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Efficacy and safety of tamsulosin in medical expulsive therapy for distal ureteric stones: a multicentre, prospective, randomised, double-blind, placebo controlled clinical trial

Efficacy and safety of tamsulosin in medical expulsive therapy for distal ureteric stones: a multicentre, prospective, randomised, double-blind, placebo controlled clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001339
Enrollment
Unknown
Registered
2011-05-16
Start date
2011-05-01
Completion date
Unknown
Last updated
2017-06-05

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

Conditions

ureteric stones

Interventions

Group A:Harnal(Tamsulosin)0.4mg,orally take once daily for four weeks.pain relief therapy with diclofenac suppository on demand
Group B:2 capsule placebo orally take once daily for four weeks.pain relief therapy with diclofenac suppository on demand

Sponsors

Urological stone Group of Chinese Urological Association
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 60 years old; 2. distal ureteric stone; 3. stones were 4-6mm in diameter; 4. Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. ureteric stone with complications; 2. with a history of ipsilateral ureteric surgery, spontaneous stone expulsion; 3. pregnant or breast-feeding patients; 4. More than twice higher than normal liver and kidney function; 5. known or suspected allergy to one of the study medications; 6. current use of alpha-adrenoceptor antagonists, beta blockers, calcium channel blockers or corticosteroids; 7. presence of fever, UTI, Pyonephrosis; 8. severe hydronephrosis,renal insufficiency, Renal atrophy; 9. solitary kidney, urethrostenosis,ureteric stricture; 10. gastric ulcer, diabetes mellitus, hypotension, blood disease; 11. Alcoholics, drug addicts; 12. Doctors think that patients not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
overall stone expulsion;

Secondary

MeasureTime frame
pain relief situation;mean analgesic consumption for renal colic recurrence;The rate of surgical intervention;mean stone-expulsion time;

Countries

China

Contacts

Public ContactZhangqun Ye
zhangqun_ye@yahoo.com.cn+86 13507191761

Outcome results

None listed

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