| CTRI Number |
CTRI/2012/12/003259 [Registered on: 26/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
25/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A observational study to assess the efficacy of Ayurvedic treatment in eyes affected by diabetes |
|
Scientific Title of Study
|
A single centric, open labeled, observational study of selected ayurvedic therapies in the management of diabetic retinopathy, grade-1. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SARDI/02/version 01/03March2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NPP Namboothiri |
| Designation |
Managing Director and Chief Physician |
| Affiliation |
Sreedhareeyam Ayurvedic Eye Hospital and Research Centre |
| Address |
Nelliakkattu Mana
Kizhakombu Post Office Koothattukulam
Ernakulam District
Ernakulam
KERALA
686662
India |
| Phone |
91-485-2253007 |
| Fax |
91-485-2250880 |
| Email |
drnpp@sreedhareeyam.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreekanth P Namboothiri |
| Designation |
Director, Clinical Research |
| Affiliation |
Sreedhareeyam Ayurvedic Research and Development Institute |
| Address |
Nelliakkattu Mana
Kizhakombu Post Office Koothattukulam
Ernakulam District
Ernakulam
KERALA
686662
India |
| Phone |
91-485-2251578 |
| Fax |
91-485-2250880 |
| Email |
drsreekanthnp@sreedhareeyam.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darpan Gangil |
| Designation |
Junior Research Fellow |
| Affiliation |
Sreedhareeyam Ayurvedic Research and Development Institute |
| Address |
Kizhakombu Post Office Koothattukulam
Ernakulam District
Ernakulam
KERALA
686662
India |
| Phone |
91-485-2251578 |
| Fax |
91-485-2250880 |
| Email |
clinicalresearch@sreedhareeyam.com |
|
|
Source of Monetary or Material Support
|
| Sreedhareeyam Ayurvedic Eye Hospital and Research Centre
Koothattukulam Post Office
Ernakulam District
Kerala-686662
India |
|
|
Primary Sponsor
|
| Name |
Dept of AYUSH Ministry of HealthGovt of IndiaNew Delhi |
| Address |
DEPARTMENT OF AYUSH
Ministry of Health & Family Welfare
IRCS BUILDINGS (MAIN & ANNEXE)
RED CROSS ROAD, NEW DELHI - 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Sreekanth P Namboothiri |
Sreedhareeyam Ayurvedic Eye Hospital and Research Centre |
Nelliakkattu Mana
Kizhakombu Post Office Koothattukulam
Ernakulam
KERALA |
04852253007
drsreekanthnp@sreedhareeyam.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sreedhareeyam Ayurvedic Research and Development Institue |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Retinopathy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged between 30 to 80 years.
Patients presenting with signs and symptoms of Diabetic Retinopathy grade 1(US) with micro aneurysm and hemorrhage in one or two quadrants as seen in the Fundus Image.
Willing and able to participate in the study for 12 months.
|
|
| ExclusionCriteria |
| Details |
Severe cases of Diabetic Retinopathy with complications like internal haemorrhage, hard exudates, retinal detachment etc.
Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
Patient with poorly controlled Diabetes Mellitus (HbA1c > 10%)
Women who are pregnant or lactating.
Patient on steroids, oral contraceptive pills or estrogen replacement therapy.
Smokers/Alcoholics and/or drug abusers.
Patient with poorly controlled Hypertension (>160/100 mm of Hg).
Patients with evidence of malignancy.
Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.).
Any other condition which the P.I. thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fundus Photographs |
Baseline,Second Inpatient visit, Third Inpatient visit and End of study visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting Blood Sugar,Post parandial Blood Sugar,LLiver Function Test, Renal Function Test |
Baseline and End of Study Visit |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an objective of the study is
to evaluate the efficacy and safety of Ayurvedic treatment procedure and
medications in Non proliferative Diabetic Retinopathy in Sreedhareeyam
Ayurvedic Eye Hospital & Research Centre, Koothattukulam, Ernakulam
District, Kerala, India.
The aim of the study
is not to understand the efficacy of any medicine in particular, but the
efficacy of proposed Ayurvedic treatment principles in combating
Non-proliferative Diabetic Retinopathy. |