| CTRI Number |
CTRI/2018/09/015683 [Registered on: 11/09/2018] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda-Based Integrative Management Of Diabetic Retinopathy |
|
Scientific Title of Study
|
Clinical Evaluation Of Ayurveda- Based Integrative Management Of Diabetic Retinopathy |
| Trial Acronym |
DRAIM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GG Gangadharan |
| Designation |
Director |
| Affiliation |
Ramaiah Indic Specialty Ayurveda Restoration Hospital |
| Address |
Ramaiah Indic Specialty Ayurveda Restoration Hospital, Gokula Education foundation ( Medical)
New BEL Road, MSRIT Post MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9448278900 |
| Fax |
|
| Email |
msricaimresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GG Gangadharan |
| Designation |
Director |
| Affiliation |
Ramaiah Indic Specialty Ayurveda Restoration Hospital |
| Address |
Ramaiah Indic Specialty Ayurveda Restoration Hospital, Gokula Education foundation ( Medical)
New BEL Road, MSRIT Post MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9448278900 |
| Fax |
|
| Email |
msricaimresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GG Gangadharan |
| Designation |
Director |
| Affiliation |
Ramaiah Indic Specialty Ayurveda Restoration Hospital |
| Address |
Ramaiah Indic Specialty Ayurveda Restoration Hospital, Gokula Education foundation ( Medical)
New BEL Road, MSRIT Post MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9448278900 |
| Fax |
|
| Email |
msricaimresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Extra Mural Research Project,
Ministry of Ayush,
AYUSH BHAWAN, B Block,
GPO Complex, INA, NEW DELHI - 110023 |
|
|
Primary Sponsor
|
| Name |
Dr GG Gangadharan |
| Address |
Ramaiah Indic Specialty Ayurveda Restoration Hospital, Gokula Education foundation ( Medical)
New BEL Road, MSRIT Post, MSR Nagar
Bangalore -560054
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sribhargava Natesh |
Nethra Eye Hospital,
8, Poojary Layout, 80ft Road, RMV 2nd Stage, Bengaluru- 560094 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GG Gangadharan |
Ramaiah Indic Specialty Ayurveda Restoration Hospital |
Department of Research,
Clinical Research Division,
Gokula Education foundation
(Medical)
New BEL Road, MSRIT Post MSR Nagar
Bangalore -560054
Bangalore
KARNATAKA |
9448278900
msricaimresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Ramaiah Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, (2) ICD-10 Condition: H352||Other non-diabetic proliferative retinopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nishoshiradi taila,
Anutaila or Ksheerabala101 oil,
Lodhravasadi Grutha,
Nishakatakadi Kashayam,
Kaalashakadi Kashayam,
Vasaguduchyadi Kashayam. |
-Shiroabhyanga (Head massage) for 20min with 50ml of Nishoshiradi Tailam
-Kashayadhara(Irrigation of eyes with medicated decoction) 150ml made with Triphala, Yashtimadhu, Lodhra, Darvi twak, Draksha, Gairika
-Nasya(Instillation of Medicated oil in the nostrils) with Anutaila or Ksheerabala taila 101 upto 1ml.
-Tarpana(Instillation of medicated ghee,retained with eyes closed initially followed by blinking) with Lodhravasadi grutha 25ml, 15min
-Putapaka(instillation of fresh juice) of Vasamoola, Lodhra, Darvi, Anjana, Yashtimadhu, Pippali
Orally,
-Nishakatakadi Kashayam 15ml with 60ml warm water
at 6.00AM
-Kaalashaakadi Kashayam 15ml with 60ml warm water, morning, empty stomach
Vasaguduchyadi Kashayam 15ml with 60ml warm water, at 5.00pm for 6months |
| Comparator Agent |
Standard Allopathic Management
(WAIT AND WATCH APPROACH) |
Intravitreal Injections Of Bevacizumab(AVASTIN), an anti VEGF drug administered at a dose of 1.25mg in 0.05ml or laser. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Non insulin dependent diabetes mellitus
-Mild to Moderate Diabetic Retinopathy |
|
| ExclusionCriteria |
| Details |
-Patients with H/O Previous treatment for diabetic retinopathy, including laser and Anti- VEGF drug.
-Presence of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
-Other ophthalmic conditions such as Cataract etc.
-Presence of diabetic nephropathy or cardiovascular disease
-Pregnancy or Lactation
-HbA1C >10%
-Statin Use |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in the frequency and severity of manifestations of diabetic retinopathy(DR), including cotton wool spots, dot and blot hemorrhages and macular exudates |
Assessment done at baseline and 6months with Optical Coherence Tomography(OCT)
Fundus Photography(FP), Visual Acuity(V/A) and Visual Function Questionnaire(VFQ) will be done at baseline, three and six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Significant reduction of macular thickness measured using OCT in patients with diabetic macular edema.
-No significant loss of vision,i.e reduction of visual acuity by 2 lines or more on the LogMAR chart, not attributable to other visual disorders such as cataract.
-Improvement or no worsening of visual function and quality of life at the end of the Study period. |
Assessment done at baseline and 6months with Optical Coherence Tomography(OCT)
Fundus Photography(FP), Visual Acuity(V/A) and Visual Function Questionnaire(VFQ) will be done at baseline, three and six months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
1. Sharma R, Sharma S. Sahasrayogam. Hyderabad: Dakshina Prakashana, 1989
2. Vagbhata, Arunadatta, Hemadri. Ashtanga Hrudaya. Varanasi: Krishnadas Academy, 1995.
3. Mangione CM,Lee PP,Gutierrez PR, Spritzer K, Berry S, Hays RD: National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25- item National Eye Institute Visual function Questionnaire. Arch Ophthalmol.2001Jul;119(7):1050-8
4. Wilkinson CP, Ferris FL 3rd, Klein RE, Lee PP, Agardh CD, Davis M, Dills D, Kampik A, Pararajasegaram R, Verdaguer JT; Global Diabetic Retinopathy Project Group. Proposed international clinical diabetic retinopathy and diabetic macular edemaseverity scales. Ophthalmology. 2003 Sep;110(9):1677-82. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This Study will be an open label outcome assessor blinded controlled pilot trial. The purpose and objectives of the study is to evaluate the effectiveness of Ayurveda- Based integrative management in reducing the manifestations of Non-Prpoliferative Diabetic Retinopathy(NPDR) such as cotton-wool spots, dot & blot hemorrhages and macular exudates, management of Diabetic Macular Edema(DME) in patients with NPDR. This will also help evaluate the safety of Ayurveda based integrative management of Diabetic Retinopathy. Patients will be allocated to any one of the 2 groups; One group will receive Ayurveda management while the other will be observed and given Allopathy Standard of care for diabetic retinopathy, if need be.
Group-1 Standard Allopathic Management (WAIT AND WATCH APPROACH): Intravitreal Injections Of Bevacizumab(AVASTIN), an anti VEGF drug administered at a dose of 1.25mg in 0.05ml or laser. Group-2 Shiroabhyanga with -Nishoshiradi Tailam 20min -Kashayadhara with Triphala, Yashtimadhu, Lodhra, Darvi twak, Draksha, Gairika -Nasya with Anutaila or Ksheerabala taila 101 -Tarpana with Lodhravasadi grutha -Putapaka with Vasamoola, Lodhra, Darvi, Anjana, Yashtimadhu, Pippali -Nishakatakadi Kashayam 15ml with 60ml warm water at 6.00AM -Kaalashaakadi Kashayam 15ml with 60ml warm water, morning, empty stomach Vasaguduchyadi Kashayam 15ml with 60ml warm water, at 5.00pm for 6months.
Assessment will be done with the following parameters: Ocular Computerised Tomography(OCT)- measurement of retinal thickness. Fundus Photography(FP)- To evaluate number and severity of retinal hemorrhages, cotton wool spots and macular hard exudates Measurement of visual acuity using LogMAR chart, Snellens Chart, ETDRS Chart Rating of visual Function using interviewer- administered version of Visual Function Questionnaire (VFQ) 25item version.
Patients will be assessed at baseline and 6 months with OCT. FP, Visual acuity &VFQ will be done at baseline, 3 months and 6 months
Possible drug reactions from local application include uveitis, iritis, corneal or conjunctival irritation which will be monitored during the treatment and will be referred to the ophthalmologist if it is persistent. Systemic toxicity- Renal Function Tests( Serum Urea and Serum Creatinine), Liver Function tests(ALT,AST,ALP), Cardiac( Electrocardiogram) and Hematological screening( Complete hemogram including peripheral smear, WBC,RBC and Platelet count, Hemoglobin) will be done at screening and 6months. Internally administered Ayurveda drugs may reduce blood sugar, Fasting Blood glucose, Post-Prandial Blood Glucose, and Glycosylated hemoglobin done at baseline, three, six months. Urine Microalbumin will also be done to monitor diabetic status.
Certificates of Safety analysis and Standardization will be obtained for each batch from the pharmaceutical company. The fresh medicines to be used in the study will also be sent for safety analysis and standardization as per the protocol of the selected laboratory.
The following number of recruitments done under the interventional group | 1. Kamala Bai | 65/F | | 14-12-19 | | 2. S. Karim Ulla Khan | 51/F | | 17-07-20 | | 3. Sukumar T | 39/M | | 03-11-20 | | 4. Sujatha V | 60/F | | 04-11-20 | | 5. Kotresh | 56/M | | 06-02-21 | | 6. Nagabhushan Rao | 63/M | | 18-02-21 | | 7. Madaiah | 46/M | | 25-03-21 | The first patient Kamala Bai got dropped from the study due to her personal family problems. Rest are under constant follow up.
Under observation group- Mr. Shivanand Murthy 62/M is recruited.12-05-2021.
Safety analysis of 4 batches of preparations done wrt heavy metal analysis, pesticide residue, microbial assay performed.
KAP Survey questionnaire response received.
We have colloborated with Sankara Eye Hospital, Bengaluru to hasten the process of recruitment. Dr. Mahesh P Shanmugam is our Co- Investigator 2 for the project.
Sl no | Proposal No | Study Title | PI | Sub I | EC Approval | Study duration | Comments | Current status | CTRI registration number | 13 | 12 | Clinical Evaluation of Ayurveda-Based Integrative Management of Diabetic Retinopathy | Dr. Suma Sastry | Dr.Mahesh P Shanmugam | 23-Jun-20 | NA | Investigator Trial | Ongoing |
|
The study had one subject recruited but dropped due to personal issues.
|