Ayurveda-Based Integrative Management Of Diabetic Retinopathy
- Conditions
- Background retinopathy and retinalvascular changes, (2) ICD-10 Condition: H352||Other non-diabetic proliferative retinopathy,
- Registration Number
- CTRI/2018/09/015683
- Lead Sponsor
- Dr GG Gangadharan
- Brief Summary
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
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|1. Kamala Bai65/F14-12-19
|2. S. Karim Ulla Khan51/F17-07-20
|3. Sukumar T39/M03-11-20
|4. Sujatha V60/F04-11-20
|5. Kotresh56/M06-02-21
|6. Nagabhushan Rao63/M18-02-21
|7. Madaiah46/M25-03-21
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.
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|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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
Non insulin dependent diabetes mellitus -Mild to Moderate Diabetic Retinopathy.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method -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.
Trial Locations
- Locations (1)
Ramaiah Indic Specialty Ayurveda Restoration Hospital
🇮🇳Bangalore, KARNATAKA, India
Ramaiah Indic Specialty Ayurveda Restoration Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr GG GangadharanPrincipal investigator9448278900msricaimresearch@gmail.com