| CTRI Number |
CTRI/2018/05/013658 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of an Ayurvedic drug in patients of Diabetic Macular Edema |
|
Scientific Title of Study
|
A Clinical Study on the Efficacy of an Ayurvedic Intervention in the Management of Diabetic Macular Edema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruby Kumar |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalakya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
dr.rubybhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Kumar |
| Designation |
Guide for PhD thesis and Associate Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalakya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9793127744 |
| Fax |
|
| Email |
mkumarbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruby Kumar |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalakya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
dr.rubybhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Ruby Kumar |
| Address |
Department of Shalakya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University,Varanasi-221005, India
|
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ruby Kumar |
Institute of Medical Sciences |
OPD-Room No. 13 of Department of Shalakya Tantra,and OPD- Room No 7 of Department of Ophthalmology,Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
8210002352
dr.rubybhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic patients with Diabetic Macular Edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (Starch Capsules) |
250 mg (1 capsule) twice in a day for 6 months |
| Intervention |
Vidangarajanyadi Kashaya (Ayurvedic formulation) |
500 mg extract (1 capsule) of Vidangarajanyadi Kashaya twice in a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
At least one eye must meet all of the following criteria:
a) Patients equal to or more than 18 years of age, diagnosed with Type 2 diabetes mellitus having decreased vision due to macular edema associated with non-proliferative (mild to moderate) diabetic retinopathy (DR).
b) Patients with severe non-proliferative DR not willing to receive any conventional therapy for diabetic macular edema during next 6 month.
c) Diagnosis of diabetes mellitus (Type 2) - Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral antihyperglycemic agents for the treatment of diabetes
- Documented diabetes by WHO guidelines
d) Best corrected ETDRS visual acuity score equal to or more than 34 to 76 letters (approximately 6/9 to 6/60 Snellen equivalent).
e) Definite central retinal thickening of equal to or more than 300 μm due to diabetic macular edema detected by spectral domain OCT examination.
f) Patients able and willing to provide informed consent.
g) No expectation that subject will be moving out of the area of the study center during the next 6 months. |
|
| ExclusionCriteria |
| Details |
a) Patients of diabetic macular edema associated with Type I diabetes mellitus and with Proliferative DR.
b) Patients with severe non-proliferative DR willing to go for any conventional therapy for diabetic macular edema.
c) Conditions that would preclude participation in the study (e.g. unstable medical status including blood pressure and glycemic control)
- Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 6 months.
d) Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of intraocular surgery within 90 days before study entry.
e) Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the primary cause of the macular edema.
f) Ocular condition (other than diabetes) that might affect macular edema or alter visual acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome).
- Glaucoma per se is not an exclusion.
g) An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non-retinal condition).
h) Patients with a history of acute coronary event or stroke, renal failure, pregnancy or lactation.
i) Media clarity, pupillary dilation, and patient cooperation insufficient for adequate fundus and OCT examination.
j) Active participation in any type of intervention study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. To determine the change in macular retinal volume measured by optical coherence tomography (OCT).
b. To determine the change in central retinal thickness measured by optical coherence tomography (OCT). |
3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the change in best corrected visual acuity measured by ETDRS method. |
3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2018 |
| Date of Study Completion (India) |
22/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Surgical and para-surgical techniques for correction of Trichiasis and Entropion: Under-recognized contribution of ancient India
Journal Of Research and Education in Indian Medicine (JREIM)
ISSN: 0970-7700
2. Eyelid diseases: a comparison of Sushruta’s description with modern Ophthalmology
International Journal of Current Advanced Research (IJCAR))
ISSN: O: 2319-6475
ISSN: P: 2319-6505
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Purpose: To
investigate the potential of Vidanga Rajanyadi Kashaya (VRK), a
traditionally used Ayurvedic polyherbal formulation to reduce edema and improve
vision in patients of center-involved diabetic macular edema (DME).
Design: Prospective,
single-center, randomized, single-blind, placebo-controlled clinical trial.
Participants: A total
of 80 eyes of 80
center-involved DME patients were randomly allocated to receive placebo (n=41) or
VRK extract (n=39).
Methods: VRK
extract 500 mg or placebo was administered orally twice in a day for 6 months
and results were analyzed.
Main Outcome Measures: Primary
outcome measures were mean change from baseline in central retinal thickness
(CRT), maximum retinal thickness (MRT), and total macular volume (TMV) as
determined by spectral-domain optical coherence tomography. Secondary outcome
measure was the mean change from baseline in best-corrected visual acuity
(BCVA) after 3 and 6 months of treatment.
Results: Seventy
patients (35 in each group) completed the study and results were analyzed. Oral
administration of VRK extract for 6 months resulted in significant mean improvements
in CRT of 90.4 µm (p=0.000), MRT of 72.7 µm (p=0.000), TMV of 0.7
mm3 (p=0.000) and BCVA of 4.9 early treatment diabetic
retinopathy study (ETDRS) letters (p=0.000 in the study eyes. An
increase in CRT of 7.6 µm (p=0.538), MRT of 34.7 µm (p=0.021),
TMV of 0.4 mm3 (p=0.059) and decrease in BCVA of 1.5 ETDRS
letters (p=0.063) in the placebo group was observed at 6 months. No
significant ocular or systemic adverse events related to VRK 500 mg extract
were observed or reported during the study.
Conclusion: Twice
daily 500 mg extract of oral VRK administered for 6 months demonstrated
significant improvement in edema and visual acuity in patients with
center-involved DME that warrants further studies investigating the
pharmacokinetics and pharmacodynamics of the drug VRK.
. |