Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy

NCT03025399 | Unknown Early Phase 1 DMC

• 1 other identifier: 2015Tangwang Prescription
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study include 384 Participants with diabetic non-proliferative retinopathy Design Method: Randomized, double blind, placebo controlled and multicenter clinical study. Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of tang wang prescription improve degree of retinal microvascular disease of patients with diabetic non-proliferative retinopathy.

Conditions

Diabetic Non-proliferative Retinopathy; Type2 Diabetes

Keywords

tang wang prescription

Outcome Measures

Primary Outcomes (1)

• the changes of degree of retinal microvascular lesions before and after treatment (no, mild non proliferative phase, moderate non proliferative phase, severe non proliferative phase, proliferative phase)

  0 week, 24 weeks, 48 weeks

Secondary Outcomes (5)

• Change of the number of micro hemangioma of diabetic retinopathy

  0 week, 24 weeks, 48 weeks

• Change of the number of microvascular bleeding of diabetic retinopathy

  0 week, 24 weeks, 48 weeks

• Change of the number of microvascular leakage of diabetic retinopathy

  0 week, 24 weeks, 48 weeks

• Degree of change of macular edema of diabetic retinopathy,analysis of measured values of the shortest distance from the margin of edema and the retinal thickness in macular region before and after medication

  0 week, 24 weeks, 48 weeks

• Change of Vision (analysis of visual acuity before and after medication using EDTRS international visual acuity chart)

  0 week, 4 weeks, 8 weeks,12 weeks,16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks

Study Arms (2)

Tangwang Prescription

EXPERIMENTAL

The prescription was composed five Chinese herbal medicines,every bag has 4.87g granules, take it one bag each time, two times a day.

Drug: Tangwang prescription

Placebo

PLACEBO COMPARATOR

Placebo is a simulated drug of tangwang Prescription,every bag has 4.87g granules, take it one bag each time, two times a day.

Drug: Placebo

Interventions

Tangwang prescription DRUG

A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.

Also known as: Tang Wang Fang

Tangwang Prescription

Placebo DRUG

Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.

Also known as: Placebos

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetic retinopathy、the degree of disease was non-proliferative diabetic retinopathy；
• Age at 30-70 years old；
• Signed the informed consent；

You may not qualify if:

• The patients with retinal photocoagulation、appropriate patients for retinal photocoagulation、patient have one or two eyes in diabetic retinopathy proliferative phase、type I diabetes mellitus、there are other eye disease complications(such as glaucoma、cataracts can Significantly interfere the fundus examination、Non - diabetic retinopathy、uveitis、amotio retinae、optic nerve diseases and high myopia with fundus lesions et al.)
• Combined with severe primary disease such as cardiovascular、liver、kidney and hematopoietic system et al、the serum transaminase was 2 times larger than the normal valuet、Serum creatinine greater than the upper limit of normal value、Psychiatric patients.
• Women with Pregnancy or prepare for pregnancy or lactating.
• Patient participated in other clinical researchers within a month.
• Patients have been treated with other drugs to treat diabetic retinopathy except for calcium hydroxide within a week.
• Systolic blood pressure \> 160mmHg or diastolic blood pressure \> 100mmHg.
• Patients with diabetic ketosis, ketoacidosis and severe infections within a month
• Patients have been alcohol abused and / or used psychoactive substances or drug abused or drug addicted within 5 years.
• According to the researcher's judgment, patients have Other lesions or conditions maybe reduce the possibility of entering groups or make the groups complex,such as working environment change frequently、Living environment is unstable what easy to cause loss to follow-up.

Sponsors & Collaborators

• Fengmei Lian: lead
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator
• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Zhengzhou City Hospital of Traditional Chinese Medicine: collaborator
• Baodin City Hospital of Traditional Chinese Medicine: collaborator
• zi bo wanjie cancer hospital: collaborator
• Shijiazhuang City Hospital of Traditional Chinese Medicine: collaborator
• Zouping Country Hospital of Traditional Chinese Medicine: collaborator

Related Publications (1)

• Jin D, Zhang Y, Zhang Y, Huang W, Meng X, Yang F, Bao Q, Zhang M, Yang Y, Ni Q, Lian F, Tong X. Efficacy and Safety of TangWang Prescription for Type 2 Non-Proliferative Diabetic Retinopathy: A Study Protocol for a Randomized Controlled Trial. Front Pharmacol. 2021 Mar 15;12:594308. doi: 10.3389/fphar.2021.594308. eCollection 2021.

  PMID: 33790783 DERIVED

Central Study Contacts

Fengmei Lian, PHD

CONTACT

0086-010-88001402; lfm565@sohu.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 19, 2017
• Study Start: February 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: January 20, 2017

Record last verified: 2017-01