Non-proliferative Diabetic RetinopathyPhase 3NCT02388984
Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy
A Phase 3 study testing Compound danshen dripping pills in people with Non-proliferative Diabetic Retinopathy, run by Tasly Pharmaceuticals, Inc. at 16 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy
- What is being tested?
- Compound danshen dripping pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 16 sitesChina
- Study dates
- May 2013to Dec 2017
- Phase
- Phase 3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
- aged 30-70 years
- voluntary signs the informed consent
- One eye met the inclusion criteria can be used as research object, if both eyes met the inclusion criteria, please record respectively, and select one eye for efficacy evaluation with reference to the following principles:
- When the two eyes of fundus conditions in different clinical stage, choose the more serious one.
- When the two eyes of fundus conditions in the same clinical stage, choose the eye easier for clinical operation.
Who cannot join
- HbAlc>8%, sustained hyperglycemia.
- The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
- Diabetic retinopathy caused by type 1 diabetes mellitus.
- Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
- Combined with primarily severe diseases such as cardiovascular, hepatic，renal illness , hemopoietic system disease, and psychosis. Serum transaminase is higher than the limit of normal value of 1.5 times.
- Diabetic nephropathy with renal failure (Azotemia or Uremia).
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- For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs.
- Participated in other clinical trial within 3 months.
- Used drugs for the treatment of diabetic retinopathy within 1 week.
- Blood pressure > 160/100 (systolic above 160 or diastolic above 100).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
The Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130021
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410000
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610075
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Jiangsu Province Hospital of TCM
Nanjing, Jiangsu, 210029
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shenyang He Eye Hospital
Shenyang, Liaoning, 110141
Hubei Provincial Hospital of TCM
Wuhan, Hubei, 430022
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Henan Institute of Ophthalmology
Zhengzhou, Henan, 450003
About this study
Official title: A Randomized, Double Blind, Multi-Center Study of Compound Danshen Dripping Pills in Patients With Diabetic Retinopathy (Syndrome Of Qi-Stagnation and Blood Stasis)
The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).
Read the detailed description
Compound danshen dripping pills is a kind of traditional Chinese medicine(TCM), consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol. This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis), when compared with placebo.
- Conditions
- Non-proliferative Diabetic Retinopathy
- Being tested
- Compound danshen dripping pills, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound danshen dripping pillsDrug
Also called Dantonic®
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
PlaceboDrug
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Compound danshen dripping pills | Experimental | Compound danshen dripping pills,20pills,tid. Duration: 24 weeks. Receives: Drug: Compound danshen dripping pills |
| Placebo | Placebo comparator | Placebo,20pills,tid. Duration: 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo
Measured: 24weeks
Secondary outcomes (3)
Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo
Measured: 24 weeks.
Corrected visual acuity change from baseline at the end of week 24 compared to placebo
Measured: 24 weeks.
The severity of macular edema change from baseline at the end of week 24 compared to placebo
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMay 2013
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-proliferative Diabetic RetinopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Study director, Tasly Group, Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388984
- Sponsor's protocol ID
- TCM9001-04
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multi-Center Study of Compound Danshen Dripping Pills in Patients With Diabetic Retinopathy (Syndrome Of Qi-Stagnation and Blood Stasis)
- ClinicalTrials.gov ID
- NCT02388984
- Acronym / sponsor ID
- TCM9001-04
- Conditions
- Non-proliferative Diabetic Retinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Mar 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 Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).
Detailed description
Compound danshen dripping pills is a kind of traditional Chinese medicine(TCM), consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol. This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis), when compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compound danshen dripping pills | Experimental | Drug: Compound danshen dripping pillsCompound danshen dripping pills,20pills,tid. Duration: 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo,20pills,tid. Duration: 24 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
- aged 30-70 years
- voluntary signs the informed consent
- One eye met the inclusion criteria can be used as research object, if both eyes met the inclusion criteria, please record respectively, and select one eye for efficacy evaluation with reference to the following principles:
- When the two eyes of fundus conditions in different clinical stage, choose the more serious one.
Key exclusion criteria (10 listed)
- HbAlc>8%, sustained hyperglycemia.
- The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
- Diabetic retinopathy caused by type 1 diabetes mellitus.
- Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
- Combined with primarily severe diseases such as cardiovascular, hepatic，renal illness , hemopoietic system disease, and psychosis. Serum transaminase is higher than the limit of normal value of 1.5 times.
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 |
|---|---|---|
| Compound danshen dripping pillsAlso: Dantonic®Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks. | Drug | Compound danshen dripping pills |
| PlaceboDosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks. | Drug | Placebo |
Primary outcome
The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo
Time frame: 24weeks
3 secondary outcomes
Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo
Time frame: 24 weeks.
Corrected visual acuity change from baseline at the end of week 24 compared to placebo
Time frame: 24 weeks.
The severity of macular edema change from baseline at the end of week 24 compared to placebo
Time frame: 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Min Zhao, PhD study director
Tasly Group, Co. Ltd.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Compound danshen dripping pills in people with Non-proliferative Diabetic Retinopathy, run by Tasly Pharmaceuticals, Inc. at 16 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo (time frame: 24weeks). 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 21 Mar 2017.