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The Effect of 'Qiyao Xiaoke Oral Liquid' on Erectile Dysfunction in Men With type 2 Diabetes: A randomized double-blind and placebo-controlled study

The Effect of 'Qiyao Xiaoke Oral Liquid' on Erectile Dysfunction in Men With type 2 Diabetes: A randomized double-blind and placebo-controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003023
Enrollment
Unknown
Registered
2012-11-26
Start date
2013-01-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Erectile Dysfunction

Interventions

Qi Yao group:with "Qiyao Xiaoke Oral Liquid" treatment
Placebo group:with placebo treatment

Sponsors

Tianjin Medical University Metabolic Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Males between 40~65 years old; 2. have a diagnosis of Type 2 diabetes mellitus for 5 years at least and 10 years at most; 3. have a performance of deficiency of both qi and yin syndrome; 4. have a HbA1c <=8.5% or FPG <=10.0 mmol/L or postprandial plasma glucose<=12.0 mmol/L after stable medical therapy that like bofore participating the study, controling diet and keeping exercise for 2weeks; 5. have a score between 8 to 21 of the IIEF.

Exclusion criteria

Exclusion criteria: 1. Anatomical abnormalities of the penis that could impair EF, hypoactive sexual desire, ED after spinal cord injury, history of radical prostatectomy; 2. Blood pressure (BP) 160/100mmHg; 3. Have a treatment for ED(including other medicine,physiotherapy, psychotherapy, health-care food and so on within the prior 1 months; 4. History of ketoacidosis, severe infection and traumatism, or capital operation in the previous 2 years; 5. Major cardiovascular, cerebralvascular, hematological, renal, or hepatic illness; 6. With a severe complication of diabetes mellitus like diabetic nephropathy and diabetic retinopathy; 7. Chronic disease of gastrointestinal tract or bad state of body like chronic malnutrition and dehydration; 8. Hypersusceptibility to the traditional Chinease medicine or used to be sensitive; 9. Any major psychiatric disorder; 10. Participating other clinical study; 11. History of alcohol,other psychoactive substances or drug abuse or dependence; 12. According to the judgment of researchers, it will reduce the possibility to participate the study or make the participating more complex, for example, change the work or living environment frequent; 13. the dosage and kinds of oral medicine for blood glucose,blood pressure or blood lipids cannot be stable.

Design outcomes

Primary

MeasureTime frame
International Index of Erectile Function;

Secondary

MeasureTime frame
Erection Hardness Grading Scale;Sexual Encounter Profile question 3;Treatmen Satisfaction Scale;Sexual hormone;glycolated hemoglobin;fasting blood glucose;2 hours postprandial blood glucose;blood lipids;traditional Chinese Medicine symptom score;

Countries

China

Contacts

Public ContactZhongming Wu
wuzhongming@tijmu.edu.com+86 13672093136

Outcome results

None listed

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