 8 weeks
According to the diagnostic criteria of hypotension in hemodialysis patients， To summarize the incidence of hypotension in the experimental group and the control group.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02583802
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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- NCT07033273 — Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension · recruiting
- NCT05834777 — Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor · Phase 3 · recruiting
Other Beijing University of Chinese Medicine trials
Trials by the same sponsor.
- NCT06980636 — A Trial of Shengmai Liquid for Long COVID Fatigue. · Phase 4 · recruiting
- NCT07472777 — Long-term Efficacy of Modified Guilu Erxian Glue for Myasthenia Gravis · completed
- NCT05941598 — Electroacupuncture for Chemotherapy-Related Cognitive Impairment · Phase 2 · unknown
- NCT05508815 — Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis · EARLY_PHASE1 · unknown
- NCT03759405 — IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure · Phase 2, PHASE3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02583802 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing University of Chinese Medicine
- Last refreshed: 21 October 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02583802.
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