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Clinical Study of Tiaogan Yiqi Dingji Formula on Tachyarrhythmia

Clinical Study of Tiaogan Yiqi Dingji Formula on Tachyarrhythmia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069953
Enrollment
Unknown
Registered
2023-03-30
Start date
2022-06-30
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tachyarrhythmia

Interventions

Case series:No
Single arm:Tiaogan Yiqi Dingji Formula

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria of retrospective study 1. cases that can be diagnosed as tachyarrhythmia; 2. case data showed that the patient was treated with Tiaogan Yiqi Dingji Formula for more than 4 weeks 3 Age 18-75 years old; 4. Unlimited gender; 5. the case has complete case data and dynamic electrocardiogram examination results before and after taking the medicine. Inclusion criteria for prospective studies 1. Meet the diagnostic criteria of Western medicine for tachyarrhythmia; 2. Hamilton Depression Scale (HAMD) 17 item score 7-24 points or (and) Hamilton Anxiety Scale (HAMA) 14 item score 7-21 points; 3. Meet the diagnostic criteria of palpitation (liver depression and qi stagnation, heart deficiency and cowardice syndrome) in traditional Chinese medicine; 4. age 18-75; 5. unlimited gender; 6. the subjects were informed and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria of retrospective study 1. Those who take other prescriptions or adopt other traditional Chinese medicine treatment methods during the treatment,or have other factors to interfere and cannot determine whether the prescription treatment is effective. 2. if the case is a pregnant, pregnant or lactating woman or complicated with serious mental disorders; Compliance with any of the above items can be excluded. Exclusion criteria for prospective studies 1. transient tachyarrhythmia caused by cigarette, alcohol, coffee, fatigue, infection, fever, anemia, drug-induced electrolyte disorder (such as low blood potassium). 2. it is hereditary arrhythmia, tachyarrhythmia and severe heart attack , ventricular premature beat with short duration of tachycardia = 30s), torsade de pointe, etc; 3. those who have non drug antiarrhythmic indications such as catheter ablation and cardioversion,and are willing to operate. 4. Pacemaker implantation or perioperative patients; 5. Acute myocardial infarction, severe cardiac insufficiency (NYHA cardiac function grade III, IV or lvef= 24 points or (and) Hamilton Anxiety Scale (HAMA) 14 item score >= 21 points, with suicide attempts or suicidal tendencies (HAMD item 3 score >= 2 points); 8. patients with obvious hemodynamic disorder, syncope, hypotension and shock; 9. those who are unable to cooperate due to serious mental disorders or other reasons; 10. Patients with severe primary diseases and dysfunction of liver, kidney, hematopoietic system, etc; 11. Pregnant, pregnant or lactating women; 12. those who have participated in other clinical trials in recent 3 months. Compliance with any of the above items is excluded.

Design outcomes

Primary

MeasureTime frame
Frequency and duration of tachyarrhythmia;Holter;

Secondary

MeasureTime frame
Therapeutic effect of TCM syndromes;Depression/anxiety score;Summary health status survey (SF-36) quality of life score;Pittsburgh Sleep Scale;

Countries

China

Contacts

Public ContactZhang Jingchun
zhangjingchun276@126.com+86 18601292386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026