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A Exploratory Cross-Control Trial of Shaoyao Gancao Tang (Zhusan Decoction Pieces Extract Granules) in the Treatment of Muscle Cramps for Hemodialysis Patients

A Exploratory Cross-Control Trial of Shaoyao Gancao Tang (Zhusan Decoction Pieces Extract Granules) in the Treatment of Muscle Cramps for Hemodialysis Patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052982
Enrollment
Unknown
Registered
2021-11-07
Start date
2021-11-10
Completion date
Unknown
Last updated
2022-08-30

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

Conditions

Muscle Cramps in Patients with Maintenance Hemodialysis

Interventions

Group A:1-4 weeks of oral administration of Shaoyao Gancao Decoction (plain granules of boiled decoction pieces)
Group B:1-4 weeks as a blank control group
7-10 weeks of oral administration of Shaoyao Gancao Decoction (Zhisan Decoction Pieces Extract Granules)

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic kidney disease stage 5 and maintenance hemodialysis for more than 3 months; 2. Patients with dialysis times >= 2 times/week and muscle cramps >= 2 times/week (or >= 4 times in 2 weeks); 3. Aged 18 to 80 years(calculated according to the age when informed consent was obtained), those who signed the informed consent form; 4. Patients who can receive oral test drugs.

Exclusion criteria

Exclusion criteria: 1. Patients with serious complications (liver, heart, lung, blood, metabolic diseases or malignant tumors, etc.); 2. Patients with chronic cardiac insufficiency grade 3 (NYHA classification) or above; 3. Pregnancy and patients who may be pregnant; 4. Patients with combined hepatocellular carcinoma. However, if the disease is controllable after treatment, it does not constitute an exclusion condition; 5. Patients who have recently taken drugs related to muscle spasm (the washout period should be more than 2 weeks); 6. Patients who are considered to be unable to comply with the principles of alcohol abstinence during participation in this study; 7. Patients with a history of allergy to Kampo medicines; 8. Patients who are or plan to participate in drug clinical trials or other clinical studies; 9. Other patients who are considered inappropriate by the doctor in charge of the research or the doctor in charge of the research.

Design outcomes

Primary

MeasureTime frame
The improvement in the frequency of muscle cramps;

Secondary

MeasureTime frame
Degrees of pain during muscle cramps;blood routine examination ;liver function;renal function;Myocardial enzyme;Hypersensitive troponin ;Blood electrolyte;Electrocardiogram;

Countries

China

Contacts

Public ContactMao Wei

Guangdong Provincial Hospital of Traditional Chinese Medicine

maowei@gzucm.edu.cn+86 13808864963

Outcome results

None listed

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