Depression With Erectile DysfunctionPhase 4NCT03290313
Clinical Trial Scheme of Shu Gan yi Yang Capsule
A Phase 4 study testing shu gan yi yang capsule, shu gan yi yang capsule simulation agent and Supportive psychotherapy in people with Depression With Erectile Dysfunction, run by Beijing Hospital of Traditional Chinese Medicine.
Trial summary
Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and blood stasis caused by functional impotence and mild arterial insufficiency in impotence, impotence, flaccid penis not hard or lift and… Read more about this study
- Who is it for?
- Ages 22 to 65 years, men only
- Conditions the study is for
- Depression With Erectile Dysfunction
- What is being tested?
- shu gan yi yang capsule, shu gan yi yang capsule simulation agent and Supportive psychotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for Western medicine in depression;
- MADRS score ≥ 12 points and <30 points;
- Diagnostic criteria for western medicine in line with erectile dysfunction，IIEF -5≤21points;
- TCM syndrome differentiation of liver depression and kidney deficiency in accordance with depression and erectile dysfunction;
- Male subjects, aged 22-65 years old;
- Patients who have not been treated with antidepressants or have been treated with antidepressants for more than 1 months and have reached treatment doses have no need to adjust their medications and dosages within 2 months;
- The relationship between patients and sexual partners is stable (at least in the last 6 months);
- Volunteer to participate in clinical trials, and sign informed consent.
Who cannot join
- A patient with major depressive disorder with psychotic symptoms or suicidal behavior;
- A genital anatomical abnormality (such as severe penile fibrosis) or other organic sexual dysfunction with apparent impairment of erection;
- Erectile dysfunction due to organic disease;
- Unwilling to stop other patients for depression or erectile dysfunction therapy;
- A person who has allergies or is sensitive to the ingredients of this test;
- Combined with severe primary liver and kidney diseases, aspartate aminotransferase , Alanine aminotransferase exceeded 1.5 times the normal value, and creatinine exceeded the normal limit;
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- A patient with severe somatic disease;
- Patients who have participated in other clinical trials in the past four weeks;
- A history of drug abuse or alcoholism;
- The researchers believe that patients who are not eligible for clinical trials are not eligible for clinical trials.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: a Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial of Efficacy and Safety of Shu Gan yi Yang Capsule in the Treatment of Depression Associated With Erectile Dysfunction (Stagnation of Liver qi and Kidney Deficiency)
Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and blood stasis caused by functional impotence and mild arterial insufficiency in impotence, impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness, soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string. The choice of depression associated with erectile dysfunction patients, and investigate its effect.In this study, patients with depression and erectile dysfunction were selected and the efficacy was investigated
Read the detailed description
The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation
- Conditions
- Depression With Erectile Dysfunction
- Being tested
- shu gan yi yang capsule, shu gan yi yang capsule simulation agent, Supportive psychotherapy
- Keywords
- Depression, erectile dysfunction, shu gan yi yang
- Medical subject headings
- Depression, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shu gan yi yang capsuleDrug
Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
shu gan yi yang capsule simulation agentDrug
Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
Supportive psychotherapyOther
Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
| Study group | Role | What they receive |
|---|---|---|
| shu gan yi yang capsule | Experimental | 4 capsules / time, 3 times / day, taking 8 weeks Receives: Drug: shu gan yi yang capsule; Other: Supportive psychotherapy |
| shu gan yi yang capsule capsule simulation agent | Placebo comparator | 4 capsules / time, 3 times / day, taking 8 weeks Receives: Drug: shu gan yi yang capsule simulation agent; Other: Supportive psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of The international index of erectile function (IIEF-5) total score
Each follow-up according to recent life situation, choose the best option for the 5 question, each item is scored 0-5,the total score of 5-7 divided into severe Erectile dysfunction, 8-11 divided into moderate Erectile dysfunction, 12-21 divided into mild Erectile dysfunction, 22-25 for not suffering from Erectile dysfunction (normal)
Measured: from baseline to endpoint(Week 8)
change of Montgomery Depression Rating Scale(MADRS)total score
Montgomery Depression Rating Scale includes 10 items, each item is scored 0-6 , extreme depression: MADRS≥35; severe depression: 35> MADRS≥30; moderate depression: 30> MADRS ≥ 22;Mild depression: 22> MADRS ≥ 12; remission: MADRS <12.
Measured: from baseline to endpoint(Week 8)
Secondary outcomes (3)
The change of total score of Hamilton Anxiety Scale (HAMA)
Each time the follow-up score was based on the contents of the scale，Each item is scored 0-4(0=Asymptomatic，4=extreme）
Measured: from baseline to endpoint(Week 8)
Change of traditional Chinese medicine syndrome integral
Each time the follow-up score was based on the contents of the scale，Tongue pulse does not score
Measured: from baseline to endpoint(Week 8)
A change in the effect of individual symptoms
Changes in each individual item of the scale were collected at each follow-up visit
Measured: from baseline to endpoint(Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression With Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guizhou Yi Bai Pharmaceutical Co., Ltd., Peking University Sixth Hospital, Beijing HuiLongGuan Hospital
- Responsible party
- Principal investigator, Jie Zhang,BD, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290313
- Sponsor's protocol ID
- DHZD-SGYY
- Status last verified
- Sep 2017
- First submitted
- 22 Aug 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial of Efficacy and Safety of Shu Gan yi Yang Capsule in the Treatment of Depression Associated With Erectile Dysfunction (Stagnation of Liver qi and Kidney Deficiency)
- ClinicalTrials.gov ID
- NCT03290313
- Acronym / sponsor ID
- DHZD-SGYY
- Conditions
- Depression With Erectile Dysfunction
- Keywords
- Depression, erectile dysfunction, shu gan yi yang
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guizhou Yi Bai Pharmaceutical Co., Ltd., Peking University Sixth Hospital, Beijing HuiLongGuan Hospital
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and blood stasis caused by functional impotence and mild arterial insufficiency in impotence, impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness, soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string. The choice of depression associated with erectile dysfunction patients, and investigate its effect.In this study, patients with depression and erectile dysfunction were selected and the efficacy was investigated
Detailed description
The study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shu gan yi yang capsule | Experimental | Drug: shu gan yi yang capsule, Other: Supportive psychotherapy4 capsules / time, 3 times / day, taking 8 weeks |
| shu gan yi yang capsule capsule simulation agent | Placebo comparator | Drug: shu gan yi yang capsule simulation agent, Other: Supportive psychotherapy4 capsules / time, 3 times / day, taking 8 weeks |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the diagnostic criteria for Western medicine in depression;
- MADRS score ≥ 12 points and <30 points;
- Diagnostic criteria for western medicine in line with erectile dysfunction，IIEF -5≤21points;
- TCM syndrome differentiation of liver depression and kidney deficiency in accordance with depression and erectile dysfunction;
- Male subjects, aged 22-65 years old;
Key exclusion criteria (10 listed)
- A patient with major depressive disorder with psychotic symptoms or suicidal behavior;
- A genital anatomical abnormality (such as severe penile fibrosis) or other organic sexual dysfunction with apparent impairment of erection;
- Erectile dysfunction due to organic disease;
- Unwilling to stop other patients for depression or erectile dysfunction therapy;
- A person who has allergies or is sensitive to the ingredients of this test;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shu gan yi yang capsulePatients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication | Drug | shu gan yi yang capsule |
| shu gan yi yang capsule simulation agentPatients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication | Drug | shu gan yi yang capsule capsule simulation agent |
| Supportive psychotherapyEach patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial | Other | shu gan yi yang capsule, shu gan yi yang capsule capsule simulation agent |
Primary outcome
change of The international index of erectile function (IIEF-5) total score
Time frame: from baseline to endpoint(Week 8)
Each follow-up according to recent life situation, choose the best option for the 5 question, each item is scored 0-5,the total score of 5-7 divided into severe Erectile dysfunction, 8-11 divided into moderate Erectile dysfunction, 12-21 divided into mild Erectile dysfunction, 22-25 for not suffering from Erectile dysfunction (normal)
change of Montgomery Depression Rating Scale(MADRS)total score
Time frame: from baseline to endpoint(Week 8)
Montgomery Depression Rating Scale includes 10 items, each item is scored 0-6 , extreme depression: MADRS≥35; severe depression: 35> MADRS≥30; moderate depression: 30> MADRS ≥ 22;Mild depression: 22> MADRS ≥ 12; remission: MADRS <12.
3 secondary outcomes
The change of total score of Hamilton Anxiety Scale (HAMA)
Time frame: from baseline to endpoint(Week 8)
Change of traditional Chinese medicine syndrome integral
Time frame: from baseline to endpoint(Week 8)
A change in the effect of individual symptoms
Time frame: from baseline to endpoint(Week 8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing shu gan yi yang capsule, shu gan yi yang capsule simulation agent and Supportive psychotherapy in people with Depression With Erectile Dysfunction, run by Beijing Hospital of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lili zhang (010-58462584, 1078002120@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of The international index of erectile function (IIEF-5) total score (time frame: from baseline to endpoint(Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.