Chronic EczemaPhase 4NCT02601222
Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema
A Phase 4 study testing Runzao zhiyang capsule, Runzaozhiyang capsule agent simulation and Urea cream in people with Chronic Eczema, run by Guizhou Tongjitang Pharmaceutical Co.,Ltd at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Eczema
- What is being tested?
- Runzao zhiyang capsule, Runzaozhiyang capsule agent simulation and Urea cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 9 sitesChina
- Study dates
- Mar 2016to Feb 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011);
- Investigator Global Assessment (IGA) score was 2 or 3;
- The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%~10% of body surface area (estimated by palm method); the diameter of target lesions was 2~10cm and located in the limbs or trunk.
- The course of chronic eczema is more than 6 months;
- Age 18 to 70, males or females;
- The Subjects obtain informed consent, participated the trial voluntarily. Procedure to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP).
Who cannot join
- Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;
- Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;
- Subjects were treated with antihistamine and topical drugs in 2 weeks;
- Women in Pregnancy, Lactation, or Planned pregnancy during the test;
- Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;
- Subjects were allergic to test drug ingredients;
Show all 10Show fewer
- Subjects could not give full informed consent because of mental and behavioral disorders;
- Suspected or identified with a history of alcohol or drug abuse;
- Have other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting process based on the investigator judgment. For example, working environment changed frequently led to easily lost follow-up;
- Have been or currently enrolled in other clinical trials within 3 months.
Trial locations and contacts
9 sites in 1 country.
Gu heng, M.D. contact
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Li Linfeng, M.D., +86-10-63138628
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Lu Qianjin, M.D., 0731-85292097
- Recruiting
The First Affiliated Hospital of Chongqin Medical University
Chongqing, Chongqing Municipality, 400016
Li Hui, M.D., +86-25-85478045
- Recruiting
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Zeng Fanqin, M.D., +86-20-81332371
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yang Sen, M.D., +86-551-62922016
- Recruiting
Dermatology Hospital in Shandong Province
Jinan, Shandong, 250022
Zhang Furen, M.D., +86-531-87298884
- Recruiting
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, 210042
Gu Heng, M.D., 025-85478045
- Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Zhen Jie, M.D., +86-21-54661789
- Not yet recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Xu Jinhua, M.D., +86-21-52888045
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Read the detailed description
Polygoni multiflori Preparata, dried rehmannia root, mulberry leaf, sophora flavescens, Honghuoma, for skin itching, acne, constipation due to blood vacuity and wind-dryness, also used in clinical treatment of eczema.
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
- Conditions
- Chronic Eczema
- Being tested
- Runzao zhiyang capsule, Runzaozhiyang capsule agent simulation, Urea cream
- Keywords
- chronic eczema, efficacy and safety, Runzao zhiyang capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Runzao zhiyang capsuleDrug
Runzao zhiyang capsule：4 pills each time, 3 times a day, oral. Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
Runzaozhiyang capsule agent simulationDrug
Runzaozhiyang capsule agent simulation：4 pills each time, 3 times a day, oral， Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
Urea creamDrug
Topical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Runzao zhiyang capsule | Experimental | Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day. Receives: Drug: Runzao zhiyang capsule; Drug: Urea cream |
| Runzaozhiyang capsule agent simulation | Placebo comparator | Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day. Receives: Drug: Runzaozhiyang capsule agent simulation; Drug: Urea cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%
Measured: 0,4 weeks
Secondary outcomes (5)
The decrease rate of EASI in each visit compare with baseline
Measured: 0,2,4,8,12 weeks
Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline
Measured: 0,2,4,8,12 weeks
DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.
Measured: 0,2,4,8,12 weeks
The proportion of patients (EASI score greater than 10% of the patients before treatment)
Measured: 8,12 weeks
EASI score
Measured: 8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EczemaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Tongjitang Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gu heng, M.D., Principal investigator, Dermotology hospital, Chinese academy of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601222
- Sponsor's protocol ID
- Z-RZZY-JN-RS
- Status last verified
- Sep 2016
- First submitted
- 9 Oct 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema
- ClinicalTrials.gov ID
- NCT02601222
- Acronym / sponsor ID
- Z-RZZY-JN-RS
- Conditions
- Chronic Eczema
- Keywords
- chronic eczema, efficacy and safety, Runzao zhiyang capsule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guizhou Tongjitang Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Detailed description
Polygoni multiflori Preparata, dried rehmannia root, mulberry leaf, sophora flavescens, Honghuoma, for skin itching, acne, constipation due to blood vacuity and wind-dryness, also used in clinical treatment of eczema.
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Runzao zhiyang capsule | Experimental | Drug: Runzao zhiyang capsule, Drug: Urea creamRunzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day. |
| Runzaozhiyang capsule agent simulation | Placebo comparator | Drug: Runzaozhiyang capsule agent simulation, Drug: Urea creamRunzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011);
- Investigator Global Assessment (IGA) score was 2 or 3;
- The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%~10% of body surface area (estimated by palm method); the diameter of target lesions was 2~10cm and located in the limbs or trunk.
- The course of chronic eczema is more than 6 months;
- Age 18 to 70, males or females;
Key exclusion criteria (10 listed)
- Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;
- Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;
- Subjects were treated with antihistamine and topical drugs in 2 weeks;
- Women in Pregnancy, Lactation, or Planned pregnancy during the test;
- Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;
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 |
|---|---|---|
| Runzao zhiyang capsuleRunzao zhiyang capsule：4 pills each time, 3 times a day, oral. Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence. | Drug | Runzao zhiyang capsule |
| Runzaozhiyang capsule agent simulationRunzaozhiyang capsule agent simulation：4 pills each time, 3 times a day, oral， Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence. | Drug | Runzaozhiyang capsule agent simulation |
| Urea creamTopical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence. | Drug | Runzao zhiyang capsule, Runzaozhiyang capsule agent simulation |
Primary outcome
The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%
Time frame: 0,4 weeks
5 secondary outcomes
The decrease rate of EASI in each visit compare with baseline
Time frame: 0,2,4,8,12 weeks
Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline
Time frame: 0,2,4,8,12 weeks
DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.
Time frame: 0,2,4,8,12 weeks
The proportion of patients (EASI score greater than 10% of the patients before treatment)
Time frame: 8,12 weeks
EASI score
Time frame: 8,12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
Related trials for Chronic Eczema
RecruitingObservational study
Observational Analytical Validation Study of the Replior ScratchSense
Atopic Dermatitis, Pruritus
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Not yet recruiting
Efficacy and Safety of Cream Containing Fig Extract in Subacute and Chronic Eczematous Dermatitis Volunteers
Subacute and Chronic Eczematous Dermatitis Volunteers
Not yet recruitingObservational study
Skin-in-Sight: a Longitudinal Cohort Infrastructure for Standardized Remote Monitoring and the Evaluation of Digital Care Innovations in Chronic Skin Diseases
Psoriasis, Eczema/Atopic Dermatitis
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.
Gu heng, M.D. contact
Gu heng, M.D. principal investigator
Dermotology hospital, Chinese academy of medical science
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Runzao zhiyang capsule, Runzaozhiyang capsule agent simulation and Urea cream in people with Chronic Eczema, run by Guizhou Tongjitang Pharmaceutical Co.,Ltd at 9 sites in China.
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 6 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gu heng, M.D. (+86-25-85478045), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100% (time frame: 0,4 weeks). 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 20 Sep 2016.