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Randomized double-blind control clinical study of lower-risk myelodysplastic syndrom (kideny Yang Deficiency) of compound Shenlu granule

Randomized double-blind control clinical study of lower-risk myelodysplastic syndrom (kideny Yang Deficiency) of compound Shenlu granule

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004040
Enrollment
Unknown
Registered
2020-08-31
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

myelodysplastic syndrom

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-80 years (calculated by date of birth); (2) The diagnostic criteria of MDS in Vienna in 2006 were met, (3) IPSS risk score was low / medium risk-1 (<= 1.0), and ipss-r was extremely low-risk / low-risk / medium risk (<= 3.5); (4) Patients who met the diagnostic criteria of kidney yang deficiency syndrome; (5)HGB<100g/L; (6) No other drugs that may affect hematopoietic function were used for 3 months or more; (7) The subjects were volunteers and informed consent was signed.

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating women; (2) Those with allergic constitution are allergic to the test drug or its related drugs or ingredients; (3) Patients with severe primary diseases such as heart, cerebrovascular, liver and kidney diseases; (4) Patients with severe liver function damage had ALT or AST >= 1.5 times of the upper limit of normal value; (5) In patients with severe renal impairment, serum creatinine was more than 1.5 times of the upper limit of normal value; (6) Mental illness patients who can't cooperate with each other; (7) Those who are participating in other clinical trials or have participated in other drug clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
HI-N/HI-P;TCM syndrome;HI-E;SF-36;

Countries

China

Contacts

Public ContactWeiYing Qu

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

81333701@qq.com+86 18018661862

Outcome results

None listed

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