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

Phase 1

Recruiting

• Conditions: myelodysplastic syndrom

• Registration Number: ITMCTR2000004040
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HI-N/HI-P;TCM syndrome;HI-E;SF-36;