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Clinical Study and Mechanism Exploration on the Treatment of Erectile Dysfunction with Huashi Tongbi Prescription

Clinical Study and Mechanism Exploration on the Treatment of Erectile Dysfunction with Huashi Tongbi Prescription

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066848
Enrollment
Unknown
Registered
2022-12-20
Start date
2022-12-20
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Erectile Dysfunction

Interventions

Treatment group:Take Huashi Tongbi Prescription,1 bag/time, 2 times/day
Control group of volunteers without ED diagnosis:NO

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria of organic ED: ?Under enough sexual stimulation, the penis can not achieve or maintain enough erection to complete sexual life satisfactorily; ?The course of disease lasts for 3 months or more; ?Patients with organic ED after AVSS-Rigiscan detection; ?IIEF-5 score = 21. Refer to the 2016 edition of Integrated Chinese and Western Medicine Diagnosis and Treatment Guide for Erectile Dysfunction (Trial Version), Guiding Principles for Clinical Research of New Chinese Medicines (2002 Edition): TCM Dialectical Standard of Dampness heat Spleen Accumulating ED: (1)Main symptom: Penis flaccidity without lifting and (or) penis lifting without firmness; (2)Secondary disease:?Loose stools; ?Abdominal distension; ?Limb strangulation; ?Scrotal dampness; ?Body heat without rising; ?Be thirsty and drink less; ?Listlessness; ?Poor morning erection; (3)Tongue and pulse: Lingual redness and yellow and greasy tongue coating, rolling and rapid pulse or floating and rapid pulse. Notes: With the main symptom, tongue and pulse, two secondary symptoms can be diagnosed as damp heat accumulating spleen type ED. Case inclusion criteria (1) Conform to ED diagnostic criteria; (2) Conform to the dialectical standard of TCM; (3) AVSS erectile function test is negative; (4) IIEF-5 score = 21; (5)22 = age = 50 years old; (6) Having a regular sexual partner and regular sexual life, having sex at least once a week, and being able to cooperate in completing this study; (7)No birth planner during the study period and within three months after the completion of the study; (8) Voluntary signing of informed consent. Inclusion criteria of volunteers without ED diagnosis: (1)AVSS erectile function test is positive; (2) IIEF-5 score =22; (3)22 = age = 50 years old; (4) Having a regular sexual partner and regular sexual life, having sex at least once a week, and being able to cooperate in completing this test; (5)No birth planner during the study period and within three months after the completion of the study; (6) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: Case exclusion criteria: (1)Non organic ED; (2)Patients with severe liver and kidney diseases, hematopoietic system diseases and malignant tumors, or patients with abnormal liver and kidney functions more than 1.5 times the normal value, or patients with severe gastrointestinal diseases that may affect intestinal flora, such as ulcerative colitis and rectal cancer; (3)Patients with other serious chronic basic diseases; (4)Having birth planner during the study period and within three months after the completion of the study; (5)Those who take any therapeutic drugs and health care products that may affect the experiment within three months before the first diagnosis; (6)Urinary infection; (7)Those who regularly take or abuse anti anxiety and anti depression drugs for a long time. Exclusion criteria for volunteers without ED: (1)Subjects with severe liver and kidney diseases, hematopoietic system diseases and malignant tumors, or patients with abnormal liver and kidney functions more than 1.5 times the normal value, or patients with severe gastrointestinal diseases that may affect intestinal flora, such as ulcerative colitis and rectal cancer; (2)Subjects with other serious chronic basic diseases; (3)Having birth planner during the study period and within three months after the completion of the study; (4)Those who take any therapeutic drugs and health care products that may affect the experiment within three months before the first diagnosis; (5)Urinary infection; (6)Those who regularly take or abuse anti anxiety and anti depression drugs for a long time.

Design outcomes

Primary

MeasureTime frame
AVSS-Rigiscan detection;IIEF-5 score;TCM Symptom Grading and Quantitative Score;Six sexual hormones;EQS;PHQ-9;GAD-7;

Countries

China

Contacts

Public ContactZhaojiayou

Xiyuan Hospital of China Academy of Chinese Medical Sciences

zhaojiayou520@126.com18810599934

Outcome results

None listed

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