Skip to content

Randomized double-blind placebo-controlled clinical trial on the efficacy and safety of Quan Duzhong Capsule in treating erectile dysfunction (kidney yang deficiency syndrome)

Randomized double-blind placebo-controlled clinical trial on the efficacy and safety of Quan Duzhong Capsule in treating erectile dysfunction (kidney yang deficiency syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000489
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

erectile dysfunction (kidney yang deficiency syndrome)

Interventions

Test group:Quan Duzhong Capsule
control group:Quan Duzhong Capsule Simulator

Sponsors

Qinghai Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Western diagnostic criteria for erectile dysfunction; (2) Meets the diagnostic criteria for kidney yang deficiency syndrome in traditional Chinese medicine; (3) Clinic blood pressure: 120mmHg = systolic blood pressure = 159mmHg and/or 80mmHg = diastolic blood pressure = 99mmHg; (4) Age between 18-60 years old (including boundary values) male; (5) The total score of IIEF-5 is between 12-21 points (including boundary values); (6) Having a fixed sexual partner and a stable sexual life and still expecting to maintain active sexual activity with the sexual partner during the study period; (7) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Researchers have identified clinically significant abnormalities in the anatomy or structure of the penis including but not limited to: small penis congenital curvature of the penis fibrosis of the corpus cavernosum of the penis etc; (2) Patients with this disease caused by other sexual dysfunction disorders (such as ejaculation disorders premature ejaculation) or incurable endocrine disorders (such as hyperprolactinemia hyperthyroidism/hypothyroidism Cushing's disease or pituitary dysfunction etc.); (3) Erectile dysfunction caused by spinal cord/nerve injury radical prostatectomy or other trauma surgery or radiation therapy; (4) According to the medical history there have been acute complications of diabetes (such as diabetes ketoacidosis hypertonic non ketotic diabetes coma lactic acidosis and hypoglycemic coma) or diabetes retinopathy diabetes nephropathy diabetes neuropathy diabetes foot and other complications; (5) Individuals with severe psychological factors or a history of mental system disorders or those who cannot guarantee discontinuation of anti anxiety and depression medications during the trial period; (6) Patients with combined urethritis acute prostatitis urinary tract stones and other diseases; (7) History of gastrointestinal surgery with significant changes in drug absorption distribution metabolism and excretion (such as gastrectomy gastrointestinal anastomosis or intestinal resection gastric bypass surgery gastrointestinal banding surgery etc.); (8) Individuals with severe cardiovascular and cerebrovascular diseases; (9) Patients with severe primary diseases or malignant tumors of the liver kidney hematopoietic system etc. (such as AST ALT or BUN = 2 times normal); (10) Individuals with allergic constitution or allergies to experimental drugs or their components; (11) Sexual partners who are breastfeeding pregnant or preparing for pregnancy or who have restricted sexual activity during treatment for gynecological diseases or who have serious systemic organic diseases affecting sexual intercourse; (12) Suspecting or having a history of alcohol or drug abuse or other lesions or conditions that based on the researcher's judgment reduce the likelihood of inclusion or complicate inclusion such as frequent changes in the work environment that can easily lead to loss to follow-up; (13) Individuals who have participated in clinical trials of other drugs within the past 3 months; (14) Those who are preparing to give birth during the medication period or after stopping medication for 3 months; (15) The researchers believe that there are any other factors that are not suitable for the subjects to enter this trial.

Design outcomes

Primary

MeasureTime frame
IIEF-5 score;

Secondary

MeasureTime frame
ET-1 NO NOS sVCAM-1 Ang?;HCY;TT\PRL\LH\FSH\E2;Traditional Chinese Medicine Symptom Score;;SOD MDA;EHS score;Clinic blood pressure;;

Countries

China

Contacts

Public ContactShen Jianwu

Qinghai Provincial Hospital of Traditional Chinese Medicine

0907shenjianwu@163.com13810419173

Outcome results

None listed

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