| CTRI Number |
CTRI/2019/05/019038 [Registered on: 10/05/2019] Trial Registered Retrospectively |
| Last Modified On: |
09/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ayurvedic intervention on Diabetes induced eye disease causing vision loss. |
|
Scientific Title of Study
|
Role of Madhuyastyadi Guggulu in the management of Diabetic Retinopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BMukhopadhyay |
| Designation |
Professor |
| Affiliation |
B.H.U |
| Address |
Department of Shalakya Tantra
Faculty of Ayurveda
IMS,B.H.U
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drbijoy123@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Joshi |
| Designation |
PhD Scholar |
| Affiliation |
B.H.U |
| Address |
Department of Shalakya Tantra
Faculty of Ayurveda
IMS,B.H.U
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
joshipbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Joshi |
| Designation |
PhD Scholar |
| Affiliation |
B.H.U |
| Address |
Department of Shalakya Tantra
Faculty of Ayurveda
IMS,B.H.U
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7388167881 |
| Fax |
|
| Email |
joshipbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S.L Hospital,Institute of Medical Science,B.H.U |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Priyanka Joshi |
S.S.L Hospital,I.M.S,B.H.U |
Shalakya O.P.D Room no 13,Ophthalmology O.P.D ,S.S.L Hospital,B.H.U
Varanasi
UTTAR PRADESH |
7388167881
joshipbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Science,B.H.U Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, Diabetic patients with features of Diabetic Retinopathy , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I:Trial group
Group II:Control group |
Group I:Trial drug 500mg 2tab tds for 3month.
Group II:Placebo drug |
| Comparator Agent |
placebo |
placebo |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic patients with TypeI or TypeII diabetes mellitus with 5 or more years duration.
Patients with features of diabetic retinopathy with diabetic macular oedema(without any high risk characteristics) on examination. |
|
| ExclusionCriteria |
| Details |
1.Patients with other type of vascular retinopathies like gestational diabetic retinopathy,hypertensive retinopathy etc.
2.If patient develops any complications to treatment.
3.Patients with intravitreal injection ,operation within 3 month duration of the first visit.
4.Patient not giving consent for study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of vision
Decrease in Diabetic Macular Oedema
Improvement in signs and symptoms of diabetic retinopathy |
0,1month,2month,3month,4month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Diabetic Macular oedema |
0,1month,2month,3month,4month,5and 6month follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/04/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetic retinopathy is one of the leading cause of blindness globally.The treatment available like intravitreal VEGF,Laser photocogulation have limited role and can produce undesired effects.Therefore the treatment which lower the risk factors,minimize duration of treatment,cost effective,minimize the reoccurence etc are the need .The individual ingredients of Madhuyastyadi Guggulu have antidiabetic,antiinflammatory,antioxidant ,antineogenesis properties and hence may be effective in controlling Diabetic retinopathy and checking its progression. |