Effectiveness and safety of Qiming granules in the treatment of nerve injury in non-proliferative diabetic retinopathy
| ISRCTN | ISRCTN39825773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39825773 |
- Submission date
- 30/08/2022
- Registration date
- 01/09/2022
- Last edited
- 19/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetic retinopathy (DR) is a complication of diabetes caused by high blood sugar levels damaging the back of the eye (retina). It is usually diagnosed and treated at a late stage when blood vessel changes occur, leading to poor effectiveness. Therefore, a new concept of DR treatment, which is targeted at nerve injury, needs to be established. This study aims to assess the effectiveness and safety of Qiming granules as an early intervention for nerve injury associated with non-proliferative DR (NPDR) (without abnormal blood vessel growth).
Who can participate?
Patients with type 2 diabetes mellitus, NPDR, and/or DR-associated nerve injury without fundus abnormalities (the part of the eyeball opposite the pupil)
What does the study involve?
Participants are randomly allocated to receive Qiming granule or calcium dobesilate (CaD) for 24 weeks. Retinal nerve fiber layer thickness and foveal avascular zone area are measured before and after 24 weeks of treatment.
What are the possible benefits and risks of participating?
It is expected that the participants receiving Qiming granules can effectively control diabetes retinopathy and improve their quality of life. The important information obtained in this study may provide a theoretical basis for retinal nerve injury in patients and help to increase their own or other patients' treatment options. During visits 1, 2 and 3, participants could obtain a transportation fee of 200 RMB per person per time. Participants may suffer side effects from the examination and drugs (for example, gastrointestinal adverse effects).
Where is the study run from?
First Affiliated Hospital of Harbin Medical University (China)
When is the study starting and how long is it expected to run for?
September 2019 to March 2022
Who is funding the study?
Beijing Bethune Charitable Foundation (China)
Who is the main contact?
Prof. Hongyu Kuang, ydykuanghongyu@126.com
Contact information
Principal Investigator
No. 23 Postal Street
Nangang District
Harbin City
Heilongjiang Province
Harbin
150001
China
| Phone | +86 (0)13339300885 |
|---|---|
| ydykuanghongyu@126.com |
Study information
| Study design | Multicenter randomized non-inferiority active-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Efficacy and safety of Qiming granules for nerve injury associated with non-proliferative diabetic retinopathy: a multicenter, randomized, non-inferiority, active-controlled clinical trial |
| Study objectives | Type 2 diabetic patients with non-proliferative diabetic retinopathy and/or nerve injury without fundus abnormalities were treated with Qiming granules and calcium dobesilate capsules for 24 weeks, respectively. Retinal neuroprotective effect and fundus improvement in the Qiming granule group are not inferior to that in the calcium dobesilate capsule group. |
| Ethics approval(s) | Approved 20/12/2019, Ethics Committee of Frist Affiliated Hospital of Harbin Medical University (No. 23 Postal Street, Nangang District, Harbin City, Heilongjiang Province, China; +86 (0)451-85552350; black9090@163.com) ref: 2019152 |
| Health condition(s) or problem(s) studied | Type 2 diabetes with non-proliferative diabetic retinopathy and/or nerve injury without fundus abnormalities |
| Intervention | The participants are randomized 1:1 into two groups. The random number sequence is generated using the PROC PLAN command in SAS 9.4 (SAS Institute, Cary, NC, USA) and enclosed in opaque anonymous envelopes. The participants in the Qiming granule group receive Qiming granules (Zhejiang Wansheng Pharmaceutical Co., Ltd., Hangzhou, China, 4.5 g) mixed with boiling water three times a day for 24 weeks. The participants in the control group receive calcium dobesilate capsules (Ebewe Pharma GmbH, Unterach am Attersee, Austria, 0.5 g) three times a day for 24 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Qiming granule, calcium dobesilate |
| Primary outcome measure | Retinal nerve fiber layer (RNFL) thickness and foveal avascular zone (FAZ) area measured using optical coherence tomography angiography (OCTA) at baseline and 24 weeks |
| Secondary outcome measures | 1. Retinal nerve fiber layer (RNFL) thickness and foveal avascular zone (FAZ) area are measured using the optical coherence tomography angiography (OCTA) at baseline and 12 weeks 2. The proportion of abnormal full-field electroretinogram (ERG) results measured using full-field ERG at baseline, 12 and 24 weeks 3. The proportion of abnormal dilated fundus examination results measured using fundoscopy at baseline, 12 and 24 weeks 4. The proportion of abnormal visual acuity measured using visual chart and comprehensive optometry at baseline,12 and 24 weeks 5. Quality of life measured using the visual function questionnaire (NEI-VFQ-25), the health survey questionnaire (SF-36 scale) and the scores of traditional Chinese medicine (TCM) syndrome element scale at baseline, 12 and 24 weeks |
| Overall study start date | 01/09/2019 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 82 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Aged 18-70 years 2. Diagnosed with type 2 diabetes mellitus according to the World Health Organization (WHO) 1999 diagnostic criteria 3. Diagnosed with nonproliferative diabetic retinopathy (NPDR) according to the 2002 International Clinical Diabetic Retinopathy Disease Severity Scale 4. Nerve injury was confirmed by electroretinogram (ERG) 5. Corrected visual acuity ≥0.8 6. Received stable hypoglycemic drug therapy for ≥3 months |
| Key exclusion criteria | 1. Other non-diabetic ocular diseases that might interfere with the results of fundus examination (such as glaucoma, cataract, non-diabetic hemorrhagic eye disease, uveitis, retinal detachment, optic nerve disease, ocular refractive interstitial abnormalities, etc) 2. Proliferative diabetic retinopathy (PDR) 3. HbA1c >8.0% 4. Diabetic retinopathy (DR) caused by type 1 or special types of diabetes 5. Intraocular surgery within 6 months, 6) central nervous system diseases 7. Allergic diseases or allergic to the study drugs 8. Participated in clinical trials within the past 3 months 9. Used drugs for the treatment of DR within the past 3 months 10. Severe systemic diseases, malignant tumors, mental illnesses, or others that might interfere with the results of this study 11. Could not take medicines as planned, or unwilling or unable to perform regular follow-up |
| Date of first enrolment | 01/02/2020 |
| Date of final enrolment | 31/03/2021 |
Locations
Countries of recruitment
- China
Study participating centres
Nangang District
Harbin City
150001
China
Yunhe District
Cangzhou City
061011
China
Jianxi District
Luoyang City
450052
China
Jiangyang District
Luzhou City
646000
China
Sponsor information
Hospital/treatment centre
No. 23 Postal Street
Nangang District
Harbin City
Heilongjiang Province
Harbin
150001
China
| Phone | +86 (0)451 85555062 |
|---|---|
| bbg@bjbqejjh.org.cn | |
| Website | http://www.54dr.com/ |
"ROR" |
https://ror.org/05vy2sc54 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 30/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the principle of informed consent which indicated that the patient's personal data will not be public. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/05/2025 | 19/05/2025 | Yes | No |
Editorial Notes
19/05/2025: Publication reference added.
31/08/2022: Trial's existence confirmed by the Ethics Committee of Frist Affiliated Hospital of Harbin Medical University.
